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Fathi, MD, Yi-Bin Chen, MD, Zachariah DeFilipp, MD, Areej El-Jawahri, MD and colleagues found in a phase 1 trial that enasidenib 100 mg/day was safe and well tolerated as maintenance therapy.." > <title>Enasidenib Well Tolerated After Stem Cell Transplantation for IDH2-Mutated Myeloid Malignancies - Mass General Advances in Motion</title> <link rel="canonical" href="https://advances.massgeneral.org/oncology/journal.aspx?id=2522"> <meta name="specialty-detail" content="Oncology|/oncology/specialty.aspx?id=1008"> <meta name="specialty" content="Oncology"> <meta name="pubDate" content="August 14, 2023"> <meta name="hubContentType" content="Journal"> <meta property="og:locale" content="en_US"> <meta property="og:url" content="https://advances.massgeneral.org/oncology/journal.aspx?id=2522"> <meta property="og:site_name" content="Mass General Advances in Motion"> <meta property="og:title" content="Enasidenib Well Tolerated After Stem Cell Transplantation for IDH2-Mutated Myeloid Malignancies"> <meta property="og:description" content="Amir T. 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for?</span> <span class="nav-search__label--mobile">Search</span> </label> <input type="search" id="site-search" value=""> <button class="fat-button"><span class="a11y-sr-only">Submit</span></button> </p> </div> </li> </ul> </nav> </header>    <main class="site-main" id="main-content" tabindex="-1"> <div id="panelMainContent"> <article dcrname ="iwDCR0_071300"> <header class="-padding--horizontal" itemscope itemtype="http://schema.org/ScholarlyArticle"> <div class="content-header content-container -width--wide -centered"> <div class="tags"> <ul class="tag__list"> <li class="tag__item"> <a class="tag__link" href="/oncology/specialty.aspx?id=1008">Oncology</a> </li> </ul> </div> <h1 class="content-header__heading" itemprop="name">Enasidenib Safe, Well Tolerated As Maintenance After Stem Cell Transplantation for IDH2-Mutated Myeloid Malignancies</h1> <div class="content-header__metadata"> <p class="content-metadata"> <span class="content-metadata__media -journal">Journal</span> <time class="date" datetime="2023-08-14" itemprop="datePublished">Published on August 14, 2023 </time> </p> <p data-module="share-links"> </p> <p class="citation"> Originally published on <cite itemprop="citation"><a href="https://www.sciencedirect.com/science/article/pii/S2473952922006255">Blood Advances</a></cite> </p> </div> </div> </header> <div class="-padding--vertical -padding--horizontal"> <div class="layout-columns -width--wide -centered"> <div class="layout-columns__main"> <div class="layout-columns__main__content"> <div class="content-summary"> <h3 class="content-summary__heading">Key findings</h3> <ul> <li>The primary objective of this phase 1, multicenter, dose-finding study was to define the recommended phase 2 dose of enasidenib as maintenance therapy following hematopoietic cell transplantation for <i>IDH2</i>-mutated myeloid malignancies</li> <li>Enasidenib was well tolerated at the doses studied, 50 and 100 mg/day, and 100 mg was deemed the recommended phase 2 dose</li> <li>11 of the 19 patients completed all 12 planned cycles, and only three patients stopped enasidenib because of adverse events deemed at least possibly related to treatment</li> <li>Grade 3 or higher toxicities were infrequent, with the most common being cytopenias</li> <li>Transient dose interruptions were required for eight patients, but dose reductions to 50 mg/day allowed most patients to continue and tolerate treatment</li> </ul> </div> <p>Enasidenib is FDA-approved for treatment of relapsed/refractory<span> </span><em>IDH2-</em>mutated acute myeloid leukemia (AML). Researchers at<span> </span><a title="Mass General Cancer Center" href="https://www.massgeneral.org/cancer-center">Mass General Cancer Center</a><span> </span>now show in<span> </span><a title="Enasidenib as maintenance following allogeneic hematopoietic cell transplantation for IDH2-mutated myeloid malignancies" href="https://www.sciencedirect.com/science/article/pii/S2473952922006255" target="_blank" rel="noopener noreferrer"><em>Blood Advances</em></a><span> </span>showing enasidenib is safe and well tolerated as maintenance therapy following allogeneic hematopoietic cell transplantation for<span> </span><em>IDH2-</em>mutated myeloid malignancies.</p><div class="article__signup-container"> <div class="email-signup-inline__container -background--white"> <style> #email-signup-inline { /* 540px */ background-image: url(/assets/raw/email-signup/cardiovascular-sub-callout.jpg); } @media only screen and (-webkit-min-device-pixel-ratio: 2), only screen and (min--moz-device-pixel-ratio: 2), only screen and (-moz-min-device-pixel-ratio: 2), only screen and (-o-min-device-pixel-ratio: 2/1), only screen and (min-device-pixel-ratio: 2), only screen and (min-resolution: 192dpi), only screen and (min-resolution: 2dppx) { #email-signup-inline { /* 1080 width */ background-image: url(/assets/raw/email-signup/cardiovascular-sub-callout.jpg); 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range, 37–90). Their median age was 63.</p> <p>Eight patients had newly diagnosed AML, seven had AML with myelodysplasia-related changes, two had AML arising from antecedent myeloproliferative neoplasms and two had myelodysplastic syndrome with excess blasts.</p> <p>Enasidenib was to be taken once daily for twelve 28-day cycles. The period for evaluation of dose-limiting toxicity was the first cycle.</p> <h2>Dose-Finding</h2> <p>Three patients were enrolled at 50 mg/day, followed by six at 100 mg/day. No dose-limiting toxicities were detected. Pursuant to the protocol 10 additional patients were enrolled at 100 mg/day, which has been deemed the recommended phase 2 dose.</p> <h2>Safety</h2> <p>Grade 3 adverse events considered possibly, probably or definitely treatment-related were anemia (n=2 patients), bilirubinemia (n=1), coronary ischemia (n=1), fatigue (n=1) and hyponatremia (n=1). One case of grade 4 treated-related neutropenia occurred.</p> <h2>Treatment Persistence</h2> <p>Notable observations about treatment persistence were:</p> <ul> <li>Dose interruptions—Nine separate episodes in eight patients, six cases of treatment-related toxicity and three of graft-versus-host disease</li> <li>Dose reductions to 50 mg—Required by six patients, none during the first cycle; all continued treatment</li> <li>Number of patients who received all 12 planned cycles—11</li> </ul> <h2>Outcomes</h2> <p>Accurate estimations of activity require larger studies, but the cumulative incidence of relapse was 16% and estimated progression-free survival and overall survival at two years were 69% and 74%, respectively.</p> <p>Although numbers are small and assessment of clinical activity requires larger studies, outcomes in this phase 1 study were encouraging and compared favorably to historical data.</p><p class="fat-link__wrapper u-text-right"> <a class="fat-link -caret -large" href="https://www.sciencedirect.com/science/article/pii/S2473952922006255">view original journal article <em>Subscription may be required</em></a> </p> <div class="article-attribution" itemscope itemtype="http://schema.org/ScholarlyArticle"> <p class="article-attribution__logo" itemscope itemtype="http://schema.org/Periodical"> <a href="https://www.sciencedirect.com/science/article/pii/S2473952922006255"> <span class="a11y-sr-only" itemprop="name">Blood Advances</span> </a> </p> <p class="article-attribution__metadata" itemscope itemtype="http://schema.org/PublicationIssue"> <span> Journal Article Published: <time datetime="2022-11-22" itemprop="datePublished">November 22, 2022</time> </span> </p> </div> <p class="cta">Learn about the <a href="https://www.massgeneral.org/cancer-center/treatments-and-services/leukemia">Center for Leukemia</a></p> <p class="cta">Refer a patient to the <a href="https://www.massgeneral.org/cancer-center/appointments-and-referrals">Mass General Cancer Center</a></p> </div> </div> <aside class="layout-columns__sidebar -article__contributors"> <div class="layout-columns__sidebar__content"> <div class="profile-compact__wrapper"> <p class="u-no-margin"> <strong>Contributors</strong> </p> <div class="profile -compact" itemscope itemtype="http://schema.org/Person"> <div class="profile__content"> <h3 class="profile__name" itemprop="name"> <a href="/contributors/contributor.aspx?id=2494" itemprop="url">Amir T. Fathi, MD ›</a></h3><p class="profile__title" itemprop="jobTitle">Program Director, Center for Leukemia, Mass General Cancer Center, Associate Professor of Medicine, Harvard Medical School</p> </div> </div> <div class="profile -compact" itemscope itemtype="http://schema.org/Person"> <div class="profile__content"> <h3 class="profile__name" itemprop="name"> <a href="/contributors/contributor.aspx?id=1553" itemprop="url">Areej R. El-Jawahri, MD ›</a></h3><p class="profile__title" itemprop="jobTitle">Hematologist, Mass General Cancer Center, Assistant in Medicine, Massachusetts General Hospital, Instructor in Medicine, Harvard Medical School</p> </div> <p class="profile__image"> <img alt="" itemprop="image" srcset="/assets/images/contributors/areej_el_jawahri_advances.png, /assets/images/contributors/areej_el_jawahri_advances_2x.png 2x" src="/assets/images/contributors/areej_el_jawahri_advances.png"> </p> </div> <div class="profile -compact" itemscope itemtype="http://schema.org/Person"> <div class="profile__content"> <h3 class="profile__name" itemprop="name"> <a href="/contributors/contributor.aspx?id=2496" itemprop="url">Yi-Bin Chen, MD ›</a></h3><p class="profile__title" itemprop="jobTitle">Director, Hematopoietic Cell Transplant & Cell Therapy Program, Allen B. Rogers, Jr. and Cara J. Rogers Endowed Chair, Massachusetts General Hospital, Professor of Medicine, Harvard Medical School</p> </div> </div> <div class="profile -compact" itemscope itemtype="http://schema.org/Person"> <div class="profile__content"> <h3 class="profile__name" itemprop="name"> <a href="/contributors/contributor.aspx?id=2495" itemprop="url">Zachariah DeFilipp, MD ›</a></h3><p class="profile__title" itemprop="jobTitle">Director, Clinical Research, Bone Marrow Transplant Program, Mass General Cancer Center, Assistant Professor of Medicine, Harvard Medical School</p> </div> </div> </div> </div> </aside> <section class="-padding--horizontal -padding--vertical -article__related"> <div class="layout-columns -width--wide -centered"> <div class="layout-columns__pod--half"> <div class="content-tease" itemscope itemtype="http://schema.org/ScholarlyArticle"> <p class="content-tease__topic"> <span class="highlight">Related</span> </p> <h3 class="content-tease__heading" itemprop="name"> <a href="/oncology/journal.aspx?id=2345" itemprop="url">Combination Strategy Potentiates CAR T-cell Therapy for Acute Myeloid Leukemia</a> </h3> <p itemprop="description"> <p><span>Acute myeloid leukemia has been challenging to treat with CAR T-cell therapy. Still, Marcela V. Maus, MD, PhD, Mark B. 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Fathi, MD, Yi-Bin Chen, MD, Zachariah DeFilipp, MD, Areej El-Jawahri, MD and colleagues found in a phase 1 trial that ivosidenib was safe and well tolerated as maintenance therapy for acute myeloid leukemia following allogeneic hematopoietic cell transplantation, and two-year outcomes were promising.</span></p></p> <p class="content-tease__related"> <a href="/oncology/specialty.aspx?id=1008" itemprop="relatedLink">Oncology</a> </p> <p class="content-metadata"> <span class="content-metadata__media -journal">Journal</span> <time class="date" datetime="2023-08-10" itemprop="datePublished">August 10, 2023</time> </p> </div> </div> </div> </section> </div> </div> </article> </div> </main>  <footer class="site-footer"> <div class="-padding--horizontal"> <nav aria-label="Footer links" class="content-container -width--wide -centered -padding--bottom"> <ul class="footer__nav" role="presentation"> <li> <a href="https://www.massgeneral.org/about">About Mass General</a> </li> <li> <a 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