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width="1.25rem" xmlns="http://www.w3.org/2000/svg"><polyline points="6 9 6 2 18 2 18 9"></polyline><path d="M6 18H4a2 2 0 0 1-2-2v-5a2 2 0 0 1 2-2h16a2 2 0 0 1 2 2v5a2 2 0 0 1-2 2h-2"></path><rect x="6" y="14" width="12" height="8"></rect></svg></a></button></div></div><div><div class="flex flex-wrap"><p class=" text-primary font-semibold">Commentary</p><div class="h-[16px] border-l-2 border-gray-400 mt-1 mx-1"></div><p class=" text-primary font-semibold">Article</p><div class="h-[16px] border-l-2 border-gray-400 mt-1 mx-1 "></div><time class="text-gray-500 " dateTime="2024-11-21T13:00:00.000">November 21, 2024</time></div><h1 class="text-[26px] font-medium leading-8">Research Priorities Evolve With Amivantamab's Broader NSCLC Indications</h1><div class="py-3 text-gray-600 md:flex flex-col md:justify-between"><div class="flex flex-col xs:flex-row"><p class="mr-1 self-start">Author(s):</p><div class="flex flex-col xs:flex-row mb-3 md:mb-0"><div class="flex flex-wrap"><span class="text-md mr-2"><a class="text-author text-gray-500 hover:text-primary underline hover:no-underline decoration-gray-400" href="/authors/maggie-l-shaw">Maggie L. Shaw</a></span></div></div></div><div class="max-w-full"><div class="flex flex-wrap sm:flex-nowrap items-center w-fit my-2"></div><div class="w-full flex flex-col sm:flex-row justify-between mt-2"><div class="block md:hidden "><div class="mt-2 flex items-center max-w-fit"><button title="Research Priorities Evolve With Amivantamab's Broader NSCLC Indications" aria-label="facebook" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#3b5998"></circle><path d="M34.1,47V33.3h4.6l0.7-5.3h-5.3v-3.4c0-1.5,0.4-2.6,2.6-2.6l2.8,0v-4.8c-0.5-0.1-2.2-0.2-4.1-0.2 c-4.1,0-6.9,2.5-6.9,7V28H24v5.3h4.6V47H34.1z" fill="white"></path></svg></button><button aria-label="twitter" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg fill="#DC7633" xmlns="http://www.w3.org/2000/svg" width="32" zoomAndPan="magnify" viewBox="0 0 375 374.9999" height="32" preserveAspectRatio="xMidYMid meet" version="1.0"><defs><path d="M 7.09375 7.09375 L 367.84375 7.09375 L 367.84375 367.84375 L 7.09375 367.84375 Z M 7.09375 7.09375 " fill="#000000"></path></defs><g><path d="M 187.46875 7.09375 C 87.851562 7.09375 7.09375 87.851562 7.09375 187.46875 C 7.09375 287.085938 87.851562 367.84375 187.46875 367.84375 C 287.085938 367.84375 367.84375 287.085938 367.84375 187.46875 C 367.84375 87.851562 287.085938 7.09375 187.46875 7.09375 " fill-opacity="1" fill-rule="nonzero" fill="#000000"></path></g><g transform="translate(85, 75)"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24" version="1.1" height="215" width="215"><path d="M18.244 2.25h3.308l-7.227 8.26 8.502 11.24H16.17l-5.214-6.817L4.99 21.75H1.68l7.73-8.835L1.254 2.25H8.08l4.713 6.231zm-1.161 17.52h1.833L7.084 4.126H5.117z" fill="#ffffff"></path></svg> </g></svg></button><button aria-label="linkedin" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#007fb1"></circle><path d="M20.4,44h5.4V26.6h-5.4V44z M23.1,18c-1.7,0-3.1,1.4-3.1,3.1c0,1.7,1.4,3.1,3.1,3.1 c1.7,0,3.1-1.4,3.1-3.1C26.2,19.4,24.8,18,23.1,18z M39.5,26.2c-2.6,0-4.4,1.4-5.1,2.8h-0.1v-2.4h-5.2V44h5.4v-8.6 c0-2.3,0.4-4.5,3.2-4.5c2.8,0,2.8,2.6,2.8,4.6V44H46v-9.5C46,29.8,45,26.2,39.5,26.2z" fill="white"></path></svg></button><button title="Research Priorities Evolve With Amivantamab's Broader NSCLC Indications" aria-label="pinterest" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#cb2128"></circle><path d="M32,16c-8.8,0-16,7.2-16,16c0,6.6,3.9,12.2,9.6,14.7c0-1.1,0-2.5,0.3-3.7 c0.3-1.3,2.1-8.7,2.1-8.7s-0.5-1-0.5-2.5c0-2.4,1.4-4.1,3.1-4.1c1.5,0,2.2,1.1,2.2,2.4c0,1.5-0.9,3.7-1.4,5.7 c-0.4,1.7,0.9,3.1,2.5,3.1c3,0,5.1-3.9,5.1-8.5c0-3.5-2.4-6.1-6.7-6.1c-4.9,0-7.9,3.6-7.9,7.7c0,1.4,0.4,2.4,1.1,3.1 c0.3,0.3,0.3,0.5,0.2,0.9c-0.1,0.3-0.3,1-0.3,1.3c-0.1,0.4-0.4,0.6-0.8,0.4c-2.2-0.9-3.3-3.4-3.3-6.1c0-4.5,3.8-10,11.4-10 c6.1,0,10.1,4.4,10.1,9.2c0,6.3-3.5,11-8.6,11c-1.7,0-3.4-0.9-3.9-2c0,0-0.9,3.7-1.1,4.4c-0.3,1.2-1,2.5-1.6,3.4 c1.4,0.4,3,0.7,4.5,0.7c8.8,0,16-7.2,16-16C48,23.2,40.8,16,32,16z" fill="white"></path></svg></button><button aria-label="email" class="react-share__ShareButton" style="background-color:transparent;border:none;padding:0;font:inherit;color:inherit;cursor:pointer"><svg viewBox="0 0 64 64" width="32" height="32"><circle cx="32" cy="32" r="31" fill="#7f7f7f"></circle><path d="M17,22v20h30V22H17z M41.1,25L32,32.1L22.9,25H41.1z M20,39V26.6l12,9.3l12-9.3V39H20z" fill="white"></path></svg></button><a class="print-wrap flex justify-center items-center cursor-pointer"><svg id="print" xmlns="http://www.w3.org/2000/svg" width="24" height="24" fill="currentColor" class="print bi bi-printer" viewBox="0 0 16 16"> <path d="M2.5 8a.5.5 0 1 0 0-1 .5.5 0 0 0 0 1z"></path> <path d="M5 1a2 2 0 0 0-2 2v2H2a2 2 0 0 0-2 2v3a2 2 0 0 0 2 2h1v1a2 2 0 0 0 2 2h6a2 2 0 0 0 2-2v-1h1a2 2 0 0 0 2-2V7a2 2 0 0 0-2-2h-1V3a2 2 0 0 0-2-2H5zM4 3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1v2H4V3zm1 5a2 2 0 0 0-2 2v1H2a1 1 0 0 1-1-1V7a1 1 0 0 1 1-1h12a1 1 0 0 1 1 1v3a1 1 0 0 1-1 1h-1v-1a2 2 0 0 0-2-2H5zm7 2v3a1 1 0 0 1-1 1H5a1 1 0 0 1-1-1v-3a1 1 0 0 1 1-1h6a1 1 0 0 1 1 1z"></path></svg></a></div><style> .print-wrap { width: 32px; height: 32px; background: #7F7F7F; border-radius: 100%; } .print { background: #7F7F7F; color: white; padding: 2px; border-radius: 100%; } </style></div></div></div></div><div class=" lg:w-full flex flex-col lg:flex-row lg:items-center lg:justify-end"><div class="related-landing sm:w-auto md:max-w-fit lg:w-[auto] md:text-center my-2 md:my-0 p-0 sm:px-4"><a class="" href="/partners/us-oncology-network"><div class="relative max-w-[300px]"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27262.3666666666667%27%20height=%2751%27/%3e"/></span><img src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" class="shrink-0" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F4c487c84faffb9c415baa61497e29cc2d9b429d4-926x180.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F4c487c84faffb9c415baa61497e29cc2d9b429d4-926x180.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F4c487c84faffb9c415baa61497e29cc2d9b429d4-926x180.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a></div></div><p class="py-2 mb-2 text-sm italic text-gray-600">In September, amivantamab (Rybrevant; Johnson & Johnson) received its fourth treatment indication from the FDA to treat non–small cell lung cancer (NSCLC).</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><div class="relative"><div class="brightcove-fluid" autoplay=""></div></div><p class="pb-2"></p><p class="pb-2">Continuing our discussion with Martin Dietrich, MD, PhD, thoracic oncologist with The US Oncology Network and Cancer Care Centers of Brevard in Orlando, Florida, about <a target="_blank" href="https://www.ajmc.com/view/fda-approves-amivantamab-for-egfr-positive-nsclc-with-exon-19-deletion-exon-21-l858r-substitution">the most recent approval for amivantamab</a> in <a target="_blank" href="https://www.ajmc.com/compendium/nsclc">non–small cell lung cancer</a> (NSCLC), here he examines unmet treatment needs for the subset of patients who have exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) treatment, whom the newest indication covers, and what should be current research priorities.</p><p class="pb-2"></p><p class="pb-2">Amivantamab currently has 4 approved indications from the FDA, and along with chemotherapy, it is the only Category 1 treatment per National Comprehensive Cancer Network Guidelines for patients with <em>EGFR</em>-mutated NSCLC who are progressing on osimertinib with multiple lesions.</p><p class="pb-2"></p><p class="pb-2"><em>This transcript has been edited for clarity.</em></p><p class="pb-2"></p><p class="pb-2"><strong><span style="text-decoration:underline">Transcript</span></strong></p><p class="pb-2"></p><p class="pb-2"><strong>What unmet treatment needs does this latest approval address?</strong></p><p class="pb-2"></p><p class="pb-2">The versatility of amivantamab is very broad. <a target="_blank" href="https://www.ajmc.com/view/amivantamab-accolades-add-up-for-nsclc">I mentioned</a> the indication in first-line EGFR exon 19 and 21 in MARIPOSA, first-line EGFR exon 20 in PAPILLON, the post progression in MARIPOSA-2, as well as the CHRYSALIS [NCT02609776] data that had the single-agent indication for EGFR exon 20. So it really tells you that it captures all of the difficult intracellular kinase domain processes that are not as easily approachable by a tyrosine kinase small molecule.</p><p class="pb-2"></p><p class="pb-2">We are seeing, obviously, still concerns about durability. We're still learning about overall survival.Those trials, while they've had very good initial results, are still maturing. We're still trying to see the optimal sequence and trying to refine which patient benefits the most from these therapies. Are there patients that are fine with monotherapy alone? Whenever we add additional therapy combinations, we always expect an increase in side effects.</p><p class="pb-2"></p><p class="pb-2">So we're still learning a lot about the biomarker space, and there's still a lot of improvements and tailoring that can be made for patients to really optimize outcomes. Prospectively, I'm excited about these lessons. I think it has been a priority to take the lessons from MARIPOSA and MARIPOSA-2 back into new clinical trial designs that help us refine the way we give the medication—both in frequency and application route—expecting a subcutaneous injection over the intravenous route that we're currently using.I think we'll be seeing additional insight and protocols with regards to management of skin toxicities.</p><p class="pb-2"></p><p class="pb-2">So there is more to be learned, and I think that's always the beautiful part of a clinical trial. It is a lesson that answers as many questions as it poses, and so a continuous driver, if we take it on, as a continuous learning lesson.</p><p class="pb-2"></p><p class="pb-2">And then prospectively, obviously, a side of amivantamab that we haven't really tackled in our discussion at all is, obviously, we know that CMET is an escape mechanism for post progression on an EGFR TKI in the first-line setting, but CMET plays a role individually in non–small cell lung cancer as well, both through amplification and through intercellular kinase domain alterations, including the MET exon 14 skipping mutation that essentially leads to a decreased turnover on the intracellular side and a decrease in protein reduction by ubiquitous retention.So I think there's still a lot more development to be seen with the amivantamab molecule.</p><p class="pb-2"></p><p class="pb-2">Unfortunately, even though patients are doing better, we're still in the process of now resorting our thoughts not only with regards to who do we select what first-line therapy for, but also what are we going to do when a patient progresses? What therapies do we use in the first line, and then how would this influence second- and third-line treatment for our patients? So always good to have new options, but the complexity is getting higher and higher. It used to be sort of a 1-drug space, and that has certainly been augmented broadly with these new approvals.</p><p class="pb-2"></p><p class="pb-2"><strong>Can you discuss what should be research priorities moving forward in patients with <em>EGFR</em>-mutated NSCLC?</strong></p><p class="pb-2"></p><p class="pb-2">In this scenario, we're talking about really the complexity of the <em>EGFR</em> mutation family, and we are having mutations in exon 18, 19, 20, and 21. And while MARIPOSA addresses mutations in exon 19 and 21, the specifically referenced regimen, the PAPILLON regimen, references mutations in EGFR exon 20. It's a very difficult-to-treat subset where we had very limited success obtaining small molecule inhibitors that would mimic the response pattern that we've seen in exon 19 and 21.</p><p class="pb-2"></p><p class="pb-2">So, it's the same receptor, similar mutations, but clinically very, very difficult to treat. And we were having 2 options for treatment in the second-line setting for EGFR exon 20: amivantamab as a monotherapy based on the CHRYSALIS study, and we had for a brief period of time also mobocertinib as a targeted therapy—that has been <a rel="nofollow noreferrer noopener" target="_blank" href="https://www.takeda.com/newsroom/newsreleases/2023/takeda-provides-update-on-exkivity-mobocertinib/">removed by the FDA</a>. But now we've seen the results of the PAPILLON study, where we combine chemotherapy as the previous first-line standard of care in the EGFR exon 20 population, and adding amivantamab, and we're seeing a doubling in the progression-free survival.</p><p class="pb-2"></p><p class="pb-2">We're seeing very nice and deep responses, with about 60% response rates in this subgroup. This adds to the reach of amivantamab by basically overcoming any intracellular kinase domain alterations by tackling the EGFR receptor from the extracellular side. So, it shows the versatility of the agent, basically reaching any EGFR alteration in this subset of treatment.</p><p class="pb-2"></p><p class="pb-2">We've seen some data published also for the atypical mutations. And again, agnostically and biologically, there's absolutely no reason why amivantamab wouldn't be helpful in this subset, so we're using it. 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text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent">Frameworks for Advancing Health Equity: Wellness Way</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The Wellness Way facility was designed to improve access to comprehensive outpatient care and address social determinants of health for a diverse patient population.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/putting-patients-first-by-extending-the-reach-of-world-class-care?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/6516d8b0c252437264857346e08513d6f261f8f3-400x400.png?fit=crop&auto=format" alt="City of Hope logo | Image: City of Hope" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/putting-patients-first-by-extending-the-reach-of-world-class-care?utm_source=www.ajmc.com&utm_medium=relatedContent">Putting Patients First by Extending the Reach of World-Class Care</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/mary-caffrey">Mary Caffrey</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/putting-patients-first-by-extending-the-reach-of-world-class-care?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Institute for Value-Based Medicine event with City of Hope.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4d74ae04b0508977864936ec08f2aaa199758e5c-1000x563.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">October 29th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent">Breaking the Cycle: The Importance of Early Intervention in Hidradenitis Suppurativa</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Prompt care supports mental well-being, as hidradenitis suppurativa is often associated with depression and anxiety due to its physical and social challenges.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tepotinib-in-met-exon-14-mnsclc?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a8618a304818f2e790cceaaee500fb88668d0d17-1200x738.jpg?fit=crop&auto=format" alt="FDA | Image Credit: © Artur-stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 18th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tepotinib-in-met-exon-14-mnsclc?utm_source=www.ajmc.com&utm_medium=relatedContent">FDA Approves Companion Diagnostic for Tepotinib in MET Exon 14 mNSCLC</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/ashling-wahner">Ashling Wahner</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tepotinib-in-met-exon-14-mnsclc?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA approved the FoundationOne Liquid CDx to identify patients with metastatic non–small cell lung cancer (mNSCLC) with MET exon 14 skipping alterations who may be eligible for tepotinib (Tepmetko; EMD Serono).</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/latest-from-the-finearts-hf-trial-no-sex-specific-differences-reported-in-finenerone-outcomes-for-heart-failure?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4760e0a286de287b8e7d1ba3868814a0d6b395d9-2880x1618.png?fit=crop&auto=format" alt="Latest From FINEARTS-HF: No Sex-Specific Differences in Finerenone Outcomes for Heart Failure" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 18th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/latest-from-the-finearts-hf-trial-no-sex-specific-differences-reported-in-finenerone-outcomes-for-heart-failure?utm_source=www.ajmc.com&utm_medium=relatedContent">Latest From FINEARTS-HF: No Sex-Specific Differences in Finerenone Outcomes for Heart Failure</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/kyle-munz">Kyle Munz</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/latest-from-the-finearts-hf-trial-no-sex-specific-differences-reported-in-finenerone-outcomes-for-heart-failure?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FINEARTS-HF trial offered novel clinical insights as one of the few cardiovascular trials to feature such a great proportion of female participants. </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div></div></div></div><div class="relative hidden sm:block"><div class="mt-4 overflow-hidden"><div class="flex justify-between"><div class="flex items-center clear-both pt-4 pb-2 text-3xl lg:text-2xl xl:text-3xl min-w-fit ">Related Content </div><div class="hidden lg:flex w-full flex-col justify-end items-end"><div class="hidden w-full lg:flex flex-wrap pb-2 gap-x-2 gap-y-1 justify-end items-end"></div></div></div><div class="w-full mb-2 border border-secondary"></div><div class="lg:hidden flex flex-wrap items-center"></div><div class="flex flex-wrap w-full"><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-1"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/balancing-life-and-myeloma-a-patient-centered-approach?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/6c4eacfe9c992d1f7ea48bbb7606ade7b9a0b9cf-1920x1080.jpg?fit=crop&auto=format" alt="Don M. Benson, MD, PhD, James Cancer Hospital" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 22nd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/balancing-life-and-myeloma-a-patient-centered-approach?utm_source=www.ajmc.com&utm_medium=relatedContent">Balancing Life and Myeloma: A Patient-Centered Approach</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/maggie-l-shaw">Maggie L. Shaw</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/balancing-life-and-myeloma-a-patient-centered-approach?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">In this second part of our discussion with Don M. Benson, MD, PhD, from our recent Institute for Value-Based Medicine® event in Cleveland, Ohio, he explains how his ultimate goal for his patients is for them to live as long and as well as possible.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a1728e6a06fccde8af20d2308f860344f9776b8f-800x400.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent">Frameworks for Advancing Health Equity: Wellness Way</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/frameworks-for-advancing-health-equity-wellness-way?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The Wellness Way facility was designed to improve access to comprehensive outpatient care and address social determinants of health for a diverse patient population.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/putting-patients-first-by-extending-the-reach-of-world-class-care?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/6516d8b0c252437264857346e08513d6f261f8f3-400x400.png?fit=crop&auto=format" alt="City of Hope logo | Image: City of Hope" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 21st 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/putting-patients-first-by-extending-the-reach-of-world-class-care?utm_source=www.ajmc.com&utm_medium=relatedContent">Putting Patients First by Extending the Reach of World-Class Care</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/mary-caffrey">Mary Caffrey</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/putting-patients-first-by-extending-the-reach-of-world-class-care?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Institute for Value-Based Medicine event with City of Hope.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4d74ae04b0508977864936ec08f2aaa199758e5c-1000x563.jpg?fit=crop&auto=format" alt="Managed Care Cast" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">October 29th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent">Breaking the Cycle: The Importance of Early Intervention in Hidradenitis Suppurativa</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/breaking-the-cycle-the-importance-of-early-intervention-in-hidradenitis-suppurativa?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Prompt care supports mental well-being, as hidradenitis suppurativa is often associated with depression and anxiety due to its physical and social challenges.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tepotinib-in-met-exon-14-mnsclc?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a8618a304818f2e790cceaaee500fb88668d0d17-1200x738.jpg?fit=crop&auto=format" alt="FDA | Image Credit: © Artur-stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 18th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tepotinib-in-met-exon-14-mnsclc?utm_source=www.ajmc.com&utm_medium=relatedContent">FDA Approves Companion Diagnostic for Tepotinib in MET Exon 14 mNSCLC</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/ashling-wahner">Ashling Wahner</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tepotinib-in-met-exon-14-mnsclc?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA approved the FoundationOne Liquid CDx to identify patients with metastatic non–small cell lung cancer (mNSCLC) with MET exon 14 skipping alterations who may be eligible for tepotinib (Tepmetko; EMD Serono).</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/latest-from-the-finearts-hf-trial-no-sex-specific-differences-reported-in-finenerone-outcomes-for-heart-failure?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4760e0a286de287b8e7d1ba3868814a0d6b395d9-2880x1618.png?fit=crop&auto=format" alt="Latest From FINEARTS-HF: No Sex-Specific Differences in Finerenone Outcomes for Heart Failure" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">November 18th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/latest-from-the-finearts-hf-trial-no-sex-specific-differences-reported-in-finenerone-outcomes-for-heart-failure?utm_source=www.ajmc.com&utm_medium=relatedContent">Latest From FINEARTS-HF: No Sex-Specific Differences in Finerenone Outcomes for Heart Failure</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/kyle-munz">Kyle Munz</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/latest-from-the-finearts-hf-trial-no-sex-specific-differences-reported-in-finenerone-outcomes-for-heart-failure?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FINEARTS-HF trial offered novel clinical insights as one of the few cardiovascular trials to feature such a great proportion of female participants. </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div></div></div></div><div class="pb-24"></div></div><script type="application/ld+json">{"@context":"https://schema.org","@type":"NewsArticle","headline":"Research Priorities Evolve With Amivantamab's Broader NSCLC Indications","datePublished":"2024-11-21T13:00:00.000Z","dateModified":"2024-11-19T18:23:04Z","inLanguage":"en-US","image":"https://cdn.sanity.io/images/0vv8moc6/ajmc/b924e135f2e0564215c00b9b28af5867586299e6-1200x675.jpg?fit=crop&auto=format","mainEntityOfPage":{"@type":"WebPage","@id":"https://www.ajmc.com/view/research-priorities-evolve-with-amivantamab-s-broader-nsclc-indications"},"publisher":{"@type":"Organization","name":"AJMC","logo":{"@type":"ImageObject","url":"https://www.ajmc.com/ajmc_logo_inverted.png"}},"keywords":"NSCLC,EGFR-Mutated NSCLC Treatment,EGFR exon 20,amivantamab,Martin Dietrich","articleBody":"\n\n\n\nContinuing our discussion with Martin Dietrich, MD, PhD, thoracic oncologist with The US Oncology Network and Cancer Care Centers of Brevard in Orlando, Florida, about the most recent approval for amivantamab in non–small cell lung cancer (NSCLC), here he examines unmet treatment needs for the subset of patients who have exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) treatment, whom the newest indication covers, and what should be current research priorities.\n\n\n\nAmivantamab currently has 4 approved indications from the FDA, and along with chemotherapy, it is the only Category 1 treatment per National Comprehensive Cancer Network Guidelines for patients with EGFR-mutated NSCLC who are progressing on osimertinib with multiple lesions.\n\n\n\nThis transcript has been edited for clarity.\n\n\n\nTranscript\n\n\n\nWhat unmet treatment needs does this latest approval address?\n\n\n\nThe versatility of amivantamab is very broad. I mentioned the indication in first-line EGFR exon 19 and 21 in MARIPOSA, first-line EGFR exon 20 in PAPILLON, the post progression in MARIPOSA-2, as well as the CHRYSALIS [NCT02609776] data that had the single-agent indication for EGFR exon 20. So it really tells you that it captures all of the difficult intracellular kinase domain processes that are not as easily approachable by a tyrosine kinase small molecule.\n\n\n\nWe are seeing, obviously, still concerns about durability. We're still learning about overall survival.Those trials, while they've had very good initial results, are still maturing. We're still trying to see the optimal sequence and trying to refine which patient benefits the most from these therapies. Are there patients that are fine with monotherapy alone? Whenever we add additional therapy combinations, we always expect an increase in side effects.\n\n\n\nSo we're still learning a lot about the biomarker space, and there's still a lot of improvements and tailoring that can be made for patients to really optimize outcomes. Prospectively, I'm excited about these lessons. I think it has been a priority to take the lessons from MARIPOSA and MARIPOSA-2 back into new clinical trial designs that help us refine the way we give the medication—both in frequency and application route—expecting a subcutaneous injection over the intravenous route that we're currently using.I think we'll be seeing additional insight and protocols with regards to management of skin toxicities.\n\n\n\nSo there is more to be learned, and I think that's always the beautiful part of a clinical trial. It is a lesson that answers as many questions as it poses, and so a continuous driver, if we take it on, as a continuous learning lesson.\n\n\n\nAnd then prospectively, obviously, a side of amivantamab that we haven't really tackled in our discussion at all is, obviously, we know that CMET is an escape mechanism for post progression on an EGFR TKI in the first-line setting, but CMET plays a role individually in non–small cell lung cancer as well, both through amplification and through intercellular kinase domain alterations, including the MET exon 14 skipping mutation that essentially leads to a decreased turnover on the intracellular side and a decrease in protein reduction by ubiquitous retention.So I think there's still a lot more development to be seen with the amivantamab molecule.\n\n\n\nUnfortunately, even though patients are doing better, we're still in the process of now resorting our thoughts not only with regards to who do we select what first-line therapy for, but also what are we going to do when a patient progresses? What therapies do we use in the first line, and then how would this influence second- and third-line treatment for our patients? So always good to have new options, but the complexity is getting higher and higher. It used to be sort of a 1-drug space, and that has certainly been augmented broadly with these new approvals.\n\n\n\nCan you discuss what should be research priorities moving forward in patients with EGFR-mutated NSCLC?\n\n\n\nIn this scenario, we're talking about really the complexity of the EGFR mutation family, and we are having mutations in exon 18, 19, 20, and 21. And while MARIPOSA addresses mutations in exon 19 and 21, the specifically referenced regimen, the PAPILLON regimen, references mutations in EGFR exon 20. It's a very difficult-to-treat subset where we had very limited success obtaining small molecule inhibitors that would mimic the response pattern that we've seen in exon 19 and 21.\n\n\n\nSo, it's the same receptor, similar mutations, but clinically very, very difficult to treat. And we were having 2 options for treatment in the second-line setting for EGFR exon 20: amivantamab as a monotherapy based on the CHRYSALIS study, and we had for a brief period of time also mobocertinib as a targeted therapy—that has been removed by the FDA. But now we've seen the results of the PAPILLON study, where we combine chemotherapy as the previous first-line standard of care in the EGFR exon 20 population, and adding amivantamab, and we're seeing a doubling in the progression-free survival.\n\n\n\nWe're seeing very nice and deep responses, with about 60% response rates in this subgroup. This adds to the reach of amivantamab by basically overcoming any intracellular kinase domain alterations by tackling the EGFR receptor from the extracellular side. So, it shows the versatility of the agent, basically reaching any EGFR alteration in this subset of treatment.\n\n\n\nWe've seen some data published also for the atypical mutations. And again, agnostically and biologically, there's absolutely no reason why amivantamab wouldn't be helpful in this subset, so we're using it. But for EGFR exon 20, it's really the only approved standard-of-care option that is evidence based.","description":"In September, amivantamab (Rybrevant; Johnson & Johnson) received its fourth treatment indication from the FDA to treat non–small cell lung cancer (NSCLC).","author":[{"@type":"Person","name":"Maggie L. Shaw"}]}</script></div></div><div class="flex-none w-[300px] z-[9999] relative hidden md:block"><div style="top:5rem" class="sticky custom-spacing"><div class="collapse-container " style="overflow:hidden;max-height:900px;transition:max-height .4s ease-in-out"></div></div></div></div><div id="div-gpt-ad-pixel" style="width:1px;height:1px" class=""></div><noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-NK5KQXS" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript><div id="footerOuterWrap" class=" mx-auto flex"><div class="bg-[#00598D] xl:w-[70%] w-[70%] py-12 pl-auto"><div class="xxl:w-[75%] w-[90%] ml-auto"><div><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span 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","_key":"e7f5faf8a2970"},{"marks":["4d69bbd233df"],"text":"I mentioned","_key":"e7f5faf8a2971","_type":"span"},{"_type":"span","marks":[],"text":" the indication in first-line EGFR exon 19 and 21 in MARIPOSA, first-line EGFR exon 20 in PAPILLON, the post progression in MARIPOSA-2, as well as the CHRYSALIS [NCT02609776] data that had the single-agent indication for EGFR exon 20. So it really tells you that it captures all of the difficult intracellular kinase domain processes that are not as easily approachable by a tyrosine kinase small molecule.","_key":"e7f5faf8a2972"}],"_type":"block","upload_doc":null,"uploadAudio":null},{"markDefs":[],"children":[{"text":"","_key":"e0b26f99564f0","_type":"span","marks":[]}],"_type":"block","upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"5e5afe9e6d20"},{"children":[{"_type":"span","marks":[],"text":"We are seeing, obviously, still concerns about durability. We're still learning about overall survival.Those trials, while they've had very good initial results, are still maturing. We're still trying to see the optimal sequence and trying to refine which patient benefits the most from these therapies. Are there patients that are fine with monotherapy alone? Whenever we add additional therapy combinations, we always expect an increase in side effects.","_key":"f16e085683b70"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"2b7e279d11d7","markDefs":[]},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"marks":[],"text":"","_key":"7ae22fd46fd40","_type":"span"}],"_type":"block","style":"normal","_key":"765819e017d3","upload_doc":null},{"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"So we're still learning a lot about the biomarker space, and there's still a lot of improvements and tailoring that can be made for patients to really optimize outcomes. Prospectively, I'm excited about these lessons. I think it has been a priority to take the lessons from MARIPOSA and MARIPOSA-2 back into new clinical trial designs that help us refine the way we give the medication—both in frequency and application route—expecting a subcutaneous injection over the intravenous route that we're currently using.I think we'll be seeing additional insight and protocols with regards to management of skin toxicities.","_key":"eb55346cf0df0"}],"_type":"block","style":"normal","_key":"6ffb276f5c11","upload_doc":null},{"children":[{"_type":"span","marks":[],"text":"","_key":"19862b2906240"}],"_type":"block","style":"normal","_key":"9c83a597786d","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"medias":null,"style":"normal","_key":"070cc569aa37","markDefs":[],"children":[{"_key":"ddca81f3a3e90","_type":"span","marks":[],"text":"So there is more to be learned, and I think that's always the beautiful part of a clinical trial. It is a lesson that answers as many questions as it poses, and so a continuous driver, if we take it on, as a continuous learning lesson."}],"_type":"block","upload_doc":null,"uploadAudio":null},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"700c12972b3d","markDefs":[],"children":[{"marks":[],"text":"","_key":"69e774ada1430","_type":"span"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"8dcf7b70af2c","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"text":"And then prospectively, obviously, a side of amivantamab that we haven't really tackled in our discussion at all is, obviously, we know that CMET is an escape mechanism for post progression on an EGFR TKI in the first-line setting, but CMET plays a role individually in non–small cell lung cancer as well, both through amplification and through intercellular kinase domain alterations, including the MET exon 14 skipping mutation that essentially leads to a decreased turnover on the intracellular side and a decrease in protein reduction by ubiquitous retention.So I think there's still a lot more development to be seen with the amivantamab molecule.","_key":"ba5fb1a7a7140","_type":"span","marks":[]}]},{"children":[{"_key":"c8a6fc73965d0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"8f4e9f23fec9","markDefs":[],"upload_doc":null,"uploadAudio":null,"medias":null},{"children":[{"_type":"span","marks":[],"text":"Unfortunately, even though patients are doing better, we're still in the process of now resorting our thoughts not only with regards to who do we select what first-line therapy for, but also what are we going to do when a patient progresses? 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Benson, MD, PhD"},"_type":"video","caption":"Don M. Benson, MD, PhD, James Cancer Hospital"},{"markDefs":[],"children":[{"_key":"411d0a4269f6","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"ef45127706c5"},{"_key":"913bedb4e58c","markDefs":[{"blank":true,"_type":"link","href":"https://www.ajmc.com/compendium/multiple-myeloma","_key":"5a0178e4c1ba","nofollow":false}],"children":[{"_type":"span","marks":[],"text":"In our ongoing discussion with Don M. Benson, MD, PHD, The Ohio State University Comprehensive Cancer Center, who moderated the ","_key":"2592f014ca730"},{"text":"multiple myeloma","_key":"0af77768d6e5","_type":"span","marks":["5a0178e4c1ba"]},{"_type":"span","marks":[],"text":" panel discussion at our recent Institute for Value-Based Medicine","_key":"cf217c02123f"},{"_type":"span","marks":["superscript"],"text":"®","_key":"f4ec3272c8b3"},{"_type":"span","marks":[],"text":" event in Cleveland, Ohio, he explains what are his top priorities for his patients throughout their treatment journey for multiple myeloma and how caring for them is a true partnership.","_key":"81972df0b58e"}],"_type":"block","style":"normal"},{"style":"normal","_key":"462a4228e945","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"8c1ad11449210"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"As a hematologist-oncologist, Benson has cared for patients at James Cancer Hospital for 22 years, where he strives to enable his patients to live as long and as well as possible, he explains in this clip.","_key":"9449e83194530"}],"_type":"block","style":"normal","_key":"22febbd0ab00"},{"children":[{"_type":"span","marks":[],"text":"","_key":"638191e129540"}],"_type":"block","style":"normal","_key":"3de47787d4c5","markDefs":[]},{"style":"normal","_key":"046ca8e6eaef","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“We make it work,” he says, “and that's amazing because, again, we didn't do that 20 years ago.\"","_key":"cc994e6256690"}],"_type":"block"},{"_key":"bc9deeee28b0","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"80c96e0d37ef0"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"130d0899d593","markDefs":[],"children":[{"_type":"span","marks":["em"],"text":"The transcript has been lightly edited for clarity.","_key":"37ebafbb69890"}]},{"markDefs":[],"children":[{"_key":"6510ab3f88b00","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"38a76c774d84"},{"style":"normal","_key":"eff4cdd2ca8c","markDefs":[],"children":[{"_type":"span","marks":["strong","underline"],"text":"Transcript","_key":"c419739049240"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"b8634f56af260"}],"_type":"block","style":"normal","_key":"a6d1ef38925d"},{"_type":"block","style":"normal","_key":"2d601c3ed554","markDefs":[],"children":[{"marks":["strong"],"text":"What factors should guide the choice between traditional transplant options and newer immunotherapy approaches for newly diagnosed or relapsed disease?","_key":"e7fe88b227810","_type":"span"}]},{"children":[{"_type":"span","marks":[],"text":"","_key":"141e674a7a2e0"}],"_type":"block","style":"normal","_key":"055f18a117ef","markDefs":[]},{"_type":"block","style":"normal","_key":"a1c302885f65","markDefs":[],"children":[{"marks":[],"text":"When I meet somebody with myeloma, my goal is for them to live as long as possible and as well as possible. Leaving the complexities aside for a second, the principal goal of induction treatment is to alleviate suffering, get symptoms under control, get the disease in remission. I tell my patients, we're going to play offense, we're going to take the ball. We're playing offense, and the goal is a complete remission. The goal is to get you back to life before you heard those words that you have myeloma.","_key":"98a12fa87f160","_type":"span"}]},{"_type":"block","style":"normal","_key":"b87ccab950ce","markDefs":[],"children":[{"marks":[],"text":"","_key":"e5122cc087dd0","_type":"span"}]},{"_key":"4fa1f2e9a11a","markDefs":[],"children":[{"_type":"span","marks":[],"text":"We’re blessed. We can achieve that now for the vast majority of people within a few months.The challenge really isn't getting the disease under control nowadays, it's doing it in a way to minimize toxicities, minimize side effects, even down to things like time. How long are you in the clinic? How long are you away from your life? These are things that we never would have thought of 20 years ago. So I think starting with principles and then moving forward, once the disease is in remission.","_key":"903297a2544e0"}],"_type":"block","style":"normal"},{"children":[{"marks":[],"text":"","_key":"d68b2f25f9270","_type":"span"}],"_type":"block","style":"normal","_key":"350f7d4b1a54","markDefs":[]},{"style":"normal","_key":"0e3a9819924f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"We talk a little bit about this shared decision-making model of, we have a panoply of options available. What makes sense for you with your myeloma right now? Realizing that that answer might be different 2 years from now or 5 years from now. But what can we do right now to stay on our true north, that I want you to live as long as possible and as well as possible. And for some people, that's a transplant.For some people, that's maybe a CAR [chimeric antigen receptor] T cell. For some people, that might be stopping treatment and just taking a maintenance drug.","_key":"6f14e254c8760"}],"_type":"block"},{"_key":"db2656198b38","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"cb0db495ec3c0"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"6d35a1abcd26","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"What strategies can be implemented to support caregivers and enhance patient engagement throughout this journey?","_key":"e44a4e9608260"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"1dce3cf224050"}],"_type":"block","style":"normal","_key":"6c3f5f7fe4dd"},{"_key":"9a1ed96927d7","markDefs":[],"children":[{"_type":"span","marks":[],"text":"I can speak to my perspective at a referral center that the vast majority of people with myeloma are receiving care in community settings. Oftentimes, when we get involved at a referral center, at an academic center, there's potentially a question about transplant eligibility, about eligibility for a BiTE [bispecific T-cell engager] or a CAR T cell. But just as often, these are referrals that are like grassroots referrals, and it's often an adult child who's driving care.It's not the patient who's maybe 75 or 80 years old, it's an adult child who's gotten on the internet, who's going to support groups, who's done his or her homework, and is saying, “Mom, I really think it's worth the drive to this center. Not that we are unhappy with our care, not that we disagree with our care, but this is a rare cancer. Maybe it would make sense to have somebody look at your case and meet you once, who does it for a living, who sees it every day.”","_key":"1350599e72c50"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"87957829728e0"}],"_type":"block","style":"normal","_key":"c81bbcef117c"},{"_type":"block","style":"normal","_key":"4194d4d05490","markDefs":[],"children":[{"text":"And I'm all about that. I think that's so important. Myeloma is a rare cancer, and I think the more that—the patient, obviously—but the patient's family, their loved ones, and most often it's the adult children—it's actually usually the oldest daughter for what it's worth, who's taking time off work, who's finding childcare, who's making sacrifices to make sure mom or dad is getting the best care possible. 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Despite advancements, ageism persists in treating older blood cancer patients, often excluding them from intensive therapies. City of Hope emphasizes equitable, value-based care, integrating supportive and integrative oncology to enhance patient well-being. Efforts to democratize cancer care include expanding access to comprehensive assessments and innovative therapies. Maintaining consistent, high-quality care across multiple sites remains a challenge, addressed through clinical trials, genomic testing, and standardized pathways.","authorMapping":[{"biography":[{"markDefs":[],"children":[{"text":"Mary Caffrey is the Executive Editor for The American Journal of Managed Care® (","_key":"9737335da1ed0","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"AJMC","_key":"b8dda18bb0dc"},{"_key":"f56917041c08","_type":"span","marks":[],"text":"®). She joined AJMC® in 2013 and is the primary staff editor for "},{"_type":"span","marks":["em"],"text":"Evidence-Based Oncology, ","_key":"8c710bb1d962"},{"marks":[],"text":"the multistakeholder publication that reaches 22,000+ oncology providers, policy makers and formulary decision makers. She is also part of the team that oversees speaker recruitment and panel preparations for ","_key":"1b94f48924f3","_type":"span"},{"_type":"span","marks":["em"],"text":"AJMC","_key":"3c5f9805f644"},{"_type":"span","marks":[],"text":"®'s premier annual oncology meeting, Patient-Centered Oncology Care®. For more than a decade, Mary has covered ASCO, ASH, ACC and other leading scientific meetings for ","_key":"d533ba55a862"},{"marks":["em"],"text":"AJMC","_key":"953d8c643cce","_type":"span"},{"marks":[],"text":" readers. ","_key":"182af2348b04","_type":"span"}],"_type":"block","style":"normal","_key":"80606b0b2412"},{"_key":"a03d32973d6e","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.linkedin.com/in/marykcaffrey/","_key":"4f88673cb2c4"}],"children":[{"_type":"span","marks":[],"text":"Mary has a BA in communications and philosophy from Loyola University New Orleans. You can connect with Mary on ","_key":"c2027cf5a357"},{"_type":"span","marks":["4f88673cb2c4"],"text":"LinkedIn","_key":"9737335da1ed1"},{"_key":"9737335da1ed2","_type":"span","marks":[],"text":"."}],"_type":"block","style":"normal"}],"_updatedAt":"2023-10-12T05:02:06Z","url":{"current":"mary-caffrey","_type":"slug"},"displayName":"Mary Caffrey","_createdAt":"2020-05-05T10:50:00Z","_rev":"fWre465xUeSiaQm83HJghZ","_type":"author","_id":"author_6732921f288a3775abb89da57903428b"}],"title":"Putting Patients First by Extending the Reach of World-Class Care","_rev":"HD8oYngDfccJkwfGHq64RY","contentCategory":{"_createdAt":"2020-04-03T20:03:53Z","_rev":"Q2ZL7ihdIB33NiMMcGccmh","_type":"contentCategory","name":"Articles","_id":"3f4b3ced-7c9d-4fc4-967f-fe993087cce2","_updatedAt":"2023-09-29T14:32:27Z"},"body":[{"children":[{"_key":"af7c154b33cf0","_type":"span","marks":[],"text":"To hear Joseph Alvarnas, MD, tell it, the fight against cancer was once seen as a mission to create increasingly powerful drugs—as much as the human body could handle—and pummel the disease into submission."}],"_type":"block","style":"normal","_key":"3c251ed2d040","markDefs":[]},{"_key":"ba2e1e8e4a5b","asset":{"_ref":"image-af52de9cf6567f57cf6bb462ab89a55b522fdb97-800x800-jpg","_type":"reference"},"disableLightBox":true,"widthP":25,"disableTextWrap":false,"imgcaption":[{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Joseph Alvarnas, MD | Image: City of Hope","_key":"b02ed301f7a5"}],"_type":"block","style":"normal","_key":"50e09e58209d"}],"_type":"figure","alignment":"left","alt":"Joseph Alvarnas, MD | Image: City of Hope"},{"_key":"e5b0924391f3","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“The paradigm for how oncology was going to evolve was based on finding a bigger hammer,” said Alvarnas, vice president for government affairs for City of Hope Comprehensive Cancer Center, a National Cancer Institute (NCI)–designated center based in Duarte, California, and chief clinical adviser for AccessHope.","_key":"09f70b886138"}],"_type":"block","style":"normal"},{"style":"normal","_key":"cc1d01cd7849","markDefs":[],"children":[{"text":"Eventually, the focus on toxic drugs pivoted to precision medicine, which showed how genetics drives cancer in individual patients and caused “all that hubris to come crashing down,” Alvarnas said. The results have been sharp drops in cancer mortality and improvements in patients’ quality of life.","_key":"9adafd814aab","_type":"span","marks":[]},{"_type":"span","marks":["superscript"],"text":"1","_key":"d921871c9bb6"}],"_type":"block"},{"style":"normal","_key":"0ace06f54fc3","markDefs":[],"children":[{"_key":"8c80693bde17","_type":"span","marks":[],"text":"But more can be done, said Alvarnas, who chaired the September 19, 2024, session of the Institute for Value-Based Medicine®, held in Garden Grove, California, with the theme, “Prioritizing the Patient in Value-Based Oncology Care.”"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Making care more patient-centered has caused City of Hope to look outward over the past decade, and Alvarnas shared ways the world-famous research and treatment center has brought this approach to a new academic center in Orange County, California, as well as sites in Gilbert, Arizona; Chicago, Illinois; and Atlanta, Georgia.","_key":"7f3adf9c1227"},{"_type":"span","marks":["superscript"],"text":"2","_key":"2972e0a2e9a1"}],"_type":"block","style":"normal","_key":"636ff5402645"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"There’s also AccessHope, which now reaches 7 million members through 400 employers, offering expertise on challenging cases wherever they may occur. Through AccessHope, City of Hope physicians provide expertise to local doctors to help keep patients close to home. Then, if necessary, patients come to a City of Hope facility for specialized care.","_key":"3016e3cb1715"},{"_key":"4847bd4e8545","_type":"span","marks":["superscript"],"text":"3"}],"_type":"block","style":"normal","_key":"b1a70d240750"},{"_key":"31e84c2331c4","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Clinical advances in cancer, Alvarnas said, have “evolved at such a breakneck pace that it’s impossible to keep up in so many ways.” The current challenges, he said, involve delivering care in an equitable way, by ensuring access to patients who are poor, are minorities, or live far from a comprehensive cancer center.","_key":"4149493dbc6d"}],"_type":"block","style":"normal"},{"_key":"7f36d77fd266","markDefs":[],"children":[{"text":"The push for value-based care can sometimes focus too heavily on what medications cost, at the expense of what is right for the patient, he said. Finding the right balance, he said, involves as follows:","_key":"6f1d065e4047","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Delivering precision medicine for each patient close to home,","_key":"cac3915dadf3"}],"level":1,"_type":"block","style":"normal","_key":"76316cf1679a","listItem":"bullet"},{"_key":"fd8558a84718","listItem":"bullet","markDefs":[],"children":[{"_key":"41880314d355","_type":"span","marks":[],"text":"Not treating oncology care as a “technological arms race,” but instead recognizing that “a cancer journey is a human journey,” and"}],"level":1,"_type":"block","style":"normal"},{"children":[{"text":"Integrating the other domains of oncology care, which includes communicating with the patient and the family in a way that is compassionate.\n","_key":"431a71450770","_type":"span","marks":[]}],"level":1,"_type":"block","style":"normal","_key":"584da5314fed","listItem":"bullet","markDefs":[]},{"_type":"block","style":"normal","_key":"88bdd280bc06","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Fighting Ageism in Treating Blood Cancers","_key":"de84915b305a"},{"_key":"01f647da4b1e","_type":"span","marks":[],"text":"\nIf cancer is a disease of aging, would it not make sense for older individuals would have access to the best care?"}]},{"alt":"Eileen P. Smith, MD | Image: City of Hope","imgcaption":[{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Eileen P. Smith, MD | Image: City of Hope","_key":"7f9f358fe0f7"}],"_type":"block","style":"normal","_key":"9af0d8ed4895"}],"_key":"797eff26d81f","disableLightBox":true,"asset":{"_ref":"image-3c285c535309c8750e66df9976a85be055ea281d-315x415-jpg","_type":"reference"},"disableTextWrap":false,"_type":"figure","widthP":25,"alignment":"left"},{"_type":"block","style":"normal","_key":"c23e3b71c7a6","markDefs":[],"children":[{"marks":[],"text":"Despite significant clinical advances in treating patients with blood cancers, ageism stubbornly lingers for individuals who receive a blood cancer diagnosis when they are older than 65 years, according to City of Hope’s Eileen P. Smith, MD, a professor and the Francis \u0026 Kathleen McNamara Distinguished Chair of the Department of Hematology and Hematopoietic Cell Transplantation.","_key":"c580d6bce052","_type":"span"}]},{"markDefs":[],"children":[{"_key":"6cdb77d7b140","_type":"span","marks":[],"text":"Smith highlighted data from the NCI’s Surveillance, Epidemiology, and End Results Program showing that 54% of new cancer diagnoses and 70% of cancer mortality occur among individuals older than 65 years."},{"_type":"span","marks":["superscript"],"text":"4","_key":"a56880442426"},{"marks":[],"text":" And yet, “older populations have been underrepresented in clinical trials of oncology,” and changing this is a priority for comprehensive cancer centers, she said.","_key":"65a59ddeb738","_type":"span"}],"_type":"block","style":"normal","_key":"53ab16dddbf7"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"“There has been a tendency for clinicians to not deliver care outside of the population that was defined as eligible in the clinical trials,” she said. “Older patients are less likely to even receive standard-of-care cancer therapy because often they are assessed as too fragile to undergo intensive care.”","_key":"cd0999bced84"}],"_type":"block","style":"normal","_key":"6413b0193201"},{"style":"normal","_key":"55f89dd4185c","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Decision-making may be affected by an older person’s functional, cognitive, or nutritional status; their level of psychosocial support; untreated depression; and most critically, polypharmacy, “which is something that adversely impacts the outcome for many older patients and really needs to be taken into consideration in planning for their cancer care,” Smith said.","_key":"6d674c241a09"}],"_type":"block"},{"_key":"4772972ea774","markDefs":[],"children":[{"text":"Clinical guidelines from multiple groups—such as the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), and the International Society of Geriatric Oncology—call for a comprehensive geriatric assessment for these patients to reveal challenges that can be managed. “Comprehensive cancer centers have been leading the way in these kinds of assessments,” Smith said.","_key":"082b2c51967f","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"children":[{"text":"In hematologic malignancies, she said, “the impact of aging ageism is very, very striking,” and City of Hope has worked to help patients who are not being referred for care.","_key":"2c9442014576","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"96d792bda619","markDefs":[]},{"children":[{"marks":[],"text":"One shocking statistic, Smith said, is that 40% of patients with acute myeloid leukemia (AML) “are never referred for intensive therapy.","_key":"d51441dcfcaf","_type":"span"},{"_type":"span","marks":["superscript"],"text":"5","_key":"a91e2c6e5504"},{"text":" They are directly referred for supportive care or palliative care.” Although allogeneic transplant offers the only curative modality for many patients with intermediate or high-risk acute leukemias, she said, “Older patients are routinely not referred for allogeneic transplant or referred late in the course of their illness, when they are no longer a candidate for transplant.”","_key":"e9619884814e","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"b7b3fd3193e1","markDefs":[]},{"_type":"block","style":"normal","_key":"247ec25200de","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Patients with AML who are older than 65 years and do not receive intensive therapy “have a less than 5% 5-year survival,","_key":"ab93c836c401"},{"_type":"span","marks":["superscript"],"text":"6","_key":"cd21899f0e89"},{"text":" and that is partly because many clinicians are still thinking in terms of the treatment paradigm that existed more than 10 years ago,” Smith said, referring to when anthracycline-based regimens were too difficult for older patients to tolerate.","_key":"85a378495afd","_type":"span","marks":[]}]},{"style":"normal","_key":"70ae83880e87","markDefs":[],"children":[{"marks":[],"text":"Today, she said, clinicians can use less-intensive, “hypomethylating agents and targeted therapies, which can be selectively used based on the molecular profile of the disease, that can very easily be used in an outpatient setting and around the community [for] these patients.”","_key":"0620b8d8e7c0","_type":"span"}],"_type":"block"},{"children":[{"marks":[],"text":"Smith noted that Andrew Saul Artz, MD, MS, professor in the Division of Leukemia and director of the Aging and Blood Cancers Program at City of Hope, runs a multidisciplinary team that completes a geriatric assessment to learn how older patients can receive prehabilitation to make them eligible for regimens that would otherwise be off-limits. Artz was coauthor of a 2021 paper that stated that older patients who have transplants have better long-term survival outcomes.","_key":"b80198e2d4b4","_type":"span"},{"_key":"0730f380eca2","_type":"span","marks":["superscript"],"text":"7"}],"_type":"block","style":"normal","_key":"fca7273fc4e9","markDefs":[]},{"markDefs":[],"children":[{"marks":[],"text":"“Study after study has shown this, and yet it still hasn’t changed the treatment paradigm in the community, where the assumption is that if you’re over 65 years old, you’re too old to have a transplant,” Smith said. “So the educational message that we’re trying to get out to our community sites is to refer your older patients early…so they can have a comprehensive geriatric assessment, and we can partner with our community physicians to find out what is the ideal treatment for that patient.”","_key":"0463a84fa943","_type":"span"}],"_type":"block","style":"normal","_key":"3d4c3a77abb6"},{"_type":"block","style":"normal","_key":"224bb8947736","markDefs":[],"children":[{"marks":[],"text":"In multiple myeloma, there have been similar challenges, she said, despite the fact that the disease now has FDA-approved bispecific therapies—teclistamab (Tecvayli) and talquetamab (Talvey)—as well as 2 chimeric antigen receptor (CAR) T-cell therapies, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti). The challenge is deciding the appropriate sequencing of these therapies vs an autologous transplant, she said, which calls for the expertise of a comprehensive cancer center.","_key":"c93fa13d38e3","_type":"span"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"City of Hope, Smith said, is bringing this expertise to the community by opening a center in Orange County, sparing patients a drive of more than 2 hours in busy traffic. And when doctors at City of Hope’s Chicago site performed the site’s first CAR T-cell procedure, Elizabeth L. Budde, MD, PhD, a City of Hope associate professor, flew to Chicago to be there for the patient. Budde is well-known not only for leading clinical trials but also for publishing on the process of developing a CAR T-cell program.","_key":"585598d58e4a"},{"_type":"span","marks":["superscript"],"text":"8","_key":"3de0eaa5a1d7"}],"_type":"block","style":"normal","_key":"395be21ddb20"},{"children":[{"_type":"span","marks":[],"text":"“The concept is to democratize cancer care by bringing the care to the community where the patient lives. And if we can do that by building cancer centers or by having virtual consults with individuals in the treatment centers where they live, that’s the way forward,” Smith said.\n\n","_key":"b04a7ded0388"},{"_type":"span","marks":["strong"],"text":"Supportive Care and Integrative Oncology","_key":"1e884992fd7c"},{"_key":"076e7952d02e","_type":"span","marks":[],"text":"\nAppointed chair of City of Hope’s Department of Supportive Care Medicine in April 2023,"},{"text":"9","_key":"524d54415030","_type":"span","marks":["superscript"]},{"_type":"span","marks":[],"text":" Andrew Leitner, MD, leads a team that was one of the first of its kind in recognizing supportive care as a specialty and developing models it shares across the world.","_key":"55983ebf8c5a"}],"_type":"block","style":"normal","_key":"ee7ceb72e9ff","markDefs":[]},{"disableLightBox":true,"_type":"figure","_key":"c6a997e9ebe7","disableTextWrap":false,"widthP":25,"imgcaption":[{"markDefs":[],"children":[{"marks":[],"text":"Andrew Leitner, MD | Image: City of Hope","_key":"41cf978b2b40","_type":"span"}],"_type":"block","style":"normal","_key":"b64063fd53d6"}],"asset":{"_ref":"image-daf59ca5cc16c823397414bcc9a1d40260c99b37-315x415-jpg","_type":"reference"},"crop":{"right":0,"top":0.04711258828417117,"left":0,"bottom":0.1169089088709363,"_type":"sanity.imageCrop"},"alt":"Andrew Leitner, MD | Image: City of Hope","hotspot":{"height":0.8359785028448925,"_type":"sanity.imageHotspot","width":1,"x":0.5,"y":0.46510183970661745},"alignment":"left"},{"children":[{"_key":"90d79dd1741d","_type":"span","marks":[],"text":"“One of the things we believe at City of Hope, and you can see it sort of manifest throughout our comprehensive cancer centers, is there are some fundamental things that all patients with a cancer diagnosis ought to have access to,” Leitner said. These include education about their condition, care coordination, and help with navigation, which CMS at long last is recognizing through reimbursement codes,"},{"_key":"3015a6c7ecbd","_type":"span","marks":["superscript"],"text":"10"},{"_type":"span","marks":[],"text":" although these need refinement, he said.","_key":"51532b06ea61"}],"_type":"block","style":"normal","_key":"d46032b83ca8","markDefs":[]},{"_key":"7fca5bd18b2c","markDefs":[],"children":[{"marks":[],"text":"Although supportive care focuses on quality of life, “The survival impact is also important,” he said, referencing a 2010 lung cancer study that showed how early supportive care could produce survival outcomes on par with some new drugs.11 “The field really was revolutionized,” he noted.","_key":"e67a0bcf755d","_type":"span"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"“Quality of life and survival need not be mutually exclusive,” Leitner said. “Patients who have better functional status and have a holistic approach to their care can do better on cancer-directed therapy, including in outcomes like survival. And then, of course, there are a number of unmet needs as patients are going through their cancer treatment journey. Supportive care is not just a collection of services, but really a treatment approach about how to address those needs.”","_key":"7afab85ccdb4"}],"_type":"block","style":"normal","_key":"90ddd5f313b1","markDefs":[]},{"children":[{"_type":"span","marks":[],"text":"The questions around supportive care have been whether it works and who pays for it, as the savings are seen in reducing health care utilization. Leitner reviewed results from multiple studies highlighting the value of supportive care, from Ma et al, which found early palliative care for adults with serious illness could reduce admissions to the intensive care unit (ICU) by 22% and reduce costs by 15%,","_key":"cb9bdb3b1364"},{"_type":"span","marks":["superscript"],"text":"12","_key":"a7e8659be980"},{"_type":"span","marks":[],"text":" to work by Ethan Basch, MD, which showed monitoring of patient self-reported symptoms improved outcomes,","_key":"59485e964d6c"},{"text":"13","_key":"4c694e19d410","_type":"span","marks":["superscript"]},{"_key":"c1c50b722a9f","_type":"span","marks":[],"text":" to those of the GAIN-S intervention presented by City of Hope’s William Dale, MD, PhD, at ASCO 2024, which brought a significant drop in grades 3 to 5 chemotherapy toxic effects without dose reductions or reductions in overall survival."},{"_type":"span","marks":["superscript"],"text":"14","_key":"1446457277ee"}],"_type":"block","style":"normal","_key":"a7540d6ca86d","markDefs":[]},{"_key":"11d4034765e6","markDefs":[],"children":[{"_type":"span","marks":[],"text":"A multipart supportive care framework at City of Hope features a 4-part assessment and initial delivery phase, followed by assessments and alignment with institutional goals. The key is acting early, Leitner said. “Patients don’t want to die in the hospital. Patients don’t want to be in the ICU unless there is a meaningful opportunity for recovery. And yet, too many patients are in the ICU, so an ability to intercept upstream of an ICU admission is very meaningful,” he said.","_key":"d4c5cd331bb5"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"82cb9e004b21","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Tailoring the amount and design of supportive care services to patient need is essential. “The most underutilized resource in all of health care is the patient, and the more we utilize the patient, the better we will do,” Leitner said.","_key":"9f359b43fa80"}]},{"children":[{"_type":"span","marks":[],"text":"Beyond supportive care, City of Hope has launched its Cherng Family Center for Integrative Oncology thanks to a $100 million gift from Andrew and Peggy, the founders of Panda Express.","_key":"47dc99be7c65"},{"_type":"span","marks":["superscript"],"text":"15","_key":"51785d5b750a"},{"text":" Richard T. Lee, MD, who is the program’s chair and medical director for Supportive \u0026 Integrative Medicine at City of Hope Orange County and the Departments of Supportive Care Medicine and Medical Oncology at City of Hope, outlined how the center is blending Eastern and Western approaches to develop a new standard of care involving integrative therapies to address pain, nausea, neuropathy, and other effects of cancer treatment.","_key":"5c2027626ba8","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"18a2e9fd037d","markDefs":[]},{"_type":"block","style":"normal","_key":"a67cb96e762f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Lee explained there are many ways that physicians think about integrative, complementary, and alternative medicine (ICAM), but the most important feature at City of Hope is that it is evidence-based. This helps Lee keep patients who are interested in alternative therapies from trying things that could be ineffective or even harmful.","_key":"124defed5864"}]},{"style":"normal","_key":"8755a6aa8204","markDefs":[],"children":[{"marks":[],"text":"“When I tell my colleagues I do integrative oncology, I get a lot of funny looks, but my patients bring me all sorts of reading materials on how they can cure themselves of cancer,” he said. “And I agree, unfortunately, in the field, there’s a lot of variability.”","_key":"bf0c3902dada","_type":"span"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"The field includes natural products such as shark cartilage, herbs, and supplements; mind-body interventions such as meditation; body-based approaches such as massage, chiropractic, and osteopathic manipulation—“and then they kind of catch all of the other whole medical systems, like traditional Chinese medicine, Ayurvedic energy therapies, and other categories,” he said.","_key":"76b5415ae508"}],"_type":"block","style":"normal","_key":"a9f9e1af4568","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"More than 100 institutions now have integrative medicine programs, and City of Hope has joined a consortium to discuss reaffirming the practice, what Lee called “thinking about the whole person.”","_key":"66104240337d"}],"_type":"block","style":"normal","_key":"faf8274c2cc9"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"“What separates integrative medicine from what I would consider complementary or alternative medicine is that it has to be evidence-based. It has to be appropriate. So not everything out there is appropriate for every patient, and that is, I would say, entirely true when we think about cancer care,” he said.","_key":"204a8021345d"}],"_type":"block","style":"normal","_key":"2e67be1597f5"},{"_type":"block","style":"normal","_key":"010271302566","markDefs":[],"children":[{"text":"The approaches are very popular with patients, both at City of Hope and elsewhere. Surveys from the CDC starting in 2012 showed that at least one-third of patients had used some type of ICAM approach in the prior 12 months, and data Lee shared from The University of Texas MD Anderson Cancer Center showed that 50% of patients were using an ICAM therapy and 75% had heard of them. Often, Lee said, the problem is that patients don’t tell their physicians that they are using supplements or other ICAM treatments.","_key":"71f3662ee932","_type":"span","marks":[]}]},{"_key":"8cd4532dd78e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Another challenge is that ICAM approaches are often available only at a main campus, which City of Hope is trying to address by having services at both Duarte and Orange County. Lee said the infrastructure is being equipped to handle research at multiple sites, and City of Hope wants to offer fellowships and training for more integrative oncologists.","_key":"ae1f0875058d"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Lee explained how integrative oncology complements supportive care. “They’re both focused on a holistic approach, focusing on improving quality of life, and managing symptoms,” he said, but integrative oncology takes an additional step toward optimizing well-being.","_key":"7c90ee1a13f1"}],"_type":"block","style":"normal","_key":"50f0b9a7d847"},{"markDefs":[],"children":[{"text":"“When I was in my early career, I would send people to physical therapy, and they would say, ‘Oh, they can do their activities of daily living.’ But I would say, ‘Well, are they actually meeting the American Cancer Society guidelines on exercise? Are they exercising 150 minutes a week?’ Because we know that it can reduce certain types of cancer. So we really want to go the extra step, and we are interested in anticancer properties of natural products as well as those that could help with symptoms,” Lee said.","_key":"d469d2b62afc","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"48db532c28b5"},{"_key":"ad87c5ca3a99","markDefs":[],"children":[{"_type":"span","marks":[],"text":"He added, “But can we discover new therapies through plants? And I think there’s opportunity there. We have the patient at the center with their family, their culture, their background, that they bring together. We have the great modern therapies that City of Hope has pioneered, from stem cell transplant and immunotherapy CAR T, but we want to surround that with all the right supportive care services. We have great supportive care programs already, and integrative oncology brings in more options and therapies in the different dimensions of health, [such as] integrative medicine consultation, acupuncture, massage, music, art therapy, yoga, meditation group programs, and healing spaces.”","_key":"2910cb78a307"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_key":"a3420d1dd1e9","_type":"span","marks":[],"text":"Lee went through a roster of services offered at both locations, including oncology massage, which helps patients experiencing anxiety about receiving therapy. He also counsels patients who show up with a dozen different herbs and gets them to focus on whether the supplements will really help or cause a drug-drug interaction. Lee works with patients to guide them to treatments for anxiety or depression that meet NCCN guidelines or those of the Society for Integrative Oncology."}],"_type":"block","style":"normal","_key":"b05355f04e4e"},{"_key":"21ddbf600bbf","markDefs":[],"children":[{"_key":"8b078c8cfc8a","_type":"span","marks":[],"text":"“I had a patient who has metastatic breast cancer and was thinking about chemotherapy, but ultimately she really wanted a more holistic approach,” Lee said. After a discussion, the patient agreed to connect with a breast cancer oncologist and start chemotherapy while Lee worked on other integrative therapies."}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_key":"59945b2df34b","_type":"span","marks":[],"text":"“And I said, that’s exactly what we want to do, rather than her going [to another country for treatment] and doing things that just aren’t safe and aren’t going to help her,” he said.\n\n"},{"_key":"aa35cd0466d3","_type":"span","marks":["strong"],"text":"Keeping Care Consistent Across Multiple Sites"},{"_type":"span","marks":[],"text":"\nProviding world-class cancer care is not easy. Providing the same world-class care at every site across a vast network is an even bigger challenge, which Linda Bosserman, MD, FASCO, FACP, addressed.","_key":"092000a7c972"}],"_type":"block","style":"normal","_key":"a15fa1c894e4"},{"alt":"Linda Bosserman, MD, FASCO, FACP | Image: City of Hope","imgcaption":[{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Linda Bosserman, MD, FASCO, FACP | Image: City of Hope","_key":"a29a0b7a43d7"}],"_type":"block","style":"normal","_key":"d3b24d475afd"}],"widthP":25,"_type":"figure","hotspot":{"x":0.48177099227905273,"y":0.5,"height":1,"_type":"sanity.imageHotspot","width":0.8802080154418945},"disableLightBox":true,"_key":"a898cad619a2","alignment":"left","asset":{"_ref":"image-4b4515033483c63d04ba72fd995a7a7c8febe154-256x256-jpg","_type":"reference"},"crop":{"right":0.078125,"top":0,"left":0.04166698455810547,"bottom":0,"_type":"sanity.imageCrop"},"disableTextWrap":false},{"style":"normal","_key":"c52e7507a97f","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Bosserman, a professor of medical oncology and therapeutics research, also is medical director for value-based care and for the Center for International Medicine. She explained that City of Hope now has more than 600 physicians at 40 sites, including 34 in California. Through partnerships, Bosserman said, City of Hope’s reach spans the globe.","_key":"6ef052d62ad6"}],"_type":"block"},{"_key":"e04bff1a145a","markDefs":[],"children":[{"_type":"span","marks":[],"text":"“I spent a week teaching [about] breast cancer in China, seeing patients, working with doctors, and talking about standards and treatment,” she said. “We have a partnership with Brazil, the No. 1 cancer center in Latin America. We just signed an agreement with doctors in the Philippines who have come over. We exchanged fellows and physicians and training. We work on genomic programs and cellular therapies. Our hematologists work together. We have tumor boards jointly with these programs to share…our expertise with people all over the world, not just throughout the United States.”","_key":"80d6e730c853"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"text":"How does City of Hope ensure high-level care across its many sites and partnerships? Bosserman outlined the elements as follows:","_key":"29ee8a44e782","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"dcd85104ed96"},{"_type":"block","style":"normal","_key":"f519fa9c70cd","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Clinical trials.","_key":"5503f45dee4f"},{"text":" Trials ensure access to the best care, and they save money, she said. “Clinical trials provide the experimental treatments at no cost—and these run $100,000 or $200,000 for our cellular therapies. Those are provided at no cost when you’re on that arm of a trial or an oral therapy, while the standard arm is paid for by your insurance.” However, she noted that trials are labor intensive and require their own staff.","_key":"66a83405e375","_type":"span","marks":[]}]},{"_key":"edc16527ad5a","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Genomic testing","_key":"612463d757d6"},{"_type":"span","marks":[],"text":". Getting patients to the center requires that they receive the right diagnosis, she said, “and, increasingly, that means genomic testing.” Bosserman emphasized that it’s essential to have not only access to testing but also an infrastructure to read the results and get information back out to physicians quickly.","_key":"6bcc0445e60c"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Clinical pathways","_key":"5a5b1e61c5fd"},{"_type":"span","marks":[],"text":". Bosserman described the layout of City of Hope’s EPIC medical records system and data collection tools, which allow clinicians to see the first, second, and third choices for treatment, along with clinical trial options and where trials are being offered. Using these electronic tools ensures “that all patients’ needs are considered when we order a plan—we don’t just order drugs,” she said.","_key":"65bd350f649d"}],"_type":"block","style":"normal","_key":"360a73e3896d"},{"markDefs":[],"children":[{"text":"City of Hope’s pathways are consistent from site to site, and the network also uses patient-reported outcome tools to track symptoms and social determinants of health, and guide treatment based on a patient’s goals of care. Beyond the pathways, Bosserman said, City of Hope faculty are very connected in their work processes, through tumor boards, and even via informal means. City of Hope faculty are also involved in creating national guidelines.","_key":"defc393fb817","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"69d181ef80cb"},{"markDefs":[],"children":[{"_key":"23b6611adb93","_type":"span","marks":[],"text":"All this pays off. Bosserman shared data for City of Hope across sites that show that in patients between stage I and III disease, City of Hope had a 93% to 97% 5-year survival rate, and if breast cancer was diagnosed at stage IV, the 5-year rate was 78%."}],"_type":"block","style":"normal","_key":"aca83473841d"},{"markDefs":[],"children":[{"_key":"fd4c2d853689","_type":"span","marks":[],"text":"The faculty examine outcomes by biomarker to find areas where they can improve, she said. “We challenge ourselves when we see something we might do better. We know how to delve into it and how to restructure our programs and our approaches and our trials for continued improvements,” Bosserman said."}],"_type":"block","style":"normal","_key":"5fb9975a6479"},{"children":[{"marks":[],"text":"“This is happening in all of our tumor types, and it’s something we’re really proud of—the systems we’re putting in place give us information to show that we’re doing better,” she said. “It’s based on these very comprehensive approaches. This is really what we are.” \n\n","_key":"1b0e41299aba","_type":"span"},{"_type":"span","marks":["strong"],"text":"References","_key":"b6542e1d219c"},{"text":"\n1. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA: Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820\n2. City of Hope. Our cancer centers. Accessed October 23, 2024. https://www.cityofhope.org/\n3. AccessHope. Accessed October 23, 2024. https://www.myaccesshope.org/\n4. Cancer stat facts: cancer at any site. National Cancer Institute. Accessed October 23, 2024. https://seer.cancer.gov/statfacts/html/all.html\n5. Loh KP, Abdallah M, Kadambi S, et al. Treatment decision-making in acute myeloid leukemia: a qualitative study of older adults and community oncologists. Leuk Lymphoma. 2020;62(2):387-398. doi:10.1080/10428194.2020.1832662\n6. Thein MS, Ershler WB, Jemal A, Yates JW, Baer MR. Outcome of older patients with acute myeloid leukemia: an analysis of SEER data over three decades. Cancer. 2013;119(15):2720-2727. doi:10.1002/cncr.28129\n7. Lin RS, Artz AS. Allogeneic hematopoietic cell transplantation for older patients. Hematology Am Soc Hematol Educ Program. 2021;2021(1):254-263. doi:10.1182/hematology.2021000257\n8. Dulan SO, Viers KL, Wagner JR, et al. Developing and monitoring a standard-of-care chimeric antigen receptor (CAR) T cell clinical quality and regulatory program. Biol Blookd Marrow Tranplant. 2020;26(8):1386-1393. doi:10.1016/j.bbmt.2020.03.021\n7. Marquez L. Andrew L. Leitner MD appointed chair of City of Hope Department of Supportive Care Medicine. News release. City of Hope. April 17, 2023. Accessed October 23, 2024. https://www.cityofhope.org/andrew-t-leitner-md-appointed-chair-of-city-of-hope-department-of-supportive-care-medicine\n10. CMS-1784-F. CMS. November 16, 2023. Accessed January 19, 2024. https://www.cms.gov/medicare/medicare-fee-service-payment/physicianfeesched/pfs-federal-regulation-notices/cms-1784-f\n11. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363(8):733-742. doi:10.1056/NEJMoa1000678\n12. Ma J, Chi S, Buettner B, et al. Early palliative care consultation in the medical ICU: a cluster randomized crossover trial. Crit Care Med. 2019;47(12):1707-1715. doi:10.1097/CCM.0000000000004016\n13. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318(2):197-198. doi:10.1001/jama.2017.7156\n14. Phillips T, Sun CL, Chien LC, et al. Geriatric assessment–directed supportive care intervention (GAIN-S)-implementation via telehealth in a lower-resourced community. Presented at: ASCO 2024; May 31-June 4, 2024; Chicago, IL. Abstract 1510. https://www.citedrive.com/en/discovery/geriatric-assessment-directed-supportive-care-intervention-gain-s-implementation-via-telehealth-in-a-lower-resourced-community/\n15. Logsdon Z. City of Hope receives $100 million gift to create first of its first-of-its-kind national integrative oncology program. News release. City of Hope. September 12, 2023. 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The primary efficacy end points were overall response rate (ORR) and duration of response (DOR). Of 164 previously untreated patients, the ORR was 57% (95% CI, 49%-65%), and 40% of responders had a DOR of at least 12 months. Of 149 previously treated patients, the ORR was 45% (95% CI, 37%-53%), and 36% of responders had a DOR of at least 12 months."}],"_type":"block"},{"children":[{"marks":[],"text":"","_key":"ae94c3a7aa3c","_type":"span"}],"_type":"block","style":"normal","_key":"9d6d44317836","markDefs":[]},{"style":"normal","_key":"2941dcf267fb","markDefs":[],"children":[{"_type":"span","marks":[],"text":"EQ-5D-5L Visual Analogue Scale and EORTC Core Quality of Life (QOL) Global Health Status questionnaire responses demonstrated stability in overall health-related QOL outcomes over time. EORTC QLQ-LC13 symptom scores for dyspnea and chest pain remained stable, and these scores for cough had a clinically meaningful improvement.","_key":"6e51f1734aba0"}],"_type":"block"},{"_type":"block","style":"normal","_key":"1db056d72ee9","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"cc2bf24cf633"}]},{"_key":"d8a629dd1c57","markDefs":[],"children":[{"_key":"54a2654ae74a0","_type":"span","marks":[],"text":"A pooled safety population included 448 patients with solid tumors enrolled across 5 open-label, single-arm trials in which they received tepotinib monotherapy at the recommended dose."},{"_key":"1b70001faea5","_type":"span","marks":["superscript"],"text":"4"},{"_type":"span","marks":[],"text":" This population included 255 patients from the VISION trial. In the VISION safety population, 45% of patients had serious adverse effects (AEs), the most common being pleural effusion (7%), pneumonia (5%), dyspnea (3.9%), edema (3.9%), general health deterioration (3.5%), musculoskeletal pain (2%), and pulmonary embolism (2%). One patient each died due to pneumonitis, hepatic failure, and dyspnea from fluid overload. The most common AEs included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.","_key":"e335a77a70d0"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"a87d9184da86","markDefs":[],"children":[{"text":"","_key":"b7e036417b94","_type":"span","marks":[]}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Further long-term efficacy findings showed that the median progression-free survival (PFS) in the treatment-naive cohort was 12.6 (95% CI, 9.7-17.7) months; the 12- and 24-month PFS rates were 52% (95% CI, 43.0%-60.0%) and 38% (95% CI, 29.0%-47.0%), respectively.","_key":"295640b9ab1d0"},{"_type":"span","marks":["superscript"],"text":"5","_key":"51a3536edb65"},{"_type":"span","marks":[],"text":" The median PFS in the previously treated cohort was 15.9 (95% CI, 11.0-49.7)months; the respective 12- and 24-month PFS rates were 59% (95% CI, 48.0%-69.0%) and 42% (95% CI, 30.0%-53.0%).","_key":"b413749ef057"}],"_type":"block","style":"normal","_key":"6d78c9f09c0e"},{"children":[{"_type":"span","marks":[],"text":"","_key":"1304c45858e2"}],"_type":"block","style":"normal","_key":"26687a426e7e","markDefs":[]},{"markDefs":[],"children":[{"marks":[],"text":"In the treatment-naïve and previously treated populations, the median overall survivals were 21.3 (95% CI, 14.2-25.9) months and 29.7 (18.8-not evaluable) months, respectively.","_key":"09a4be3a762b0","_type":"span"}],"_type":"block","style":"normal","_key":"c3bc7d360978"},{"_type":"block","style":"normal","_key":"f67fd83ab598","markDefs":[],"children":[{"text":"","_key":"9547fda13710","_type":"span","marks":[]}]},{"style":"normal","_key":"2c62af72507c","markDefs":[{"nofollow":true,"blank":true,"_type":"link","href":"https://www.foundationmedicine.com/press-release/fda-approval-foundationone-liquid-cdx-tepmetko","_key":"6f6daf60a940"}],"children":[{"_type":"span","marks":[],"text":"“Targeted therapies have led a revolution to how lung cancer is treated,” ","_key":"da2296bc77230"},{"_type":"span","marks":["6f6daf60a940"],"text":"said","_key":"f24315937ba6"},{"_key":"4beaca2d4d9a","_type":"span","marks":[],"text":" Laurie Ambrose, president and CEO of GO2 for Lung Cancer."},{"_type":"span","marks":["superscript"],"text":"1","_key":"b7566f9b3abc"},{"text":" “Biomarker testing plays a crucial part in getting these treatments into the hands of patients. 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News release. Foundation Medicine. November 18, 2024. Accessed November 18, 2024. ","_key":"9ca384f32c110"},{"_type":"span","marks":["0b0dfb97a9ba"],"text":"https://www.foundationmedicine.com/press-release/fda-approval-foundationone-liquid-cdx-tepmetko","_key":"1514c78708da"}],"_type":"block"},{"style":"normal","_key":"738842a55219","markDefs":[{"_type":"link","href":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tepotinib-metastatic-non-small-cell-lung-cancer","_key":"793005643d22","nofollow":true,"blank":true}],"children":[{"_type":"span","marks":[],"text":"2. FDA approves tepotinib for metastatic non-small cell lung cancer. News release. FDA. February 15, 2024. Accessed November 18, 2024. ","_key":"a8202d9b817d"},{"_type":"span","marks":["793005643d22"],"text":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tepotinib-metastatic-non-small-cell-lung-cancer","_key":"6c5fd11290ae"}],"_type":"block"},{"markDefs":[{"_key":"62b66f3970c7","nofollow":true,"blank":true,"_type":"link","href":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tepotinib-metastatic-non-small-cell-lung-cancer"}],"children":[{"marks":[],"text":"3. FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer. News release. FDA. February 3, 2021. Accessed November 18, 2024. ","_key":"96b40c42f442","_type":"span"},{"_type":"span","marks":["62b66f3970c7"],"text":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tepotinib-metastatic-non-small-cell-lung-cancer","_key":"84a976bac23d"}],"_type":"block","style":"normal","_key":"ee650d780d64"},{"_type":"block","style":"normal","_key":"a58137fd8266","markDefs":[{"href":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214096s001s002lbl.pdf","_key":"2f73b80abe61","nofollow":true,"blank":true,"_type":"link"}],"children":[{"_type":"span","marks":[],"text":"4. Tepmetko. Prescribing information. EMD Serono; 2023. Accessed November 18, 2024. ","_key":"bddf8e34e83a"},{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214096s001s002lbl.pdf","_key":"caea29a9270e","_type":"span","marks":["2f73b80abe61"]}]},{"_type":"block","style":"normal","_key":"273df9e85940","markDefs":[],"children":[{"_type":"span","marks":[],"text":"5. 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New data from the FINEARTS-HF trial, which evaluated the safety and efficacy of finerenone (Kerendia), offers some relief in this respect due to its large inclusion of female patients. Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) that has gained traction as a ","_key":"361b9d186ec10"},{"_type":"span","marks":["ac599e0f156b"],"text":"new therapeutic","_key":"361b9d186ec11"},{"_type":"span","marks":[],"text":" for patients with cardiorenalmetabolic diseases.","_key":"361b9d186ec12"}],"_type":"block"},{"markDefs":[],"children":[{"_key":"0eaefa1a143a0","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"ebd4acb48ef2"},{"markDefs":[{"_type":"link","href":"https://www.ajmc.com/conference/aha","_key":"8e0b7900f78f"}],"children":[{"_type":"span","marks":[],"text":"Misato Chimura, MD, PhD, University of Glasgow, presented on some of the latest, sex-specific findings from FINEARTS-HF at the 2024 ","_key":"ffcd41401e540"},{"_type":"span","marks":["8e0b7900f78f"],"text":"American Heart Association","_key":"ffcd41401e541"},{"_type":"span","marks":[],"text":" (AHA) conference. Overall, the study participation consisted of 46% females (n = 2732 vs 3269 males), which Chimura proudly stated, “makes it one of the few cardiovascular trials with a substantial representation of women.”","_key":"ffcd41401e542"}],"_type":"block","style":"normal","_key":"a47e97298532"},{"style":"normal","_key":"b22c0e518063","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"0822dd04487f0"}],"_type":"block"},{"_key":"2e26571b8cf6","markDefs":[],"children":[{"_type":"span","marks":["em"],"text":"This transcript has been lightly edited for clarity and length.","_key":"8b4c82f653e20"}],"_type":"block","style":"normal"},{"_key":"d3a7ee1e8919","markDefs":[],"children":[{"text":"","_key":"b262f28708230","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"style":"normal","_key":"181aa2f7414e","markDefs":[],"children":[{"_key":"97e2cf8371220","_type":"span","marks":["strong","underline"],"text":"Transcript"}],"_type":"block"},{"_type":"block","style":"normal","_key":"16c2353be502","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"bd5e8e2660220"}]},{"_key":"675e2aa676eb","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"What kind of questions did you examine in your sex-specific analysis? What results surprised you?","_key":"1205b4cd46600"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_key":"464e262506f70","_type":"span","marks":[],"text":""}],"_type":"block","style":"normal","_key":"0995d80dbece"},{"_type":"block","style":"normal","_key":"c21c5c01395e","markDefs":[],"children":[{"_type":"span","marks":[],"text":"I think that’s a very important question. In this study, we examined the efficacy and safety of finerenone in both women and men. Compared to placebo, finerenone similarly reduced the risk of the primary end point in both women and men, and consistent effects were observed for total heart failure events, first heart failure event, cardiovascular disease, and all-cause mortality. And the test for grade 6 treatment interaction was not significant for each outcome.","_key":"11daf12d1af10"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"e052f3fc36920"}],"_type":"block","style":"normal","_key":"2fb4394aebca"},{"children":[{"_type":"span","marks":[],"text":"For adverse events, finerenone increased the risk of hyperkalemia and hypertension and reduced the risk of hypokalemia compared with placebo, with similar effect in both women and men. And potential antiandrogen adverse events were rare between women and men and their treatment groups, and with no difference between placebo and treatment group.","_key":"76aa3fdc261a0"}],"_type":"block","style":"normal","_key":"eb572d5ab41b","markDefs":[]},{"style":"normal","_key":"84a973f65ad0","markDefs":[],"children":[{"_key":"17d2c539bc9d0","_type":"span","marks":[],"text":""}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Did your findings shed any light on the relationship between obesity and HFpEF? If so, what differences did you see between men and women?","_key":"c5e6911f00990"}],"_type":"block","style":"normal","_key":"da020e665dd3"},{"_key":"92e84f5405a5","markDefs":[],"children":[{"text":"","_key":"2dffc269ea1a0","_type":"span","marks":[]}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"We do not have a clear answer now, but in my impression, MRA is more effective in patients with obesity, but there is no difference between the sexes in the effect of finenerone in patients with obesity. Because obesity is associated with the excessive aldosterone secretion from adipocytes, independent of the classical renin-angiotensin-aldosterone system. So therefore MRA is more effective in the patient with obesity.","_key":"d4adf71200010"}],"_type":"block","style":"normal","_key":"dfbbf0f38864"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"But we believe that there are no reported differences in the metabolism of MRA between women and men. So currently, the substudy analysis of obesity is conducted, and once this data is available, we can get more information about this.","_key":"6f5442f3ca93"}],"_type":"block","style":"normal","_key":"050f955f1ff1"},{"children":[{"text":"","_key":"75efc5a8cb780","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"dbdaf2cd3543","markDefs":[]},{"children":[{"marks":["strong"],"text":"Finerenone is a nonsteroidal MRA, which should be safer for the kidneys than a steroidal MRA. Is this aspect of finerenone especially important to men or women?","_key":"015564e58eaf0","_type":"span"}],"_type":"block","style":"normal","_key":"48f575a97718","markDefs":[]},{"style":"normal","_key":"e458be332e25","markDefs":[],"children":[{"_type":"span","marks":[],"text":"","_key":"c49eb2db38af0"}],"_type":"block"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Well, the answer would be no, because, you know, the differences in anatomy, such as BSA [body surface area] and organ sites, as well as the differences in the pharmacokinetics and the pharmacodynamics are observed between women and men. But as I said, we believe that there are no notable differences in metabolism or MRA. 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