Syndax Pharma AUGMENT-101 Trial Of Revumenib In Acute Leukemia Meets Key Goal

(RTTNews) - Syndax Pharmaceuticals (SNDX) Monday said its pivotal AUGMENT-101 study of Revumenib in patients with acute leukemia met its primary goal.

The Phase 2 portion of Phase 1/2 AUGMENT-101 study enrolled patients with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML), KMT2A-rearranged (KMT2Ar) AML and acute lymphoid leukemia (ALL).

The trial met its primary endpoint at the protocol-defined interim analysis stage with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% in patients with KMT2Ar acute leukemia. The CR/CRh rate in patients with KMT2Ar AML was 24.5%. Further, The CR/CRh responses in both the overall population and the AML subset were durable with a 6.4-month median duration as of data cut-off, with 46% remaining in response.

The company said that as per Independent Data Monitoring Committee (IDMC) recommendation, it is stopping the trial to further accrual in the KMT2Ar cohorts.

Syndax said it continues to expect to submit a New Drug Application for Revumenib for the treatment of R/R KMT2Ar acute leukemia to the FDA.