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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">News</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="2024-11-18T20:52:00.000">November 18, 2024</time></div><h1 class="text-[26px] font-medium leading-8">KRAKEN: Oral Muvalaplin Safely Lowers Lp(a) in Early-Stage Trial</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/mary-caffrey">Mary Caffrey</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="KRAKEN: Oral Muvalaplin Safely Lowers Lp(a) in Early-Stage Trial" 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" 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class="mt-6"><span class="text-primary text-sm">Conference</span><span class="mx-1 text-sm">|</span><span class="text-sm text-blue-700 underline">AHA: American Heart Association Scientific Sessions</span></div></a></div></div><div class="w-full flex flex-col px-4 py-4 border-t border-b border-solid border-gray-400 my-4 "><h3 class="text-primary text-xl font-semibold">Key Takeaways</h3><ul class="list-disc px-8"><li class="py-2 "> Muvalaplin, an oral drug, significantly reduces Lp(a) levels by disrupting apo(a) and apoB bonding, achieving up to 85.5% reduction in a phase 2 study. </li><li class="py-2 "> Lp(a) is a genetically driven cardiovascular risk factor with no current treatments, affecting 1 in 5 people globally. </li><li class="py-2 hidden"> Muvalaplin also reduces oxidized phospholipids, with no increase in adverse events compared to placebo, offering a non-injection alternative. </li><li class="py-2 hidden"> Other Lp(a) therapies in development include pelacarsen and olpasiran, with phase 3 trials expected to complete in 2025 and 2027, respectively.</li></ul><span class="text-xs font-bold text-primary underline cursor-pointer mt-2 ml-4">SHOW MORE</span></div><p class="py-2 mb-2 text-sm italic text-gray-600">Results bring more competition to treat this genetically driven target for cardiovascular risk.</p><div class="py-2"><div class="blockText_blockContent__TbCXh"><p class="pb-2">Competition is already heating up in a drug class where therapies are not yet approved, as findings for the first oral drug to lower lipoprotein(a) (Lp[a]) showed promise in a presentation today at the 2024 <a target="_blank" href="https://www.ajmc.com/view/kraken-oral-muvalaplin-safely-lowers-lp-a-in-early-stage-trial">American Heart Association (AHA) Scientific Sessions</a>, which drew to a close in Chicago, Illinois.</p><div class=""><div style="width:25%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:" class=" figure"><div class="flex-none relative text-center"><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=%27500%27%20height=%27500%27/%3e"/></span><img alt="Stephen Nicholls, MBBS, PhD | Image credit: Cardiology Society of Australia" title="Stephen Nicholls, MBBS, PhD | Image credit: Cardiology Society of Australia" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" 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%;object-fit:contain"/><noscript><img alt="Stephen Nicholls, MBBS, PhD | Image credit: Cardiology Society of Australia" title="Stephen Nicholls, MBBS, PhD | Image credit: Cardiology Society of Australia" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2Fc19314733069c049cbaed91a302836223aa7d1eb-500x500.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2Fc19314733069c049cbaed91a302836223aa7d1eb-500x500.png%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2Fc19314733069c049cbaed91a302836223aa7d1eb-500x500.png%3Ffit%3Dcrop%26auto%3Dformat&w=1080&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%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2">Stephen Nicholls, MBBS, PhD | Image credit: Cardiology Society of Australia</p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/ajmc/c19314733069c049cbaed91a302836223aa7d1eb-500x500.png?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">In a phase 2 study, muvalaplin was found to significantly reduce Lp(a) using both the traditional test for measuring these particles in the blood, and a new test that more accurately assesses how muvalaplin works to disrupt them, according to lead study author Stephen Nicholls, MBBS, PhD, director of the Victorian Heart Institute at Monash University in Melbourne, Australia.</p><p class="pb-2">Lp(a) is a genetically driven variant of low-density lipoprotein (LDL) cholesterol, that is known to be an independent risk factor for cardiovascular disease (CVD) and currently has no approved treatments. As commenter Erin D. Michos, MD, MHS, of Johns Hopkins noted at a press briefing, Lp(a) affects about 1 in 5 people worldwide.</p><div class=""><div style="width:25%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:" class=" figure"><div class="flex-none relative text-center"><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=%27293%27%20height=%27293%27/%3e"/></span><img alt="Erin D. Michos, MD, MHS | Image credit: Johns Hopkins" title="Erin D. Michos, MD, MHS | Image credit: Johns Hopkins" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" 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%;object-fit:contain"/><noscript><img alt="Erin D. Michos, MD, MHS | Image credit: Johns Hopkins" title="Erin D. Michos, MD, MHS | Image credit: Johns Hopkins" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F49789b49f6b5f4766e09e6018b26dbed894a5aa5-293x293.webp%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F49789b49f6b5f4766e09e6018b26dbed894a5aa5-293x293.webp%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fajmc%2F49789b49f6b5f4766e09e6018b26dbed894a5aa5-293x293.webp%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%;object-fit:contain" loading="lazy"/></noscript></span></div><div id="image-caption" class="text-gray-500 italic"><div class="blockText_blockContent__TbCXh"><p class="pb-2">Erin D. Michos, MD, MHS | Image credit: Johns Hopkins</p></div></div><div class="top-[-100%] block w-[1px] transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden"><img class="m-auto absolute inset-0 max-w-[0%] max-h-[0%] border-[3px] border-solid border-white shadow-[0px_0px_8px_rgba(0,0,0,0.3)] box-border transition ease-in-out duration-500" src="https://cdn.sanity.io/images/0vv8moc6/ajmc/49789b49f6b5f4766e09e6018b26dbed894a5aa5-293x293.webp?fit=crop&auto=format"/></div></div><style> #image-caption p{ font-size: 12px; max-width: 525px; margin: 0 auto; text-align: center; } </style></div><p class="pb-2">The 2 major protein components of Lp(a) are apolipoprotein(a), or Apo(a), associated with high-density lipoprotein or “good” cholesterol and apolipoprotein(b), or ApoB, associated with LDL or “bad” cholesterol. Muvalaplin works, Nicholls explained at the press briefing, by disrupting the bonding of apo(a) to apoB, which does not allow Lp(a) to form.</p><p class="pb-2">The study examined 3 different doses, at 10 mg, 60 mg, and 240 mg vs placebo over 12 weeks. To enroll, patients had to have serum level Lp(a) of at least 175 mmol/L.</p><p class="pb-2">In addition, the study team measured how well muvalaplin reduced oxidized phospholipids; Nicholls explained that Lp(a) acts as a “reservoir” for oxidized phospholipids, and “there is a school of thought that this is plays a particular mechanistic role in driving the relationship between Lp(a) and atherosclerotic disease.”</p><p class="pb-2">Results showed the study drug significantly reduced oxidized phospholipids as well, he demonstrated. Detailed results showed:</p><ul class="my-2"><li class="list-disc ml-8">In the traditional blood test, muvalaplin reduced Lp(a) by 70% compared with placebo, and it reduced Lp(a) by 85.5% in a new test that evaluates “intact” Lp(a) particles, accounting for those particles that might attach to the drug, Nicholls explained.</li><li class="list-disc ml-8">Treatment with muvalaplin helped 97% of participants to bring Lp(a) levels below 125 nmol/L, as measured by the intact Lp(a) particle test, or about 82% of what they measured with the traditional blood test.</li><li class="list-disc ml-8">Compared with placebo, muvalaplin lowered ApoB by as much as 16% with no change in high-sensitivity C-reactive protein, which would have indicated heart attack or stroke risk.</li><li class="list-disc ml-8">The percentage of serious adverse events was about the same in the placebo arm (6%) as the 10 mg arm (5.9%) , and the percentages were lower in the other arms, with 60 mg at 3.2% and 240 mg at 2.9%.</li></ul><p class="pb-2">Muvalaplin, being developed by Eli Lilly, is the latest of the therapies targeting Lp(a) to generate interest at recent cardiology conferences, but the first that would not require injection. Nicholls said these data follow up on previously reported phase 1 results, which showed a reduction of 65% for muvalaplin compared with placebo using the traditional blood test and <a rel="nofollow" target="_self" href="https://jamanetwork.com/journals/jama/fullarticle/2808864">were reported in <em>JAMA</em></a> in 2023.</p><p class="pb-2">Nicholls emphasized that Lp(a) is a distinct, independent risk factor from others that might be treated by primary care physicians and cardiologists; current recommendations call for adults to be tested at least once in their lifetime to learn whether they have elevated levels. But Michos said right now, even when clinicians know a patient has high Lp(a) there is only so much they can do.</p><p class="pb-2">“Our current approach is to take an account to both the patient's global cardiovascular risk—so their other risk—as well as their absolute lipoprotein(a) level.”</p><p class="pb-2">By contrast, when treating LDL cholesterol, although there are certain thresholds between intermediate and high risk, she said, “it’s really a continuous threshold,” and “we try to treat all their risk factors the best we can, get their LDL as low as possible. But the reason why this is so important is that even in patients who are treated very intensively and get their LDL less than 70 on a statin, having high Lp(a) still carries some independent risks that can't be fully eliminated by our other risk modifying strategies.”</p><p class="pb-2">Black individuals of African descent and South Asian populations frequently have the highest Lp(a) levels, according to the AHA’s 2021 <a rel="nofollow" target="_self" href="https://www.ahajournals.org/doi/full/10.1161/ATV.0000000000000147">scientific statement</a> “Lipoprotein(a): A Genetically Determined, Causal, and Prevalent Risk Factor for Atherosclerotic Cardiovascular Disease.”</p><p class="pb-2">Lp(a) levels of 50 mg/dL (125 nmol/L) or higher contribute to clotting and inflammation, and significantly elevate the the risk of heart attack, stroke, peripheral artery disease; the presence of Lp(a) is especially dangerous for those who have existing CVD or a history of <a rel="nofollow" target="_self" href="https://www.heart.org/en/health-topics/cholesterol/genetic-conditions/familial-hypercholesterolemia-fh">familial hypercholesterolemia</a>.</p><p class="pb-2">Multiple Lp(a) therapies are under development; those in the later stages include:</p><ul class="my-2"><li class="list-disc ml-8">Pelacarsen, an antisense oligonucleotide given once a month. Developed by Ionis/Novartis, its phase 3 HORIZON outcomes trial is expected to be complete in 2025.</li><li class="list-disc ml-8">Olpasiran, an siRNA therapy given every 3 months. Developed by Amgen, its phase 3 OCEAN(a) outcomes trial is scheduled to be complete in 2027.</li></ul><p class="pb-2">Nicholls said the next steps for muvalaplin are phase 3 trials and cardiovascular outcomes trials before the therapy could reach the market. But while studies continue, he said, the first step is knowing who are the patients with high levels of Lp(a). “In most countries around the world, Lp(a) testing is not covered by payers. It's largely an out-of-pocket expense to patients, and that presents an enormous barrier. Many of us in the field are advocating strongly to payers around the world to have Lp(a) testing included in prevention—to be covered—because it is an important tool, as Dr. Michos has already suggested, in terms of the way that we assess risk today, in terms of the way that we try to manage established cardiovascular risk factors.</p><p class="pb-2">“These therapies will come to the clinic, and we need to be able to target the right patient to the right therapy.”</p><p class="pb-2"><strong>Reference</strong></p><p class="pb-2">Nicholls SJ, Wei N, Rhodes GM, et al. Phase 2 trial of an oral small molecule inhibitor of lipoprotein(a) formation. Presented at: American Heart Association Scientific Sessions; November 16-18, 2024; Chicago, IL. 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src="https://cdn.sanity.io/images/0vv8moc6/ajmc/9de113904a026205cbaf84d08420c4065d52fd67-1000x563.jpg?fit=crop&auto=format" alt="Image of Managed Care Cast logo" 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">August 29th 2023</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/the-importance-of-examining-and-preventing-atrial-fibrillation?utm_source=www.ajmc.com&utm_medium=relatedContent">The Importance of Examining and Preventing Atrial Fibrillation</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/the-importance-of-examining-and-preventing-atrial-fibrillation?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">At this year’s American Society for Preventive Cardiology Congress on CVD Prevention, Emelia J. Benjamin, MD, ScM, delivered the Honorary Fellow Award Lecture, “The Imperative to Focus on the Prevention of Atrial Fibrillation,” as the recipient of this year’s Honorary Fellow of the American Society for Preventive Cardiology award.</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/can-a-new-therapeutic-combo-address-a-rare-from-of-rcc-?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4f2785ed36c62151c1a75713a5a03285569a6585-305x305.jpg?fit=crop&auto=format" alt="Wen Kong, MD | Image: Photo provided by ASCO " 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">February 16th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/can-a-new-therapeutic-combo-address-a-rare-from-of-rcc-?utm_source=www.ajmc.com&utm_medium=relatedContent">Can a New Therapeutic Combo Address a Rare Form of RCC?</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/can-a-new-therapeutic-combo-address-a-rare-from-of-rcc-?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Investigators from Shanghai, China, report responses above 90% by using levantinib and tislelizumab to treat patients with a form of renal cell carcinoma (RCC) driven by a mostly inherited mutation.</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/promoting-equity-in-public-health-policy-investment-and-community-engagement-solutions?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">June 28th 2022</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/promoting-equity-in-public-health-policy-investment-and-community-engagement-solutions?utm_source=www.ajmc.com&utm_medium=relatedContent">Promoting Equity in Public Health: Policy, Investment, and Community Engagement Solutions</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/matthew-gavidia">Matthew Gavidia</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/promoting-equity-in-public-health-policy-investment-and-community-engagement-solutions?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">On this episode of Managed Care Cast, we speak with Georges C. Benjamin, MD, executive director of the American Public Health Association, on the core takeaways of his keynote session at AHIP 2022 on public health policy and other solutions to promote equitable health and well-being.</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/powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/3a19b338994d57764d7f408c063ffc36b037edcc-640x410.jpg?fit=crop&auto=format" alt="Powles Highlights “Transformative” Benefit of EV Plus Pembro While Sharing Long-Term Data for EV-302" 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">February 15th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302?utm_source=www.ajmc.com&utm_medium=relatedContent">Powles Highlights “Transformative” Benefit of EV Plus Pembro While Sharing Long-Term Data for EV-302</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/powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The lead investigator for EV-302 said not long ago, survival of 12 to 14 months in this type of bladder cancer was considered an achievement; in this study, median overall survival was 34 months after treatment with enfortumab vedotin (EV) and pembrolizumab (pembro).</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/analysis-looks-at-benefits-toxicity-of-adc-combinations-in-advanced-bladder-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a13ef0cd0e6b56f4e0f3835241425ff4035f5ade-600x450.jpg?fit=crop&auto=format" alt="Analysis Looks at Benefits, Toxicity of ADC Combinations in Advanced Bladder Cancer" 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">February 15th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/analysis-looks-at-benefits-toxicity-of-adc-combinations-in-advanced-bladder-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent">Analysis Looks at Benefits, Toxicity of ADC Combinations in Advanced Bladder Cancer</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/analysis-looks-at-benefits-toxicity-of-adc-combinations-in-advanced-bladder-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">City of Hope's Salvador Jaime-Casas, MD, discusses a systematic review of recent trials examining objective response rate and adverse events of antibody-drug conjugate (ADC) combinations in advanced urothelial cancer. </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/-expanding-access-isn-t-just-about-fairness-it-s-about-building-better-treatments-for-everyone-?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/fb378f5c2512ec02d9e7ea46c60aab1649c99dba-305x305.jpg?fit=crop&auto=format" alt="Regina Barragan-Carrillo, MD | Image: Photo provided by ASCO" 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">February 16th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/-expanding-access-isn-t-just-about-fairness-it-s-about-building-better-treatments-for-everyone-?utm_source=www.ajmc.com&utm_medium=relatedContent">"Expanding Access Isn’t Just About Fairness—It’s About Building Better Treatments for Everyone”</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/regina-barragan-carrillo-md">Regina Barragan-Carrillo, MD</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/interview-by-mary-caffrey">Interview by Mary Caffrey</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/-expanding-access-isn-t-just-about-fairness-it-s-about-building-better-treatments-for-everyone-?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Regina Barragan-Carrillo, MD, a postdoctoral fellow at City of Hope Comprehensive Cancer Center, discussed findings that show 76% of renal cell carcinoma trials take place in wealthy countries, amid news that clinical trial access for the world's poor may become even more challenging.</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/the-importance-of-examining-and-preventing-atrial-fibrillation?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/9de113904a026205cbaf84d08420c4065d52fd67-1000x563.jpg?fit=crop&auto=format" alt="Image of Managed Care Cast logo" 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">August 29th 2023</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/the-importance-of-examining-and-preventing-atrial-fibrillation?utm_source=www.ajmc.com&utm_medium=relatedContent">The Importance of Examining and Preventing Atrial Fibrillation</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/the-importance-of-examining-and-preventing-atrial-fibrillation?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">At this year’s American Society for Preventive Cardiology Congress on CVD Prevention, Emelia J. Benjamin, MD, ScM, delivered the Honorary Fellow Award Lecture, “The Imperative to Focus on the Prevention of Atrial Fibrillation,” as the recipient of this year’s Honorary Fellow of the American Society for Preventive Cardiology award.</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/can-a-new-therapeutic-combo-address-a-rare-from-of-rcc-?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/4f2785ed36c62151c1a75713a5a03285569a6585-305x305.jpg?fit=crop&auto=format" alt="Wen Kong, MD | Image: Photo provided by ASCO " 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">February 16th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/can-a-new-therapeutic-combo-address-a-rare-from-of-rcc-?utm_source=www.ajmc.com&utm_medium=relatedContent">Can a New Therapeutic Combo Address a Rare Form of RCC?</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/can-a-new-therapeutic-combo-address-a-rare-from-of-rcc-?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Investigators from Shanghai, China, report responses above 90% by using levantinib and tislelizumab to treat patients with a form of renal cell carcinoma (RCC) driven by a mostly inherited mutation.</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/promoting-equity-in-public-health-policy-investment-and-community-engagement-solutions?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">June 28th 2022</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/promoting-equity-in-public-health-policy-investment-and-community-engagement-solutions?utm_source=www.ajmc.com&utm_medium=relatedContent">Promoting Equity in Public Health: Policy, Investment, and Community Engagement Solutions</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/matthew-gavidia">Matthew Gavidia</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/promoting-equity-in-public-health-policy-investment-and-community-engagement-solutions?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">On this episode of Managed Care Cast, we speak with Georges C. Benjamin, MD, executive director of the American Public Health Association, on the core takeaways of his keynote session at AHIP 2022 on public health policy and other solutions to promote equitable health and well-being.</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/powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/3a19b338994d57764d7f408c063ffc36b037edcc-640x410.jpg?fit=crop&auto=format" alt="Powles Highlights “Transformative” Benefit of EV Plus Pembro While Sharing Long-Term Data for EV-302" 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">February 15th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302?utm_source=www.ajmc.com&utm_medium=relatedContent">Powles Highlights “Transformative” Benefit of EV Plus Pembro While Sharing Long-Term Data for EV-302</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/powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The lead investigator for EV-302 said not long ago, survival of 12 to 14 months in this type of bladder cancer was considered an achievement; in this study, median overall survival was 34 months after treatment with enfortumab vedotin (EV) and pembrolizumab (pembro).</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/analysis-looks-at-benefits-toxicity-of-adc-combinations-in-advanced-bladder-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a13ef0cd0e6b56f4e0f3835241425ff4035f5ade-600x450.jpg?fit=crop&auto=format" alt="Analysis Looks at Benefits, Toxicity of ADC Combinations in Advanced Bladder Cancer" 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">February 15th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/analysis-looks-at-benefits-toxicity-of-adc-combinations-in-advanced-bladder-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent">Analysis Looks at Benefits, Toxicity of ADC Combinations in Advanced Bladder Cancer</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/analysis-looks-at-benefits-toxicity-of-adc-combinations-in-advanced-bladder-cancer?utm_source=www.ajmc.com&utm_medium=relatedContent"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">City of Hope's Salvador Jaime-Casas, MD, discusses a systematic review of recent trials examining objective response rate and adverse events of antibody-drug conjugate (ADC) combinations in advanced urothelial cancer. </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":"KRAKEN: Oral Muvalaplin Safely Lowers Lp(a) in Early-Stage Trial","datePublished":"2024-11-18T20:52:00.000Z","dateModified":"2024-11-19T13:20:16Z","inLanguage":"en-US","image":"https://cdn.sanity.io/images/0vv8moc6/ajmc/ba7aefa89bdc1169ec3566ccea614e62d7ac7dff-8192x5461.jpg?fit=crop&auto=format","mainEntityOfPage":{"@type":"WebPage","@id":"https://www.ajmc.com/view/kraken-oral-muvalaplin-safely-lowers-lp-a-in-early-stage-trial"},"publisher":{"@type":"Organization","name":"AJMC","logo":{"@type":"ImageObject","url":"https://www.ajmc.com/ajmc_logo_inverted.png"}},"keywords":"Lp(a),lipoprotein(a),KRAKEN,muvalaplin,Eli Lilly,cardiovascular risk","articleBody":"Competition is already heating up in a drug class where therapies are not yet approved, as findings for the first oral drug to lower lipoprotein(a) (Lp[a]) showed promise in a presentation today at the 2024 American Heart Association (AHA) Scientific Sessions, which drew to a close in Chicago, Illinois.\n\n\n\nIn a phase 2 study, muvalaplin was found to significantly reduce Lp(a) using both the traditional test for measuring these particles in the blood, and a new test that more accurately assesses how muvalaplin works to disrupt them, according to lead study author Stephen Nicholls, MBBS, PhD, director of the Victorian Heart Institute at Monash University in Melbourne, Australia.\n\nLp(a) is a genetically driven variant of low-density lipoprotein (LDL) cholesterol, that is known to be an independent risk factor for cardiovascular disease (CVD) and currently has no approved treatments. As commenter Erin D. Michos, MD, MHS, of Johns Hopkins noted at a press briefing, Lp(a) affects about 1 in 5 people worldwide.\n\n\n\nThe 2 major protein components of Lp(a) are apolipoprotein(a), or Apo(a), associated with high-density lipoprotein or “good” cholesterol and apolipoprotein(b), or ApoB, associated with LDL or “bad” cholesterol. Muvalaplin works, Nicholls explained at the press briefing, by disrupting the bonding of apo(a) to apoB, which does not allow Lp(a) to form.\n\nThe study examined 3 different doses, at 10 mg, 60 mg, and 240 mg vs placebo over 12 weeks. To enroll, patients had to have serum level Lp(a) of at least 175 mmol/L.\n\nIn addition, the study team measured how well muvalaplin reduced oxidized phospholipids; Nicholls explained that Lp(a) acts as a “reservoir” for oxidized phospholipids, and “there is a school of thought that this is plays a particular mechanistic role in driving the relationship between Lp(a) and atherosclerotic disease.”\n\nResults showed the study drug significantly reduced oxidized phospholipids as well, he demonstrated. Detailed results showed:\n\nIn the traditional blood test, muvalaplin reduced Lp(a) by 70% compared with placebo, and it reduced Lp(a) by 85.5% in a new test that evaluates “intact” Lp(a) particles, accounting for those particles that might attach to the drug, Nicholls explained.\n\nTreatment with muvalaplin helped 97% of participants to bring Lp(a) levels below 125 nmol/L, as measured by the intact Lp(a) particle test, or about 82% of what they measured with the traditional blood test.\n\nCompared with placebo, muvalaplin lowered ApoB by as much as 16% with no change in high-sensitivity C-reactive protein, which would have indicated heart attack or stroke risk.\n\nThe percentage of serious adverse events was about the same in the placebo arm (6%) as the 10 mg arm (5.9%) , and the percentages were lower in the other arms, with 60 mg at 3.2% and 240 mg at 2.9%.\n\nMuvalaplin, being developed by Eli Lilly, is the latest of the therapies targeting Lp(a) to generate interest at recent cardiology conferences, but the first that would not require injection. Nicholls said these data follow up on previously reported phase 1 results, which showed a reduction of 65% for muvalaplin compared with placebo using the traditional blood test and were reported in JAMA in 2023.\n\nNicholls emphasized that Lp(a) is a distinct, independent risk factor from others that might be treated by primary care physicians and cardiologists; current recommendations call for adults to be tested at least once in their lifetime to learn whether they have elevated levels. But Michos said right now, even when clinicians know a patient has high Lp(a) there is only so much they can do.\n\n“Our current approach is to take an account to both the patient's global cardiovascular risk—so their other risk—as well as their absolute lipoprotein(a) level.”\n\nBy contrast, when treating LDL cholesterol, although there are certain thresholds between intermediate and high risk, she said, “it’s really a continuous threshold,” and “we try to treat all their risk factors the best we can, get their LDL as low as possible. But the reason why this is so important is that even in patients who are treated very intensively and get their LDL less than 70 on a statin, having high Lp(a) still carries some independent risks that can't be fully eliminated by our other risk modifying strategies.”\n\nBlack individuals of African descent and South Asian populations frequently have the highest Lp(a) levels, according to the AHA’s 2021 scientific statement “Lipoprotein(a): A Genetically Determined, Causal, and Prevalent Risk Factor for Atherosclerotic Cardiovascular Disease.”\n\nLp(a) levels of 50 mg/dL (125 nmol/L) or higher contribute to clotting and inflammation, and significantly elevate the the risk of heart attack, stroke, peripheral artery disease; the presence of Lp(a) is especially dangerous for those who have existing CVD or a history of familial hypercholesterolemia.\n\nMultiple Lp(a) therapies are under development; those in the later stages include:\n\nPelacarsen, an antisense oligonucleotide given once a month. Developed by Ionis/Novartis, its phase 3 HORIZON outcomes trial is expected to be complete in 2025.\n\nOlpasiran, an siRNA therapy given every 3 months. Developed by Amgen, its phase 3 OCEAN(a) outcomes trial is scheduled to be complete in 2027.\n\nNicholls said the next steps for muvalaplin are phase 3 trials and cardiovascular outcomes trials before the therapy could reach the market. But while studies continue, he said, the first step is knowing who are the patients with high levels of Lp(a). “In most countries around the world, Lp(a) testing is not covered by payers. It's largely an out-of-pocket expense to patients, and that presents an enormous barrier. Many of us in the field are advocating strongly to payers around the world to have Lp(a) testing included in prevention—to be covered—because it is an important tool, as Dr. Michos has already suggested, in terms of the way that we assess risk today, in terms of the way that we try to manage established cardiovascular risk factors.\n\n“These therapies will come to the clinic, and we need to be able to target the right patient to the right therapy.”\n\nReference\n\nNicholls SJ, Wei N, Rhodes GM, et al. Phase 2 trial of an oral small molecule inhibitor of lipoprotein(a) formation. Presented at: American Heart Association Scientific Sessions; November 16-18, 2024; Chicago, IL. Abstract LBS 08.","description":"Results bring more competition to treat this genetically driven target for cardiovascular risk.","author":[{"@type":"Person","name":"Mary Caffrey"}]}</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 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is already heating up in a drug class where therapies are not yet approved, as findings for the first oral drug to lower lipoprotein(a) (Lp[a]) showed promise in a presentation today at the 2024 ","_key":"def5ddd34f870","_type":"span"},{"_type":"span","marks":["06e81080ffde"],"text":"American Heart Association (AHA) Scientific Sessions","_key":"9adf0f2bddc2"},{"_key":"fda251824ecb","_type":"span","marks":[],"text":", which drew to a close in Chicago, Illinois."}],"_type":"block","style":"normal","_key":"2510a338d28c","upload_doc":null,"uploadAudio":null},{"alt":"Stephen Nicholls, MBBS, PhD | Image credit: Cardiology Society of Australia","alignment":"left","asset":{"_ref":"image-c19314733069c049cbaed91a302836223aa7d1eb-500x500-png","_type":"reference"},"disableLightBox":true,"imgcaption":[{"_type":"block","style":"normal","_key":"329313c9149f","markDefs":[],"children":[{"_key":"a07c49ea58ad","_type":"span","marks":[],"text":"Stephen Nicholls, MBBS, PhD | Image credit: Cardiology 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As commenter Erin D. Michos, MD, MHS, of Johns Hopkins noted at a press briefing, Lp(a) affects about 1 in 5 people worldwide.","_key":"af84dbef009d0"}]},{"upload_doc":null,"medias":null,"disableLightBox":true,"_key":"ec6f5abc2305","_type":"figure","alt":"Erin D. Michos, MD, MHS | Image credit: Johns Hopkins","widthP":25,"uploadAudio":null,"asset":{"_ref":"image-49789b49f6b5f4766e09e6018b26dbed894a5aa5-293x293-webp","_type":"reference"},"alignment":"left","disableTextWrap":false,"imgcaption":[{"_type":"block","style":"normal","_key":"a5df98f9d26a","markDefs":[],"children":[{"_key":"bb70dcc5434c","_type":"span","marks":[],"text":"Erin D. Michos, MD, MHS | Image credit: Johns Hopkins"}]}]},{"_type":"block","style":"normal","_key":"d41bc9424a73","markDefs":[],"children":[{"text":"The 2 major protein components of Lp(a) are apolipoprotein(a), or Apo(a), associated with high-density lipoprotein or “good” cholesterol and apolipoprotein(b), or ApoB, associated with LDL or “bad” cholesterol. Muvalaplin works, Nicholls explained at the press briefing, by disrupting the bonding of apo(a) to apoB, which does not allow Lp(a) to form.","_key":"a9035593d6610","_type":"span","marks":[]}],"upload_doc":null,"uploadAudio":null,"medias":null},{"medias":null,"children":[{"_key":"1dbc88ca4ec70","_type":"span","marks":[],"text":"The study examined 3 different doses, at 10 mg, 60 mg, and 240 mg vs placebo over 12 weeks. To enroll, patients had to have serum level Lp(a) of at least 175 mmol/L."}],"_type":"block","style":"normal","_key":"9b0a95e9f616","markDefs":[],"upload_doc":null,"uploadAudio":null},{"_key":"7698f278b894","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In addition, the study team measured how well muvalaplin reduced oxidized phospholipids; Nicholls explained that Lp(a) acts as a “reservoir” for oxidized phospholipids, and “there is a school of thought that this is plays a particular mechanistic role in driving the relationship between Lp(a) and atherosclerotic disease.”","_key":"343cab19bd160"}],"upload_doc":null,"uploadAudio":null,"medias":null,"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"fb770dd48d6d","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Results showed the study drug significantly reduced oxidized phospholipids as well, he demonstrated. Detailed results showed:","_key":"4298d2c924080"}]},{"_key":"0421f1347029","level":1,"children":[{"_type":"span","marks":[],"text":"In the traditional blood test, muvalaplin reduced Lp(a) by 70% compared with placebo, and it reduced Lp(a) by 85.5% in a new test that evaluates “intact” Lp(a) particles, accounting for those particles that might attach to the drug, Nicholls explained.","_key":"50ae2dc60cb40"}],"_type":"block","style":"normal","listItem":"bullet","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[]},{"style":"normal","_key":"df48811cc380","uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"Treatment with muvalaplin helped 97% of participants to bring Lp(a) levels below 125 nmol/L, as measured by the intact Lp(a) particle test, or about 82% of what they measured with the traditional blood test.","_key":"34603225c0a80"}],"level":1,"_type":"block","listItem":"bullet","markDefs":[],"upload_doc":null},{"listItem":"bullet","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Compared with placebo, muvalaplin lowered ApoB by as much as 16% with no change in high-sensitivity C-reactive protein, which would have indicated heart attack or stroke risk.","_key":"3b1bbf53199b0"}],"level":1,"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"0caafb18f003","_type":"block","style":"normal"},{"children":[{"_type":"span","marks":[],"text":"The percentage of serious adverse events was about the same in the placebo arm (6%) as the 10 mg arm (5.9%) , and the percentages were lower in the other arms, with 60 mg at 3.2% and 240 mg at 2.9%.","_key":"d45f4958a39b0"}],"level":1,"medias":null,"style":"normal","listItem":"bullet","markDefs":[],"uploadAudio":null,"_type":"block","_key":"018a55208c87","upload_doc":null},{"uploadAudio":null,"medias":null,"markDefs":[{"_type":"link","href":"https://jamanetwork.com/journals/jama/fullarticle/2808864","_key":"b75e071adc25"}],"children":[{"_type":"span","marks":[],"text":"Muvalaplin, being developed by Eli Lilly, is the latest of the therapies targeting Lp(a) to generate interest at recent cardiology conferences, but the first that would not require injection. Nicholls said these data follow up on previously reported phase 1 results, which showed a reduction of 65% for muvalaplin compared with placebo using the traditional blood test and ","_key":"9be85e134c930"},{"_type":"span","marks":["b75e071adc25"],"text":"were reported in ","_key":"9be85e134c931"},{"_type":"span","marks":["b75e071adc25","em"],"text":"JAMA","_key":"9be85e134c932"},{"_type":"span","marks":[],"text":" in 2023.","_key":"9be85e134c933"}],"_type":"block","style":"normal","_key":"58784e3a3041","upload_doc":null},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Nicholls emphasized that Lp(a) is a distinct, independent risk factor from others that might be treated by primary care physicians and cardiologists; current recommendations call for adults to be tested at least once in their lifetime to learn whether they have elevated levels. But Michos said right now, even when clinicians know a patient has high Lp(a) there is only so much they can do.","_key":"c95e39f71d1c0"}],"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"ec7a85b03341"},{"upload_doc":null,"uploadAudio":null,"medias":null,"_key":"22859e776cc1","markDefs":[],"children":[{"_key":"11829c68cea30","_type":"span","marks":[],"text":"“Our current approach is to take an account to both the patient's global cardiovascular risk—so their other risk—as well as their absolute lipoprotein(a) level.”"}],"_type":"block","style":"normal"},{"style":"normal","_key":"62e72c6c9b40","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"By contrast, when treating LDL cholesterol, although there are certain thresholds between intermediate and high risk, she said, “it’s really a continuous threshold,” and “we try to treat all their risk factors the best we can, get their LDL as low as possible. But the reason why this is so important is that even in patients who are treated very intensively and get their LDL less than 70 on a statin, having high Lp(a) still carries some independent risks that can't be fully eliminated by our other risk modifying strategies.”","_key":"c392121bd3830"}],"_type":"block"},{"upload_doc":null,"uploadAudio":null,"medias":null,"style":"normal","_key":"f7b68f6dc9be","markDefs":[{"_type":"link","href":"https://www.ahajournals.org/doi/full/10.1161/ATV.0000000000000147","_key":"2f77f604cf46"}],"children":[{"_type":"span","marks":[],"text":"Black individuals of African descent and South Asian populations frequently have the highest Lp(a) levels, according to the AHA’s 2021 ","_key":"2ef9018d9ebf0"},{"_type":"span","marks":["2f77f604cf46"],"text":"scientific statement","_key":"2ef9018d9ebf1"},{"text":" “Lipoprotein(a): A Genetically Determined, Causal, and Prevalent Risk Factor for Atherosclerotic Cardiovascular Disease.”","_key":"2ef9018d9ebf2","_type":"span","marks":[]}],"_type":"block"},{"style":"normal","_key":"1de5a02c7780","markDefs":[{"href":"https://www.heart.org/en/health-topics/cholesterol/genetic-conditions/familial-hypercholesterolemia-fh","_key":"19491898eadb","_type":"link"}],"upload_doc":null,"uploadAudio":null,"medias":null,"children":[{"_type":"span","marks":[],"text":"Lp(a) levels of 50 mg/dL (125 nmol/L) or higher contribute to clotting and inflammation, and significantly elevate the the risk of heart attack, stroke, peripheral artery disease; the presence of Lp(a) is especially dangerous for those who have existing CVD or a history of ","_key":"f753dd6358a40"},{"_key":"f753dd6358a41","_type":"span","marks":["19491898eadb"],"text":"familial hypercholesterolemia"},{"marks":[],"text":".","_key":"f753dd6358a42","_type":"span"}],"_type":"block"},{"medias":null,"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Multiple Lp(a) therapies are under development; those in the later stages include:","_key":"8394187600a20"}],"_type":"block","style":"normal","_key":"ffa9388f794a","upload_doc":null,"uploadAudio":null},{"_key":"9e84f6a13e9e","uploadAudio":null,"level":1,"_type":"block","style":"normal","upload_doc":null,"medias":null,"listItem":"bullet","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Pelacarsen, an antisense oligonucleotide given once a month. Developed by Ionis/Novartis, its phase 3 HORIZON outcomes trial is expected to be complete in 2025.","_key":"82ad68c811fd0"}]},{"style":"normal","markDefs":[],"uploadAudio":null,"medias":null,"_key":"b505f2f7a1c1","listItem":"bullet","children":[{"_type":"span","marks":[],"text":"Olpasiran, an siRNA therapy given every 3 months. Developed by Amgen, its phase 3 OCEAN(a) outcomes trial is scheduled to be complete in 2027.","_key":"9ce2f6b585570"}],"level":1,"_type":"block","upload_doc":null},{"_key":"e37562c10841","upload_doc":null,"uploadAudio":null,"medias":null,"markDefs":[],"children":[{"_key":"2a0390b59e69","_type":"span","marks":[],"text":"Nicholls said the next steps for muvalaplin are phase 3 trials and cardiovascular outcomes trials before the therapy could reach the market. But while studies continue, he said, the first step is knowing who are the patients with high levels of Lp(a). “In most countries around the world, Lp(a) testing is not covered by payers. 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Many of us in the field are advocating strongly to payers around the world to have Lp(a) testing included in prevention—to be covered—because it is an important tool, as Dr. Michos has already suggested, in terms of the way that we assess risk today, in terms of the way that we try to manage established cardiovascular risk factors."}],"_type":"block","style":"normal"},{"uploadAudio":null,"medias":null,"_type":"block","style":"normal","_key":"da8deb342bbe","markDefs":[],"children":[{"_key":"ca4ebd6e1f450","_type":"span","marks":[],"text":"“These therapies will come to the clinic, and we need to be able to target the right patient to the right therapy.”"}],"upload_doc":null},{"_type":"block","style":"normal","upload_doc":null,"uploadAudio":null,"medias":null,"_key":"b29a3a968d57","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Reference","_key":"cbff4a386fcb"}]},{"medias":null,"markDefs":[],"children":[{"marks":[],"text":"Nicholls SJ, Wei N, Rhodes GM, et al. 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Then came the decision by the Trump administration to all but shutter the US Agency for International Development (USAID), which brought at least 30 international "},{"marks":["1566406d8129"],"text":"clinical trials","_key":"d8787b960d7c","_type":"span"},{"marks":[],"text":" to a sudden halt.","_key":"103207f0d079","_type":"span"}],"_type":"block","style":"normal","_key":"7d696f4aa693"},{"children":[{"_type":"span","marks":[],"text":"All this provided an ironic backdrop for Regina Barragan-Carrillo, MD, a postdoctoral fellow at City of Hope Comprehensive Cancer Center, who this week presented results that show clinical trials in renal cell carcinoma (RCC) mostly take place in wealthy countries, even though poverty is ","_key":"e26684e7288a"},{"_key":"259fa7552cea","_type":"span","marks":["d117ed4bf960"],"text":"strongly linked to poor outcomes"},{"_type":"span","marks":[],"text":" in this disease. 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But data show it’s been an uphill battle. The ","_key":"5f77edf8930c"},{"_type":"span","marks":["4960f46ef5a7"],"text":"Lazarex Foundation","_key":"a9b9b13640d2"},{"_type":"span","marks":[],"text":" reported in 2024 that Black patients make up 5% of clinical trial participants, although they are 13% of the US population, and Hispanic patients are only 1% of trial participants even though they are 16% of the population.","_key":"2d258855d265"}],"_type":"block","style":"normal","_key":"58abe502f620"},{"disableTextWrap":false,"alignment":"right","_type":"figure","imgcaption":[{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Regina Barragan-Carrillo, MD | Image credit: ASCO","_key":"ec7da1c61a78"}],"_type":"block","style":"normal","_key":"b0495dd0cbb5"}],"_key":"25c7448ab70d","asset":{"_ref":"image-fb378f5c2512ec02d9e7ea46c60aab1649c99dba-305x305-jpg","_type":"reference"},"widthP":30,"disableLightBox":true,"alt":"Regina Barragan-Carrillo, MD | Image credit: ASCO"},{"children":[{"marks":[],"text":"Barragan-Carrillo’s study focuses on a key problem: too many studies ","_key":"c997868dd4f2","_type":"span"},{"_type":"span","marks":["bd8d730d348a"],"text":"don’t go where the patients are","_key":"46797aebcfbc"},{"_type":"span","marks":[],"text":". ","_key":"3e17faa9a53d"},{"_type":"span","marks":["em"],"text":"The American Journal of Managed Care","_key":"c7e0df6fc349"},{"_type":"span","marks":["sup"],"text":"®","_key":"bc6fe991c306"},{"_type":"span","marks":[],"text":" (","_key":"6f09db41e5d4"},{"marks":["em"],"text":"AJMC","_key":"a2cb77789e25","_type":"span"},{"text":"®","_key":"3eff012875b6","_type":"span","marks":["sup"]},{"_type":"span","marks":[],"text":") spoke with Barragan-Carrillo in San Francisco during ASCO GU about her findings and their importance, given the shifting landscape over support for diversity and equity initiatives in health care.","_key":"ebaa5b85cae2"}],"_type":"block","style":"normal","_key":"5e03a0216bd3","markDefs":[{"href":"https://school.wakehealth.edu/features/research/making-clinical-trials-more-accessible-to-underserved-populations#:~:text=Location%20is%20key,her%20treatment%2C%E2%80%9D%20explained%20Thomas.","_key":"bd8d730d348a","nofollow":true,"blank":true,"_type":"link"}]},{"markDefs":[],"children":[{"text":"This interview has been lightly edited for clarity.","_key":"8e5c3e7e2171","_type":"span","marks":["em"]}],"_type":"block","style":"normal","_key":"dea18df93819"},{"children":[{"_type":"span","marks":[],"text":"","_key":"56a7b736fc05"}],"_type":"block","style":"normal","_key":"56c515e51d26","markDefs":[]},{"children":[{"marks":["strong","em"],"text":"AJMC","_key":"8c193e201565","_type":"span"},{"_type":"span","marks":["strong"],"text":": ","_key":"18a2799e64a7"},{"_type":"span","marks":[],"text":"What do we know about the connections between RCC and poverty?","_key":"1374d76981d3"}],"_type":"block","style":"normal","_key":"cc75fb59a06c","markDefs":[]},{"markDefs":[],"children":[{"_key":"dbe795cd2f0f","_type":"span","marks":["strong"],"text":"Barragan-Carrillo: "},{"_type":"span","marks":[],"text":"We know that lower socioeconomic status is linked to both a higher risk for developing RCC and worse survival outcomes. And these survival outcomes are dependent on later diagnosis and worse access to care, as well as less access to novel systemic therapy.","_key":"7051ddefe1ea"}],"_type":"block","style":"normal","_key":"a992c6ceb3eb"},{"style":"normal","_key":"b8d5d6ad49e7","markDefs":[],"children":[{"_type":"span","marks":[],"text":"For example, here in the US, Black patients [with RCC] have a 16% higher mortality rate compared with their non-Hispanic White counterparts. In Arizona, when we’re talking about patients from Latino origins, it's been documented that these patients are twice as likely to be diagnosed in advanced stages and have nearly double the risk of dying from early-stage disease compared with non-Hispanic White patients.","_key":"82ef87b587dd"}],"_type":"block"},{"_key":"d1444acd5172","markDefs":[],"children":[{"marks":[],"text":"This does not stop at the individual-patient level. On a global scale, people that come from lower-income face even greater barriers to care, with 5-year survival rates up to 50% lower than in wealthier countries. There definitely is an important risk, not only from a biological standpoint, but more from contamination and exposure to environmental factors that could increase the risk for developing the RCC. Access to care also plays a very important role.","_key":"90793999dbd1","_type":"span"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"635238af799c","markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC","_key":"a21fd4bd85b2"},{"_type":"span","marks":["strong"],"text":":","_key":"45a71810a0df"},{"marks":[],"text":" Your findings show that 76% of the trials in RCC were conducted exclusively in high-income countries and that none were available in low-income countries. Beyond the fact that the trials fail to reflect racial and ethnic diversity, what knowledge do we lack about drug delivery in low-income countries when we fail to include them in trials?","_key":"410f86197ad1","_type":"span"}]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Barragan-Carrillo: ","_key":"436cad64c9ad"},{"_type":"span","marks":[],"text":"So, what do we not learn about that process when we don't do the trials in low-income countries? We do not learn a lot, to be quite frank with you, when these trials are not conducted in all sorts of backgrounds. In low-income countries, we are missing critical information about how the treatments work in the real-world setting, but also how drug distribution works.","_key":"4cc25d58c196"}],"_type":"block","style":"normal","_key":"adbc1fa82052"},{"_type":"block","style":"normal","_key":"bf2e25d01598","markDefs":[],"children":[{"_type":"span","marks":[],"text":"For example, how do we ensure that hospitals have the right capability to handle the drug, to have the correct refrigeration system to ensure the quality of the drug is going to be maintained; that it [matches] the quality when they were doing the research in high-income countries. The fact that we're not annotating for that, and we don't have the evidence to support it, also leads to fewer opportunities to improve it.","_key":"cb746b952f42"}]},{"children":[{"text":"It's going to be very hard to have specific steps to improve the quality of care, even for patients who are living in remote areas of the US. We’re missing out on a lot of critical information.","_key":"d66c43111d58","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"0b583d2b7e76","markDefs":[]},{"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC:","_key":"a9fe081c9bb0"},{"_type":"span","marks":[],"text":" What are some other challenges with drug delivery that we could learn about during a clinical trial?","_key":"4d28c160ab25"}],"_type":"block","style":"normal","_key":"cd9a0b84d7bb","markDefs":[]},{"_key":"752ffa51f07a","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Barragan-Carrillo: ","_key":"d576685abcc6"},{"_type":"span","marks":[],"text":"Many patients in [low-to-middle-income countries] have coexisting conditions, such as malnutrition, parasitic infection, or environmental exposures, that do not happen in high-income countries that could alter the drug’s effectiveness. It’s hard to pinpoint a single thing, but the one sure thing is that populations do look very different across the US and across the globe—so all these external factors that are seen more often in other countries are not being shown in the clinical trials. And we're not sure if the interventions that have proven to be effective for patients living in high-income countries are going to be as effective for patients living in other regions of the world.","_key":"0149cbbd64a1"}],"_type":"block","style":"normal"},{"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC:","_key":"f439294a8dea"},{"_type":"span","marks":[],"text":" Your results highlight the disproportionate role that pharma plays in funding trials. Almost all the time, pharma sponsors trials for their own investigational drugs—not for generic drugs that low-income countries would be more likely to afford. Whose job should it be to maintain the infrastructure to pay for those kinds of studies?","_key":"ee5049a95785"}],"_type":"block","style":"normal","_key":"0c3b836d163a","markDefs":[]},{"markDefs":[],"children":[{"_key":"d2ba07c4aa3f","_type":"span","marks":["strong"],"text":"Barragan-Carrillo: "},{"marks":[],"text":"That’s the million-dollar question, to be completely honest. Right now, no one is really taking ownership. If I can be very transparent, pharma companies clearly do focus on the profit and the patent in drug trials, meaning they rarely invest in trials for generics. And even though generics could be game changers for low-income countries, it's something that does not have an economic interest where we ask ourselves, “Who should be the one stepping up?” It has to be a collaborative effort.","_key":"a38cd9ef841d","_type":"span"}],"_type":"block","style":"normal","_key":"9d399fcd14c1"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"First, governments must take a more active role, particularly through public health care agencies and funding bodies and international agencies. For example, the WHO should step up to help coordinate the effort and establish funding mechanisms. [Nongovernmental organizations] have a role to play, especially in implementation; patient advocacy and public and private partnerships can offer a way forward, pairing the infrastructure and expertise from the industry with the public sector funding and global priorities.","_key":"8600bf3972c2"}],"_type":"block","style":"normal","_key":"3f7a8f189114"},{"_type":"block","style":"normal","_key":"a12458b5b191","markDefs":[{"_type":"link","href":"https://dndi.org/","_key":"cc1661a23871","nofollow":true,"blank":true}],"children":[{"_key":"38f1da1e2d8c","_type":"span","marks":[],"text":"An important example that I love to highlight is the "},{"_key":"1bda41775c0b","_type":"span","marks":["cc1661a23871"],"text":"Drugs for Neglected Diseases initiative"},{"_type":"span","marks":[],"text":". It’s a very good model, in the sense that it brings together different stakeholders to fund research on diseases that are disproportionately affecting low-income regions. We need to do something similar in the space of not only RCC, but oncology in general to help patients worldwide.","_key":"9f2af5e5f912"}]},{"style":"normal","_key":"5f236b678968","markDefs":[],"children":[{"_key":"2c5e760781fe","_type":"span","marks":["strong","em"],"text":"AJMC:"},{"_type":"span","marks":[],"text":" Why should it matter to wealthy countries for poor countries to have access to clinical trials? How does everyone benefit when everyone has access?","_key":"293b81b92773"}],"_type":"block"},{"_type":"block","style":"normal","_key":"4188b56cd54f","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Barragan-Carrillo: ","_key":"ba0de3aebef3"},{"_type":"span","marks":[],"text":"First, I think of fairness. Cancer is just not a problem of wealthy countries, so why should clinical research be concentrated there? If we test new therapies only in high-income settings, we end up with treatments that may not be applicable, accessible, or even effective in a large portion of the world's population.","_key":"9f5c45e06bf6"}]},{"children":[{"marks":[],"text":"Right now, we're overwhelmingly concentrated in high-income countries, which is leaving out the majority of the world's patients who have cancer; 70% to 75% of all new cancer cases are happening in lower- and middle-income countries, so we're talking about almost three-quarters of our worldwide patient population. And expanding access isn't just about being fair; it’s also about making treatments better, stronger, and more effective for everyone.","_key":"f0a773a12fe3","_type":"span"}],"_type":"block","style":"normal","_key":"6a97b32b7eee","markDefs":[]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Beyond equity, there are scientific benefits to expanding clinical trials globally. Genetic diversity matters, and it matters a lot in oncology. It matters a lot when you talk about pharmacodynamics and pharmacokinetics; the way patients respond to different cancer treatments can vary a lot on the genetic background, environmental exposures, and underlying health conditions. Including low-income countries in trials gives us more representation on data, and it leads to better and more universally effective treatments.","_key":"e661ad7f500a"}],"_type":"block","style":"normal","_key":"e5c8f37cc26d"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Another thing I’d like to mention is that we learn how to make treatments in health care environments. Not every country is going to have the same access to high-tech imaging, robotic surgery, or expensive immunotherapies. Understanding how to adapt the treatments for different levels of health care infrastructure can help make them more scalable and more accessible worldwide.","_key":"f1e357fffc60"}],"_type":"block","style":"normal","_key":"202c7797ed27"},{"_type":"block","style":"normal","_key":"3341e9fa237e","markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC:","_key":"9f89ce4d1407"},{"text":" So, we might actually learn how to do things in a less expensive way?","_key":"28c67b213c16","_type":"span","marks":[]}]},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Barragan-Carrillo: ","_key":"5614872d703c"},{"text":"Yes, 100%. There’s what we call reverse engineering, where we learn how to adapt certain information in a lower-income setting and then we bring it back to a higher-income setting to be more much more cost-effective. That can allow patients to have access to are without so much financial toxicity.","_key":"6ce152e988e7","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"f5a221f7654d"},{"markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC:","_key":"44d3d6de2b4f"},{"_type":"span","marks":[],"text":" Obviously, you were working on this study for a long time. But you happen to be presenting these results just as the new administration is pulling back on personnel, on funding that supported a lot of this kind of research, and on the infrastructure that supported this work. Many of these decisions, of course, are being contested. What are the implications of presenting your research now, in this changing environment?","_key":"2027dd419be3"}],"_type":"block","style":"normal","_key":"b58c0612b0dd"},{"_key":"732147884602","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Barragan-Carrillo: ","_key":"5c13537c901e"},{"_type":"span","marks":[],"text":"I think scaling back this type of funding, it's a major step in the wrong direction. From a scientific point of view, cutting funding from whole global health research doesn't just slow down the progress, it actively worsens these priorities. The broader implications are quite concerning. It could mean less innovation….","_key":"8fb9d0c9c9ee"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"4bbc4f9ccb65","markDefs":[],"children":[{"_type":"span","marks":[],"text":"This could lead to worse patient outcomes. If trials only happen in wealthy regions, we'll continue to see major inequities in who benefits from scientific answers. It leads to a weaker international collaboration, which not only has an impact on health care, but also an economic and social impact.","_key":"b9bcaab9301b"}]},{"style":"normal","_key":"646177e6c710","markDefs":[],"children":[{"_key":"d0c3e71e6bc2","_type":"span","marks":[],"text":"Global health efforts rely not only on partnerships, they also rely on collaboration between groups and between countries. So, when the funding disappears, these partnerships end up breaking down. Rebuilding them is going to take years. At a time when we should be looking at expanding clinical trial access, these cuts do the exact opposite—by shrinking opportunities, limiting research, and ultimately costing 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The combination of lenvatinib and tislelizumab was tested on 17 patients, with 15 assessable at data cutoff. The study reported a complete response in 20% of patients, though adverse events were common. FH-RCC, driven by FH gene mutations, is aggressive and hard to diagnose. The study suggests this combination could be a promising alternative for FH-RCC treatment, though further research is needed.","authorMapping":[{"_id":"author_6732921f288a3775abb89da57903428b","biography":[{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Mary Caffrey is the Executive Editor for The American Journal of Managed Care® (","_key":"9737335da1ed0"},{"_type":"span","marks":["em"],"text":"AJMC","_key":"b8dda18bb0dc"},{"_type":"span","marks":[],"text":"®). 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All grade adverse events (AEs) were seen in 16 patients (94.1%), and grade 3 or higher events were seen in 4 patients (23.5%). Eight patients had to have dose reductions or stop treatment (47.1%). One patient died due to unrelated lung metastases.","_key":"6ea3d231f86f"}],"_type":"block","style":"normal","_key":"e697ac41b7f3"},{"_type":"block","style":"normal","_key":"30693cd45bf1","markDefs":[],"children":[{"_key":"bc021a5e60c9","_type":"span","marks":["strong"],"text":"What is FH-RCC?"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Driven mostly by germline mutations, FH-RCC tends to affect adults in their mid-30s or early 40s. It is hard to diagnose, as its symptoms may be mistaken for normal abdominal pain. It metastasizes early, even when tumors are small. Genetic testing is encouraged when families are known to carry the FH mutation, which brings an estimated 15% lifetime risk of developing RCC.","_key":"a8a7ebc2aea6"}],"_type":"block","style":"normal","_key":"79c8b7113a4f"},{"_key":"55f2209188b7","markDefs":[{"_type":"link","href":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9337267/#:~:text=Fumarate%20hydratase%20(FH)%20%2D%20deficient%20renal%20cell,sporadic%20loss%2Dof%2Dfunction%20mutation%20in%20the%20FH%20gene.\u0026text=Although%20RCC%20occurs%20only%20in%20a%20minority,patients%20with%20stage%203%20to%204%20disease","_key":"d50a9a6596d8"}],"children":[{"marks":[],"text":"According to ","_key":"8b5a0a45c4cd","_type":"span"},{"_type":"span","marks":["d50a9a6596d8"],"text":"Linder et al,","_key":"b97e63a1bb4c"},{"_key":"8516495a7b63","_type":"span","marks":[],"text":" FH-RCC occurs when the loss-of-function mutation in the FH gene leads to the accumulation of fumarate, in turn activating hypoxia-inducible factor (HIF). Then, HIF triggers tumor growth through several mechanisms, involving both vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR); thus, therapeutic targets can include an anti-EGFR blockade."}],"_type":"block","style":"normal"},{"_key":"5a35e8e25f81","markDefs":[],"children":[{"_key":"199d0828a3c3","_type":"span","marks":["strong"],"text":"Why Look for Something New?"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"e90b7ceff5da","markDefs":[],"children":[{"_type":"span","marks":[],"text":"As Kong explained, a combination appearing on the National Comprehensive Cancer Network guidelines featured bevacizumab (Avastin; Genentech), an anti-VEGF monoclonal antibody, and erlotinib (Tarceva; Genentech), an anti-EGFR tyrosine kinase inhibitor (TKI).","_key":"c185498d3e67"}]},{"_key":"c49c563621cd","markDefs":[],"children":[{"_key":"0931031453d4","_type":"span","marks":[],"text":"But the study that led to that recommendation is more than 10 years old, Kong said, “and the landscape for RCC treatment has dramatically changed.” "}],"_type":"block","style":"normal"},{"_key":"79c4a6b36ef4","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The addition of checkpoint inhibitors and newer generation of TKIs warranted a second look, and Kong’s center did just that in a 2023 retrospective study of how patients with FH-RCC fared when treated with different combinations in centers across China.","_key":"395b81645f6d"}],"_type":"block","style":"normal"},{"_key":"33ed2e182cc1","markDefs":[],"children":[{"_type":"span","marks":[],"text":"That paper, for which Kong was second coauthor, found better survival rates when combining a TKI with an immune checkpoint inhibitor.","_key":"c9fe2a18792b"},{"_type":"span","marks":["sup"],"text":"2","_key":"640f02e63a15"}],"_type":"block","style":"normal"},{"markDefs":[{"_type":"link","href":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10441075/#:~:text=Tislelizumab%20plus%20chemotherapy%20is%20effective,NSCLC%20after%20EGFR%20TKI%20failure","_key":"8a2e2dd1497e"}],"children":[{"text":"The PD-1 inhibitor tislelizumab is known to be effective with chemotherapy for patients with ","_key":"6f676367ed2e","_type":"span","marks":[]},{"marks":["em","8a2e2dd1497e"],"text":"EGFR-","_key":"be231dc87434","_type":"span"},{"marks":["8a2e2dd1497e"],"text":"mutated","_key":"83deee94eacc","_type":"span"},{"_type":"span","marks":[],"text":" nonsquamous non–small cell lung cancer who progressed on EGFR TKI therapy.","_key":"04dc6fec4135"}],"_type":"block","style":"normal","_key":"bff0950f49f0"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Lenvatinib, meanwhile, is a TKI that works on multiple targets to block new blood vessel formation, thereby limiting blood supply to the tumor; among its targets are VEGF receptors (VEGFR1-3).","_key":"c2494da78210"}],"_type":"block","style":"normal","_key":"73d460348d8b"},{"markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Background and Methods","_key":"6176e729746b"}],"_type":"block","style":"normal","_key":"02282c5b7e14"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Eligible patients were 18 to 80 years of age and diagnosed with pathologically confirmed, unresectable advanced or metastatic FH-RCC and had not received systemic therapy. Diagnosis was confirmed with DNA sequencing. Patients received concurrent therapy, with lenvatinib administered 20 mg by mouth daily and tislelizumab 200 mg intravenously every 3 weeks until disease progression, intolerable toxicity, or withdrawn consent.","_key":"ac5ba4896464"}],"_type":"block","style":"normal","_key":"2966f0aef5f2"},{"children":[{"_type":"span","marks":[],"text":"The primary end point is ORR; secondary end points are disease control rate, PFS, duration of response, 1-year and 2-year OS rate, and safety.","_key":"b973d5eb5e87"}],"_type":"block","style":"normal","_key":"8a99f0a62d21","markDefs":[]},{"markDefs":[],"children":[{"marks":[],"text":"Patients enrolled from September 2023 to October 2024; 14 were male and 3 female. Median age was 37 (24-61) years. FH germline alterations were found in 12 patients, with 5 carrying somatic mutations. Median follow-up was 7.0 months (1.0-12.0 months).","_key":"56cced9e0edb","_type":"span"}],"_type":"block","style":"normal","_key":"72761013a41d"},{"children":[{"_type":"span","marks":[],"text":"Kong shared before-and-after photos showing tumor shrinkage. He acknowledged that the data are immature and many questions remain, but concluded, “This combination might become a promising alternative option,” for patients with FH-RCC.","_key":"d6d4d11a9199"}],"_type":"block","style":"normal","_key":"5c38eeb7d00c","markDefs":[]},{"style":"normal","_key":"ee83a539ada9","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"References","_key":"e72323425164"}],"_type":"block"},{"markDefs":[],"children":[{"marks":[],"text":"1. Kong W, Xu Y, Wang Z, Zhang J. Lenvatinib plus tislelizumab as first-line therapy for advanced fumarate hydratase-deficient renal cell carcinoma. A single-center, single-arm phase 2 study. ","_key":"5ddd28b0f6fc","_type":"span"},{"_type":"span","marks":["em"],"text":"J Clin Oncol","_key":"2cc0e028f089"},{"_type":"span","marks":[],"text":". 2025;43(suppl 5):Abstract 443. doi:10.1200/JCO.2025.43.5_suppl.443","_key":"fb83441b5295"}],"_type":"block","style":"normal","_key":"e648c61d2819"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"2. Xu Y, Kong W, Cao M, et al. Genomic profiling and response to immune checkpoint inhibition plus tyrosine kinase inhibition in FH-deficient renal cell carcinoma. ","_key":"0dd49b6d625a"},{"marks":["em"],"text":"Eur Urol","_key":"22d373c2fe2c","_type":"span"},{"marks":[],"text":". 2023;83(2):163-172. doi:10.1016/j.eururo.2022.05.029","_key":"236f2bb6f7ba","_type":"span"}],"_type":"block","style":"normal","_key":"a25d45af67b6"}],"summary":"Investigators from Shanghai, China, report responses above 90% by using levantinib and tislelizumab to treat patients with a form of renal cell carcinoma (RCC) driven by a mostly inherited mutation.","is_visible":true,"seoTag":["renal cell carcinoma","FH-RCC","rare disease","BeiGene","tislelizumab","levantinib","TKI inhibitor","PD-1 inhibitor"],"gptTakeaways":"• A phase 2 study showed a 93.3% objective response rate for lenvatinib and tislelizumab in FH-RCC patients, with a 20% complete response rate.\n\n• FH-RCC is driven by FH gene mutations, leading to early metastasis and challenging diagnosis, often affecting young adults.\n\n• The study reported adverse events in 94.1% of patients, with 23.5% experiencing 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You can connect with Mary on ","_key":"c2027cf5a357"},{"_type":"span","marks":["4f88673cb2c4"],"text":"LinkedIn","_key":"9737335da1ed1"},{"_type":"span","marks":[],"text":".","_key":"9737335da1ed2"}],"_type":"block","style":"normal","_key":"a03d32973d6e"}],"_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"}],"seoTag":["pembrolizumab","EV-302","enfortumab vedotin","Padcev","Keytruda","bladder cancer","advanced urothelial sarcoma","adverse events"],"gptTakeaways":"• Enfortumab vedotin and pembrolizumab combination offers transformative benefits, doubling median progression-free and overall survival in advanced urothelial carcinoma.\n\n• The EV-302 trial showed a 74% likelihood of maintaining a complete response at two years and a 49% reduction in the risk of death.\n\n• Updated data revealed a median overall survival of 33.8 months, with significant improvements across various subgroups, including non-White patients.\n\n• Adverse events were manageable, with no new safety signals; diarrhea and rash were the most common grade 3 or higher events.\n\n• The optimal duration of therapy remains under discussion, with experts considering the balance between treatment benefits and patient quality of life.","ExcludeFromPubMedXML":false,"summary":"The lead investigator for EV-302 said not long ago, survival of 12 to 14 months in this type of bladder cancer was considered an achievement; in this study, median overall survival was 34 months after treatment with enfortumab vedotin (EV) and pembrolizumab (pembro).","url":"powles-highlights-transformative-benefit-of-ev-plus-pembro-while-sharing-long-term-data-for-ev-302","title":"Powles Highlights “Transformative” Benefit of EV Plus Pembro While Sharing Long-Term Data for EV-302","audioUrl":"https://s3.us-east-1.amazonaws.com/ai-generated-audios/www.ajmc.com/4558ddec-cea0-44fa-8b00-9bc10ca97dbc_1739627626518.154c20c8-6ac1-48ca-bcd9-f91bba14ea38.mp3","_type":"article","_rev":"SFmeZvllcTepotsRP0fWyP","factCheckAuthors":null,"articleType":"News","is_visible":true,"contentCategory":{"_id":"3f4b3ced-7c9d-4fc4-967f-fe993087cce2","_updatedAt":"2023-09-29T14:32:27Z","_createdAt":"2020-04-03T20:03:53Z","_rev":"Q2ZL7ihdIB33NiMMcGccmh","_type":"contentCategory","name":"Articles"},"_createdAt":"2025-02-15T13:44:47Z","drugMentions":"{\n \"drug_mentions\": [\"enfortumab vedotin\", \"pembrolizumab\", \"cisplatin\", \"PADCEV®\", \"KEYTRUDA®\"]\n}","factCheckAuthorMapping":null,"gptSummary":"Combining enfortumab vedotin with pembrolizumab significantly improves outcomes for patients with advanced urothelial carcinoma, offering transformative benefits over traditional chemotherapy. The EV-302 trial demonstrated a 74% likelihood of maintaining a complete response at two years and a 49% reduction in the risk of death. The combination doubled median progression-free and overall survival, with updated data showing a median overall survival of 33.8 months. Adverse events were manageable, with no new safety signals. The optimal duration of therapy remains a topic of discussion among experts.","_updatedAt":"2025-02-16T04:20:35Z","thumbnail":{"_type":"mainImage","asset":{"_ref":"image-3a19b338994d57764d7f408c063ffc36b037edcc-640x410-jpg","_type":"reference"}},"documentGroup":{"name":"ASCO GU: ASCO Genitourinary Cancers 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Symposium"}],"_createdAt":"2025-02-15T04:07:37Z","body":[{"markDefs":[],"children":[{"text":"Antibody-drug conjugates (ADCs), used with and without immunotherapy, have been game-changers in treating advanced urothelial carcinoma (aUC), a bladder cancer that spreads to other parts of the body. Yet, there have been tradeoffs: in some cases, patients see results but experience adverse events (AEs), including skin rashes.","_key":"f421cc4031eb","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"b25e0004b962"},{"alignment":"left","widthP":25,"disableTextWrap":false,"disableLightBox":true,"imgcaption":[{"children":[{"_type":"span","marks":[],"text":"Salvador Jaime-Casas, MD | Image credit: X","_key":"3ad7b780bea4"}],"_type":"block","style":"normal","_key":"a29c698ec042","markDefs":[]}],"_key":"96b90b6eb43d","_type":"figure","asset":{"_ref":"image-e53c36fe3de257cfba46535f2909dfe433a299c3-400x400-jpg","_type":"reference"},"alt":"Salvador Jaime-Casas, MD | Image credit: X"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"To gain a better understanding of the data on ADC combinations in aUC, investigators led by Salvador Jaime-Casas, MD, a post-doctoral research fellow in the Department of Genitourinary Oncology at City of Hope, in Los Angeles, California, led a systematic review of 5 recent trials involving the use of sacituzumab govitecan (Trodelvy; Gilead) and enfortumab vedotin (Padcev; Astellas/Seagen) in combination regimens. Jaime-Casas presented in a poster","_key":"5e48b7e02ee5"},{"_type":"span","marks":["sup"],"text":"1","_key":"71ff41aa1915"},{"_type":"span","marks":[],"text":" at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which met February 13-15, 2025, in San Francisco, California.","_key":"fd44e4c4aece"}],"_type":"block","style":"normal","_key":"ba12690dcf8c"},{"children":[{"_type":"span","marks":[],"text":"The 2 ADC therapies have had different paths in bladder cancer. Sacituzumab govitecan (SG) was granted ","_key":"b0494d00b130"},{"text":"accelerated approval","_key":"a23cf4bfd1aa","_type":"span","marks":["ae354bb7ead3"]},{"_type":"span","marks":[],"text":" as a monotherapy in April 2021 to for patients with previously treated aUC. However, last fall Gilead voluntary withdrew it from the market after follow-up data failed to meet end points for overall survival (OS).","_key":"beb410689319"},{"text":"2","_key":"0dd0ab237368","_type":"span","marks":["sup"]},{"_type":"span","marks":[],"text":" A recent report from the HHS ","_key":"0cfc21927151"},{"_key":"5ed236923095","_type":"span","marks":["3cf4d935dec4"],"text":"Office of the Inspector General"},{"_type":"span","marks":[],"text":" highlighted the frequency of cancer therapies being pulled from the market, sometimes years after receiving an accelerated approval, when long-term data fail to meet end OS targets.","_key":"07bda595d094"}],"_type":"block","style":"normal","_key":"592e20449d79","markDefs":[{"_type":"link","href":"https://www.onclive.com/view/fda-approves-sacituzumab-govitecan-for-advanced-urothelial-cancer","_key":"ae354bb7ead3"},{"href":"https://www.ajmc.com/view/oig-report-seeks-better-oversight-records-for-fda-s-accelerated-approvals","_key":"3cf4d935dec4","nofollow":true,"blank":true,"_type":"link"}]},{"markDefs":[{"_type":"link","href":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-enfortumab-vedotin-ejfv-locally-advanced-or-metastatic-urothelial-cancer","_key":"12172197ff07"}],"children":[{"_type":"span","marks":[],"text":"Enfortumab vedotin (EV), meanwhile, received a ","_key":"47aa2a0c6607"},{"_key":"55b0cc94ae18","_type":"span","marks":["12172197ff07"],"text":"regular approval"},{"_key":"51bd2f3c1a74","_type":"span","marks":[],"text":" for previously treated patients with locally advanced or metastatic urothelial cancer in July 2021. Then, in December 2023, a combination with pembrolizumab (Keytruda; Merck) received accelerated approval to treat all newly diagnosed patients with aUC, based on the phase 3 EV-302 trial."}],"_type":"block","style":"normal","_key":"db59ddc81efd"},{"markDefs":[{"_type":"link","href":"https://www.ajmc.com/view/positive-os-for-bladder-cancer-combo-biomarkers-on-tap-at-asco-gu-2025","_key":"c958d886fb62"}],"children":[{"_type":"span","marks":[],"text":"Final OS data from the EV-302 trial, ","_key":"c0c45ff610e3"},{"_key":"c06e681e930f","_type":"span","marks":["c958d886fb62"],"text":"announced ahead"},{"_type":"span","marks":[],"text":" of ASCO GU and presented Friday showed that the combination of EV and pembrolizumab cut the risk of death 49% compared with chemotherapy.","_key":"c9bb5b7b9ee8"},{"_type":"span","marks":["sup"],"text":"3","_key":"60ff8dfd4d67"}],"_type":"block","style":"normal","_key":"bac68de3ef33"},{"_key":"b1b47594cc1c","markDefs":[],"children":[{"_type":"span","marks":[],"text":"The trials in the review presented at ASCO GU were: the phase 1 DAD trial (NCT04724018) that studied the dual ADC combination of sacituzumab govitecan (SG) and EV; the EV-302 trial (NCT04223856) combining EV and pembrolizumab; EV-301 (NCT03474107), cohort K, a phase 1b/2 study that also evaluated EV plus pembrolizumab; EV-103 (NCT03288545), cohort A, also phase 1b/2; and TROPHY-U-01 (NCT03547973), the phase 3 study evaluating SG plus pembrolizumab.","_key":"b8ef95a06d35"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"Investigators identified 627 evaluable patients from these 5 trials; they recorded an objective response rate (ORR) of 66.2%, and 366 patients across all studies had AEs of grade 3 or higher, for a risk rate (RR) of 58.4%. The most common AE of at least grade 3 was neutropenia (RR 0.14), followed by anemia (RR 0.10), and maculopapular rash (RR 0.10). Data presented on the poster showed that there was a higher incidence of AEs of at least grade 3 in the SG-based regimens compared with the EV-based regimens.","_key":"c07142774811"}],"_type":"block","style":"normal","_key":"9ef2d867f053"},{"_type":"block","style":"normal","_key":"f3a57661530e","markDefs":[],"children":[{"text":"This week, Jaime-Casas joined ","_key":"ec6e5027b466","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"The American Journal of Managed Care","_key":"fe1145ba5391"},{"text":"®","_key":"a8fb3552a69e","_type":"span","marks":["sup"]},{"_type":"span","marks":[],"text":" (","_key":"5f292ad88cb7"},{"marks":["em"],"text":"AJMC","_key":"cab9bdd287c1","_type":"span"},{"marks":["sup"],"text":"®","_key":"09eb8ae6d927","_type":"span"},{"_type":"span","marks":[],"text":") for an interview about the findings and what they mean within the context of recent news surrounding ADCs.","_key":"45527d8827c6"}]},{"_type":"block","style":"normal","_key":"ea839dbed8bb","markDefs":[],"children":[{"_key":"af4deeb8389c","_type":"span","marks":[],"text":"This interview has been lightly edited for length and clarity."}]},{"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC","_key":"86898dfd9d08"},{"_type":"span","marks":["strong"],"text":":","_key":"2c26432d19d8"},{"text":" Your findings note that the AE incidence varied by regimen, with events being more common in SG-based regimens. Last fall, Gilead announced it was withdrawing an indication for SG in aUC based on overall survival data. Do the data in your study offer support for that decision?","_key":"dcc5f27169b5","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"aadf05d98225","markDefs":[]},{"_key":"a148c68eaa51","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Jaime-Casas:","_key":"6253f5d13ff3"},{"_type":"span","marks":[],"text":" The systematic reiew evaluated 5 prospective clinical trials using either in EV or SG as combination-based regimens. So, for most of these trials, it was SG or EV in combination with immunotherapy. And although we did not analyze overall survival, recurrence-free survival, which was part of the reason why SG was pulled off the market, because the TROPiCS-04 trial (NCT0457991) failed to show this improved survival compared to chemotherapy, we also mirror these results by showing that there is a modest improvement in the objective response rate, that comes at the cost of a high rate of adverse events, particularly grade 3 or above adverse events. And these were actually very similar if you look at the TROPiCS-04 publication","_key":"2005ca277a25"},{"_type":"span","marks":["sup"],"text":"4","_key":"2216d831341d"},{"marks":[],"text":" and our results, we also recorded that one of the highest adverse events for patients receiving sacituzumab govitecan was neutropenia. We record hematological adverse events such as neutropenia, anemia and diarrhea.","_key":"15c0d33fca97","_type":"span"}],"_type":"block","style":"normal"},{"markDefs":[],"children":[{"_key":"a7f62b37f5f1","_type":"span","marks":[],"text":"So, I would say, although our analyses are not the same, because we do not assess in our paper the recurrence-free survival and recurrence-free survival, they do reflect the same trend, and that is even if there is some benefit to receiving this therapy, it is modest at best, and it comes at the cost of a high rate of adverse events."}],"_type":"block","style":"normal","_key":"98c214fd4e99"},{"markDefs":[],"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC","_key":"590721ce0047"},{"text":": ","_key":"6f296692a946","_type":"span","marks":["strong"]},{"text":"How should payers view these results? Are there steps that can be taken to mitigate AEs that payers should support/encourage?","_key":"ed177c500ee0","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"9674c9c8c387"},{"_type":"block","style":"normal","_key":"41350bac5e7a","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Jaime-Casas:","_key":"41ef8333b0f3"},{"_type":"span","marks":[],"text":" Definitely, in the context of EV, it's a little bit more safe to say that payers should invest more money, as we know that EV-[pembrolizumab] has been recently approved in the metastatic setting in patients who have previously been untreated. But I think in particular for sacituzumab govitecan-based regimens and combination regimens, payers should be a little bit more cautious, not only because of the cost of medication, but also because of the cost associated with care for these adverse events.","_key":"c8d662466c41"}]},{"_key":"ef1b74f4f722","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Essentially, we know that patients who have a high chance of encountering things like hematological toxicity, neutropenia or anemia may require more frequent blood evaluation. Some patients may even require transfusions of blood units or even like colony stimulating factors. At least from the perspective of a [genitourinary] clinic, this is very multidisciplinary in nature. I think one of the associated costs that payers should focus on would be multi-disciplinary teams that include medical oncologists, but [they should] also considered dermatologists and even pharmacists who are able to make modifications to the dosages if we encounter these toxicities.","_key":"1ed6beb46229"}],"_type":"block","style":"normal"},{"style":"normal","_key":"63a3aa2ee9d7","markDefs":[],"children":[{"marks":["strong","em"],"text":"AJMC:","_key":"13ba2a7ef1b7","_type":"span"},{"_type":"span","marks":[],"text":" Is it known how AE differences compare when ADCs were used in second-line treatment vs first-line?","_key":"4834c2a4c072"}],"_type":"block"},{"_key":"17ed0020d65f","markDefs":[],"children":[{"text":"Jaime-Casas:","_key":"90ecc99005d0","_type":"span","marks":["strong"]},{"_type":"span","marks":[],"text":", I would say right now, we do not have very mature data to strictly say, what are the things we could expect for patients who receive an ADC firstline. We can definitely expect a much better functional baseline status, and patients may be able to tolerate a little bit more toxicity before withholding or discontinuing completely the drug, in contrast with patients who may be receiving it as their second- or third-line treatment. So, for instance, if we talk about EV-302 we know that in this case, EV and [pembrolizumab], which is part of our poster in our systematic review, this was given in patients who were treatment naïve. So, it was given firstline, and patients were able to tolerate it more. But when we talk about, for instance, the TROPICS-04 patients, this was a heavily pretreated patient population. This frailty may also impact the results, as these patients already have some hematological malignancies, myelosuppression, or even peripheral neuropathy from previous platinum-based chemotherapy.","_key":"b541f2a4ec26"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"4af208c978ca","markDefs":[{"_key":"53a255053cce","nofollow":true,"blank":true,"_type":"link","href":"https://www.ajmc.com/view/how-antibody-drug-conjugates-and-chemotherapy-shortages-are-affecting-patients-with-bladder-cancer"}],"children":[{"_type":"span","marks":["strong","em"],"text":"AJMC:","_key":"f560f8476e43"},{"text":" During part of the period that your data covers, we were experiencing a severe cisplatin shortage. ","_key":"da99b2427939","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"AJMC","_key":"76d29ae7d941"},{"marks":[],"text":" was ","_key":"59ad27b65d1d","_type":"span"},{"_type":"span","marks":["53a255053cce"],"text":"talking in real time","_key":"f38b88d66442"},{"text":" with doctors who used ADCs instead of cisplatin to treat patients, because sometimes nothing else was available—although cisplatin was indicated in the National Comprehensive Cancer Network (NCCN) guidelines for firstline treatment. Can physicians look at the data you are presenting and gain comfort about those decisions, especially if they may someday be confronted with not having cisplatin available?","_key":"5130d07ac0b9","_type":"span","marks":[]}]},{"style":"normal","_key":"3a653244d8cd","markDefs":[],"children":[{"_type":"span","marks":["strong"],"text":"Jaime-Casas:","_key":"6646fe7988eb"},{"_type":"span","marks":[],"text":", in our data, what we did find is there is a promising objective response rate seen overall for these 5 included studies. Three of the studies that we included, EV-302 and EV-103 cohort A and cohort K were given in the context of EV plus immunotherapy. And you know, for EV-103, for that study, this one of the inclusion criteria was patients who were cisplatin ineligible already. So, I think the comfort here is that at least in the context of EV therapy, we could say that it was good at that moment before it was approved; it was a good alternative when you were encountering a patient with advanced urothelial carcinoma, and you had this context of a cisplatin shortage. Giving EV in this disease setting was not a bad option, because we do see that there is a tolerable adverse event profile and optimal response. 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