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Syndax Announces Positive Updated Data from Phase 1 Portion of AUGMENT-101 Trial of Revumenib in Patients with Acute Leukemias During Oral Presentations at 64th ASH Annual Meeting
- 30% CR/CRh rate in efficacy evaluable population; 27% CR/CRh rate observed in both mNPM1 and KMT2Ar (MLLr) R/R acute leukemia patients treated at RP2D - - 9
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- 30% CR/CRh rate in efficacy evaluable population; 27% CR/CRh rate observed in both mNPM1 and KMT2Ar (MLLr) R/R acute leukemia patients treated at RP2D -\n- 9 of 12 patients who underwent stem cell transplant after achieving a response with revumenib remained in remission, with four continuing beyond one year -\n- Company to host conference call and webcast on Sunday, December 11, 2022 at 8:00 a.m. CT/ 9:00 a.m. ET -\nWALTHAM, Mass., Dec. 10, 2022 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presented updated positive data from the Phase 1 portion of the ongoing Phase 1/2 AUGMENT-101 trial of revumenib in patients with nucleophosmin mutant (mNPM1) and KMT2A rearranged (KMT2r) relapsed/refractory (R/R) acute myeloid or acute lymphoid leukemias (ALL or AML). Revumenib is the Company's highly selective, oral menin inhibitor. The data were featured during two oral sessions today at the 64th American Society of Hematology (ASH) Annual Meeting.\n\"Both AUGMENT-101 data presentations featured today at the ASH Annual Meeting highlight revumenib's compelling clinical profile and continue to support the potential for revumenib to be a first-in-class and best-in-class therapy for both KMT2Ar and NPM1 acute leukemias,\" said Michael A. Metzger, Chief Executive Officer. \"We previously announced that revumenib received Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia (AML or ALL) harboring KMT2A rearrangements, further emphasizing the compelling data that we have generated in the Phase 1 portion of the trial that included 46 R/R KMT2Ar acute leukemia patients as well as the unmet need that exists in this population. We remain on track to report top-line data from at least one of the cohorts from the pivotal Phase 2 portion of the trial beginning in the third quarter of 2023, followed by a potential New Drug Application filing by the end of 2023.\"\n\"Patients with genetically-defined acute leukemias, including those harboring NPM1 mutations and KMT2A-rearrangements, have a limited number of effective treatment options and face a particularly poor prognosis,\" said Ghayas C. Issa, M.D., Assistant Professor, Department of Leukemia, Division of Cancer Medicine, The Uni...