Immunotherapy Combination Approved for Colorectal Cancer

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CC BY 4.0.</div> </div> </figcaption> </figure> </div> <p>On July 10, the Food and Drug Administration (FDA) approved the combination of two <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000045729&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045729&version=Patient&language=English">immunotherapy</a> drugs—<a data-entity-substitution="canonical" data-entity-type="node" href="/about-cancer/treatment/drugs/ipilimumab" data-entity-uuid="24a0379c-992b-44de-8414-626a682b015b">ipilimumab (Yervoy)</a> and <a data-entity-substitution="canonical" data-entity-type="node" href="/about-cancer/treatment/drugs/nivolumab" data-entity-uuid="0ebd801b-ec5f-45e3-97c4-f40a5b0cf2ca">nivolumab (Opdivo)</a>—for the treatment of some patients with metastatic colorectal cancer who have been treated previously with standard chemotherapy drugs. </p> <p>The accelerated approval covers patients 12 years of age and older whose tumors have one of two genetic features that prevent cells from repairing damaged DNA: <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000789741&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000789741&version=Patient&language=English">mismatch repair deficiency</a> (dMMR) or high <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000285933&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000285933&version=Patient&language=English">microsatellite instability</a> (MSI-H).</p> <p>Tumors that have either of these genetic features tend to have high rates of DNA mutations. Some of these mutations may lead to the production of many abnormal <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000046086&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000046086&version=Patient&language=English">antigens</a> that can be targeted by <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000046356&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000046356&version=Patient&language=English">immune cells</a>.</p> <p>Researchers have found that several immune checkpoint inhibitors are effective in patients with MSI-H or dMMR tumors, and this work has led to FDA approvals.</p> <p>In 2017, <a data-entity-substitution="canonical" data-entity-type="node" href="/news-events/cancer-currents-blog/2017/fda-pembrolizumab-genetic-features" data-entity-uuid="8bd093dc-45f2-4f05-a2b8-b12504f604bf">FDA approved the checkpoint inhibitor pembrolizumab (Keytruda)</a> for the treatment of MSI-H or dMMR tumors, regardless of where in the body the cancer started. This was the first FDA approval based solely on the presence of a genetic feature in a tumor.</p> <p>The approval was a step forward for <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000741769&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000741769&version=Patient&language=English">precision medicine</a>, noted James Gulley, M.D., Ph.D., head of the immunotherapy section of NCI’s <a href="https://ccr.cancer.gov/">Center for Cancer Research</a>.</p> <p>A few months later, FDA approved <a data-entity-substitution="canonical" data-entity-type="node" href="/news-events/cancer-currents-blog/2017/nivolumab-fda-colorectal" data-entity-uuid="9c3cf45e-ea77-4efd-b968-2523ac61b050">nivolumab for patients with MSI-H or dMMR metastatic colorectal cancer</a> that has progressed after chemotherapy.</p> <h2>The CheckMate-142 Study</h2> <p>The new FDA approval was based on results from the CheckMate-142 study, which was funded by Bristol-Myers Squibb, the manufacturer of ipilimumab and nivolumab.</p> <p>The clinical trial is testing nivolumab alone and in combination with other anticancer drugs, including ipilimumab, in patients with dMMR or MSI-H metastatic colorectal cancer that had progressed after treatment with <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000386207&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000386207&version=Patient&language=English">fluoropyrimidine</a>- and <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000045465&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045465&version=Patient&language=English">oxaliplatin</a>-containing chemotherapy or fluoropyrimidine- and <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000045391&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045391&version=Patient&language=English">irinotecan</a>-containing chemotherapy. </p> <p>Among 82 patients in the trial who received the combination immunotherapy, 3 had <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000045652&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045652&version=Patient&language=English">complete responses</a> and 35 had <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000045819&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045819&version=Patient&language=English">partial responses</a>, for an overall response rate of 46%. In addition, 89% of the responses lasted 6 months or longer, according to FDA.</p> <p>The FDA statement noted that the overall response rate among a similar group of 58 patients who received nivolumab alone was 28%, with 67% of the responders having responses that lasted 6 months or more.</p> <p>The most common side effects among the patients receiving ipilimumab and nivolumab included fatigue, diarrhea, fever, musculoskeletal pain, and abdominal pain. The combination immunotherapy had a “manageable safety profile,” the researchers wrote in <a href="https://www.ncbi.nlm.nih.gov/pubmed/29355075">a report on the CheckMate-142 study</a> earlier this year.</p> <h2>Assessing the Various Treatment Options for Patients</h2> <p>Although CheckMate-142 did not include an arm testing pembrolizumab in the same patient population, Dr. Gulley noted that the response rates for both are similar (46% for the combination and 40% for pembrolizumab alone)—and higher than that for nivolumab alone (28%).</p> <p>“This combination immunotherapy is an important additional option for patients,” he said, noting that pembrolizumab, as a single agent, may have fewer side effects than the two-drug combination.</p> <p>“We don’t know if there are patients who would respond to nivolumab and ipilimumab who wouldn’t respond to pembrolizumab or vice versa,” Dr. Gulley continued.</p> <p>He also noted that <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000044079&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000044079&version=Patient&language=English">prospective studies</a> would need to be done to see whether patients with dMMR or MSI-H metastatic colorectal cancer who didn’t respond to checkpoint inhibitors, like pembrolizumab, that block the protein <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000777027&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000777027&version=Patient&language=English">PD-1</a> would respond to the addition of checkpoint inhibitors, like ipilimumab, that target the protein <a class="definition" onclick="javascript:popWindow('defbyid','CDR0000777030&version=Patient&language=English'); return false;" href="/Common/PopUps/popDefinition.aspx?id=CDR0000777030&version=Patient&language=English">CTLA-4</a>.</p> </div> </div> <footer class="article-footer"> <div id='cgov-blog-post-pagination' class='clearfix'> <div class='blog-post-older'> <a href="/news-events/cancer-currents-blog/2018/pembrolizumab-approved-fda-cervical-pmbcl">< Older Post</a> <p><i>New Immunotherapy Option Approved for Cervical Cancer, Rare Lymphoma</i></p> </div> <div class='blog-post-newer'> <a href="/news-events/cancer-currents-blog/2018/pi3k-resistance-ketogenic-diet-diabetes-drug">Newer Post ></a> <p><i>High-Fat Diet or Diabetes Drug May Enhance Response to Targeted Cancer Drug</i></p> </div> </div> <div id="nvcgSlPublicUse"> <div class="slot-item only-SI"> <div class="public-use"> <div id="block-ncids-trans-public-use"> <p><em>If you would like to reproduce some or all of this content, see <a href="/policies/copyright-reuse">Reuse of NCI Information</a> for guidance about copyright and permissions. 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href="/news-events/cancer-currents-blog?year=2022&month=09"> September </a> (6) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=08"> August </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=07"> July </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=06"> June </a> (8) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=05"> May </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=04"> April </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=03"> March </a> (8) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=02"> February </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2022&month=01"> January </a> (6) </li> </ul> <h3> 2021 </h3> <ul class="ui-helper-reset"> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=12"> December </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=11"> November </a> (4) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=10"> October </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=09"> September </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=08"> August </a> (6) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=07"> July </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=06"> June </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=05"> May </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=04"> April </a> (8) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=03"> March </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=02"> February </a> (5) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2021&month=01"> January </a> (6) </li> </ul> <h3> 2020 </h3> <ul class="ui-helper-reset"> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2020&month=12"> December </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2020&month=11"> November </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2020&month=10"> October </a> (8) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2020&month=09"> September </a> (6) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2020&month=08"> August </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2020&month=07"> July </a> (9) </li> <li class="month"> 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href="/news-events/cancer-currents-blog?year=2019&month=09"> September </a> (8) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=08"> August </a> (6) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=07"> July </a> (8) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=06"> June </a> (6) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=05"> May </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=04"> April </a> (7) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=03"> March </a> (10) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=02"> February </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2019&month=01"> January </a> (6) </li> </ul> <h3> 2018 </h3> <ul class="ui-helper-reset"> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=12"> December </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=11"> November </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=10"> October </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=09"> September </a> (11) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=08"> August </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=07"> July </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=06"> June </a> (12) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=05"> May </a> (9) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=04"> April </a> (10) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=03"> March </a> (11) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=02"> February </a> (11) </li> <li class="month"> <a href="/news-events/cancer-currents-blog?year=2018&month=01"> January </a> (10) </li> </ul> </div> </div> </div> </div> </div> </div>  </div> <section class="cgdp-page-options cgdp-page-options--bottom" aria-label="Page options bottom"> <button class="usa-button usa-button--unstyled" onclick="window.print()"> <svg xmlns="http://www.w3.org/2000/svg" height="24" viewBox="0 0 24 24" width="24" class="usa-icon" role="img" aria-hidden="true" focusable="false"> <path d="M0 0h24v24H0z" fill="none"/> <path d="M19 8H5c-1.66 0-3 1.34-3 3v6h4v4h12v-4h4v-6c0-1.66-1.34-3-3-3zm-3 11H8v-5h8v5zm3-7c-.55 0-1-.45-1-1s.45-1 1-1 1 .45 1 1-.45 1-1 1zm-1-9H6v4h12V3z"/> </svg> <span class="usa-sr-only"> Print </span> </button> <a class="usa-button usa-button--unstyled" 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