SNDX - Syndax's SNDX-5613 shows robust clinical activity in patients with acute leukemias

Syndax Pharmaceuticals (SNDX) announces updated positive data from Phase 1 dose escalation portion of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias.As of a March 12, 2021 data cutoff date, 43 patients with a median of three prior therapies, were dosed in Phase 1 portion of the trial.The overall response rate ((ORR)) among evaluable patients (n=31) was 48% (n=15), with 67% of these responders achieving minimal residual disease ((MRD)) negative status, with four of these patients proceeding to receive stem cell transplant.The ORR in evaluable patients harboring an MLL-rearrangement (n=24), was 54% (n=13), and in evaluable patients harboring an NPM1c mutation (n=7), was 29% (n=2).Eighteen patients treated at the RP2D were efficacy-evaluable and response results observed at the RP2D were consistent with the overall population.SNDX-5613 was generally well-tolerated, with no discontinuations due to treatment-related adverse events.

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Syndax's SNDX-5613 shows robust clinical activity in patients with acute leukemias