Syndax Pharmaceuticals Announces Two Publications in Nature of Data from the Phase 1 Portion of AUGMENT-101 in Acute Leukemia Patients

Excerpt from the Press Release:

WALTHAM, Mass., March 15, 2023 /PRNewswire/ — Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) today announced that 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 (KMT2Ar) relapsed/refractory (R/R) acute leukemia and an analysis describing MEN1 mutations observed in the study have been published in the journal Nature. Revumenib is the Company’s highly selective, oral menin inhibitor.

The Phase 1 publication entitled “The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia” includes positive data from 68 patients with R/R acute leukemia evaluable for safety, 60 patients of whom had mNPM1 or KMT2Ar acute leukemia and were evaluable for efficacy. In these heavily pretreated patients with a median of four prior therapies, 30% (18/60) experienced a CR/CRh with a median duration of CR/CRh response of 9.1 months. Revumenib was well-tolerated, and there were no discontinuations due to treatment-related adverse events. The Phase 1 data were recently featured in two oral presentations at the 64^th American Society of Hematology Annual Meeting.

“We are excited to have our Phase 1 AUGMENT-101 data published in such a prominent peer-reviewed journal. As we continue to deepen our understanding of the tumor biology driven by the menin-KMT2A interaction, we gain more evidence to support the potential of revumenib as a best-in-class treatment for both mNPM1 and KMT2Ar acute leukemias,” said Michael A. Metzger, Chief Executive Officer.

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