Syndax Reports Protocol-Defined Pooled Analysis Results from the (AUGMENT-101) Trial of Revumenib for Relapsed/Refractory KMT2Ar Acute Leukemia
Shots:
- The trial evaluating revumenib in adult & pediatric patients with r/r KMT2Ar AML and ALL which met its 1EPs & showed CR or a CR with CRh rate of 23% in 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia cohort & 24.5% in KMT2Ar AML
- CR/CRh responses in the overall population & AML subset were durable with a 6.4mos. median duration, 46% continuing in remission, 70% were MRD-ve. In the efficacy-evaluable patients, the ORR (63%), response underwent HSCT (39%), 18 patients did not achieve a CR or CRh before the transplant
- 50% of transplanted patients have initiated & 21% initiated revumenib as post-transplant, TRAEs leading to dose reductions & treatment discontinuation were low at 9% & 6%, respectively. The company plans to submit an NDA for revumenib to the US FDA in Q4’23
Ref: PR Newswire | Image: Syndax
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