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Syndax Presents Positive Revuforj® (revumenib) Data in Acute Leukemias from Multiple Trials, Including the SAVE Combination and AUGMENT-101 Trials, at 66th ASH Annual Meeting
– 82% ORR (27 of 33 pts) and 48% CR/CRh (16 of 33 pts) in SAVE trial studying revumenib in combination with venetoclax and decitabine/cedazuridine in R/R AML
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– 82% ORR (27 of 33 pts) and 48% CR/CRh (16 of 33 pts) in SAVE trial studying revumenib in combination with venetoclax and decitabine/cedazuridine in R/R AML –\n– 64% ORR (62 of 97 pts) and 23% CR/CRh (22 of 97 pts) with high rates of MRD negativity and ability to proceed to HSCT in expanded dataset of Ph 2 R/R KMT2Ar acute leukemia patients in AUGMENT-101 –\n– Responses were rapid, durable and observed across all major subgroups in expanded dataset ofPh 2 R/R KMT2Ar acute leukemia patients in AUGMENT-101 – \n– Latest data highlight the compelling clinical profile of revumenib and support advancement into combination trials in the frontline setting –\nWALTHAM, Mass., Dec. 7, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presented positive data from multiple trials of Revuforj® (revumenib) as a single-agent and in combination with standard of care agents in patients with acute leukemias in oral sessions at the 66th American Society of Hematology (ASH) Annual Meeting being held in San Diego, December 7-10, 2024. Revuforj is the Company's oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.\n\n\"On the heels of the recent approval of Revuforj for R/R acute leukemia with a KMT2A translocation, we are excited to present clinical data highlighting the consistent efficacy and favorable tolerability of this first-in-class therapy, as both a single-agent and in combination with standard of care, in patients with mNPM1 and KMT2Ar acute leukemia,\" said Michael A. Metzger, Chief Executive Officer. \"We are thrilled that our U.S. launch of Revuforj is firmly underway, and we look forward to building on this momentum as we continue to advance our clinical development program which we believe will position us to pursue meaningful label expansion opportunities.\"\nOverview of Revumenib Data Presented in Oral Sessions at 66th ASH Annual Meeting\nResults from Phase 1/2 SAVE Trial of Revumenib in Combination with Venetoclax and Decitabine/Cedazuridine in R/R AML\nThe Phase 1/2 SAVE trial is an investigator-sponsored trial testing an all-oral regime...