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Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials
- Data collectively highlight revumenib's combination potential with current standard of care agents and support advancement into pivotal combination trials
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Data collectively highlight revumenib's combination potential with current standard of care agents and support advancement into pivotal combination trials in the frontline setting -\n- 100% CRc observed in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML -\n-78% CRc observed in SAVE AML trial, an all-oral combination of revumenib, venetoclax and decitabine/cedazuridine in R/R mNPM1, NUP98r and KMT2Ar AML; five of nine patients continue in remission, 2 beyond 11 months at the time of the data cut -\n- 33% CRc observed in AUGMENT-102 trial of revumenib in combination with fludarabine-cytarabine in pediatric R/R mNPM1, NUP98r and KMT2Ar AML - \n- Revumenib was well tolerated with no new safety signals identified beyond those observed with the respective SOC combinations -\nWALTHAM, Mass., Dec. 11, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced data from multiple trials of revumenib in combination with standard of care agents in patients with nucleophosmin mutant (mNPM1) and KMT2A-rearranged (KMT2r) relapsed/refractory (R/R) acute leukemias. Revumenib is the Company's highly selective, oral menin inhibitor. \n\nData to date demonstrate that revumenib has been well tolerated and demonstrated clinical activity in combination with venetoclax/hypomethylating agents in both the frontline and R/R acute myeloid leukemia (AML) settings, as well as in combination with fludarabine/cytarabine (FLA) chemotherapy in a heavily pretreated R/R pediatric AML population, including in patients who relapsed on FLA. In all three trials, patients are now receiving the full monotherapy recommended Phase 2 dose in combination with the standard of care agents. The new combination data collectively highlight revumenib's potential to safely combine with current standard of care agents across the acute leukemia treatment landscape, and support expansion of ongoing trials and advancement into additional combination trials currently in planning. \n\"Given the urgent need for novel, effective solutions for acute leukemia patients, we're excited to show clinical data demonstrating tolerability and compelling clinical responses when revumenib is added to current treatment...