Syndax Highlights Durable Remissions For Revumenib In Acute Leukemia Patients

Syndax Pharmaceuticals Inc SNDX announced updated data from the Phase 1 portion of the ongoing Phase 1/2 AUGMENT-101 trial of revumenib in patients with nucleophosmin (NPM1) mutant and mixed lineage leukemia rearranged (MLLr) relapsed/refractory (R/R) acute leukemias.
As of the March 2022 data cutoff date, sixty patients were efficacy evaluable. The overall response rate (ORR) was 53% (32/60), with a CR/CRh rate of 30% (18/60).
There were no discontinuations due to treatment-related adverse events, and the median duration of response was 9.1 months.
Revumenib was well-tolerated, and no new safety signals were identified in the trial.
Across evaluable patients with mNPM1 (n=14) or MLLr (n=46) acute leukemia who received revumenib, 12 (20%) patients proceeded to stem cell transplant, ten (83%) of whom were minimal residual disease-negative.
Nine of the 12 patients (75%) who received a stem cell transplant remained in remission, with a median follow-up of 12.3 months, and four patients experienced remission for longer than one year.
Three patients were treated in the compassionate use setting with revumenib maintenance following stem cell transplant or non-myeloablative stem cell boost, two (67%) remaining in remission for over one year.
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