{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T03:39:45Z","timestamp":1794281985576,"version":"4.9.0"},"reference-count":41,"publisher":"American Society of Hematology","issue":"9","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,8,28]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>The prognosis for relapsed or refractory (R\/R) nucleophosmin 1\u2013mutated (NPM1m) acute myeloid leukemia (AML) is poor and represents an urgent unmet medical need. Revumenib, a potent, selective menin inhibitor, was recently approved for the treatment of R\/R acute leukemia with a KMT2A translocation in patients aged \u22651 year based on results from the phase 1\/2 AUGMENT-101 study. Here, we present results from patients with R\/R NPM1m AML enrolled in the phase 2 portion of AUGMENT-101. Enrolled patients received revumenib with or without a strong CYP3A4 inhibitor every 12 hours in 28-day cycles. Primary end points were rate of complete remission (CR) or CR with partial hematologic recovery (CRh; CR + CRh), safety, and tolerability. Secondary end points included overall response rate (ORR) and duration of response. As of 18 September 2024, 84 patients received \u22651 dose of revumenib. Median age was 63 years; 1 patient was aged &amp;lt;18 years. The protocol-defined, efficacy-evaluable population for the primary analysis included 64 adult patients (\u22653 previous lines of therapy, 35.9%; previous venetoclax, 75.0%). The CR + CRh rate was 23.4% (1-sided P = .0014); the ORR was 46.9%. Median duration of CR + CRh was 4.7 months. Of 30 responders, 5 (16.7%) proceeded to hematopoietic stem cell transplant (HSCT) and 3 resumed revumenib after HSCT. Treatment-related adverse events led to treatment discontinuation in 4 patients (4.8%). Revumenib demonstrated clinically meaningful responses in this heavily pretreated, older population with NPM1m AML, including remissions that enabled HSCT. The safety profile of revumenib was consistent with previously reported results. This trial was registered at www.clinicaltrials.gov as #NCT04065399.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025028357","type":"journal-article","created":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T10:15:20Z","timestamp":1746612920000},"page":"1065-1077","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":93,"title":["Menin inhibition with revumenib for\n                    <i>NPM1<\/i>\n                    -mutated relapsed or refractory acute myeloid leukemia: the AUGMENT-101 study"],"prefix":"10.1182","volume":"146","author":[{"given":"Martha L.","family":"Arellano","sequence":"first","affiliation":[{"name":"1Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University School of Medicine, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Thirman","sequence":"additional","affiliation":[{"name":"2Department of Medicine, Section of Hematology and Oncology, The University of Chicago Medicine, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John F.","family":"DiPersio","sequence":"additional","affiliation":[{"name":"3Department of Medicine, Washington University School of Medicine, St Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1682-8657","authenticated-orcid":false,"given":"Ma\u00ebl","family":"Heiblig","sequence":"additional","affiliation":[{"name":"4Hematology Department, Centre Hospitalier Lyon Sud, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eytan M.","family":"Stein","sequence":"additional","affiliation":[{"name":"5Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre C.","family":"Schuh","sequence":"additional","affiliation":[{"name":"6Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre and University of Toronto, Toronto, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrius","family":"\u017du\u010denka","sequence":"additional","affiliation":[{"name":"7Faculty of Medicine, Hematology and Oncology Department, Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8126-4942","authenticated-orcid":false,"given":"Stephane","family":"de Botton","sequence":"additional","affiliation":[{"name":"8Hematologie Clinique, Institut Gustave Roussy, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2788-9893","authenticated-orcid":false,"given":"Carolyn S.","family":"Grove","sequence":"additional","affiliation":[{"name":"9Department of Haematology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia"},{"name":"10Department of Haematology, PathWest Inc, Nedlands, WA, Australia"},{"name":"11Department of Haematology, University of Western Australia, Nedlands, WA, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel N.","family":"Mannis","sequence":"additional","affiliation":[{"name":"12Division of Hematology, Stanford University School of Medicine, Stanford, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8705-8333","authenticated-orcid":false,"given":"Cristina","family":"Papayannidis","sequence":"additional","affiliation":[{"name":"13IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia \u201cSer\u00e0gnoli,\u201d Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1463-2231","authenticated-orcid":false,"given":"Alexander E.","family":"Perl","sequence":"additional","affiliation":[{"name":"14Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4339-8683","authenticated-orcid":false,"given":"Ghayas C.","family":"Issa","sequence":"additional","affiliation":[{"name":"15Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim","family":"Aldoss","sequence":"additional","affiliation":[{"name":"16Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish","family":"Bajel","sequence":"additional","affiliation":[{"name":"17Department of Haematology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia"},{"name":"18Department of Haematology, The Royal Melbourne Hospital, Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8821-6022","authenticated-orcid":false,"given":"David S.","family":"Dickens","sequence":"additional","affiliation":[{"name":"19Division of Pediatric Hematology\/Oncology, University of Iowa Stead Family Children\u2019s Hospital, Iowa City, IA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael W. M.","family":"K\u00fchn","sequence":"additional","affiliation":[{"name":"20Department of Hematology and Oncology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioannis","family":"Mantzaris","sequence":"additional","affiliation":[{"name":"21Department of Oncology, Montefiore Einstein Comprehensive Cancer Center, Bronx, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Raffoux","sequence":"additional","affiliation":[{"name":"22Adult Hematology Department, Hospital Saint Louis, Universit\u00e9 Paris Diderot, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8844-2345","authenticated-orcid":false,"given":"Elie","family":"Traer","sequence":"additional","affiliation":[{"name":"23Division of Hematology\/Medical Oncology, Oregon Health & Science University, Knight Cancer Institute, Portland, OR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Amitai","sequence":"additional","affiliation":[{"name":"24Hematology Division, Chaim Sheba Medical Center, Tel Hashomer, Israel"},{"name":"25School of Medicine, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2116-5536","authenticated-orcid":false,"given":"Hartmut","family":"D\u00f6hner","sequence":"additional","affiliation":[{"name":"26Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corinna","family":"Greco","sequence":"additional","affiliation":[{"name":"27Division of Hematology, Ospedale San Bortolo, Aulss Berica, Vicenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tibor","family":"Kovacsovics","sequence":"additional","affiliation":[{"name":"28Department of Hematology and Hematopoietic Cell Transplantation, City of Hope Phoenix, Goodyear, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9745-9595","authenticated-orcid":false,"given":"Christine M.","family":"McMahon","sequence":"additional","affiliation":[{"name":"29Department of Hematology, University of Colorado School of Medicine, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3275-5593","authenticated-orcid":false,"given":"Pau","family":"Montesinos","sequence":"additional","affiliation":[{"name":"30Hematology Department, Hospital Universitari i Polit\u00e8cnic La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Pigneux","sequence":"additional","affiliation":[{"name":"31Hematology Department, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul J.","family":"Shami","sequence":"additional","affiliation":[{"name":"32Division of Hematology and Hematologic Malignancies, University of Utah Huntsman Cancer Institute, Salt Lake City, UT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard M.","family":"Stone","sequence":"additional","affiliation":[{"name":"33Department of Medical Oncology, Division of Leukemia, Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ofir","family":"Wolach","sequence":"additional","affiliation":[{"name":"25School of Medicine, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel"},{"name":"34Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petach Tikva, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John G.","family":"Harpel","sequence":"additional","affiliation":[{"name":"35ICON plc, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yakov","family":"Chudnovsky","sequence":"additional","affiliation":[{"name":"36Syndax Pharmaceuticals, Inc, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Yu","sequence":"additional","affiliation":[{"name":"36Syndax Pharmaceuticals, Inc, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca G.","family":"Bagley","sequence":"additional","affiliation":[{"name":"36Syndax Pharmaceuticals, Inc, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela R.","family":"Smith","sequence":"additional","affiliation":[{"name":"36Syndax Pharmaceuticals, Inc, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4275-5562","authenticated-orcid":false,"given":"James S.","family":"Blachly","sequence":"additional","affiliation":[{"name":"37Division of Hematology, Department of 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