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Syndax Prescription drugs Inc SNDX introduced topline information from the AUGMENT-101 trial of revumenib in grownup and pediatric sufferers with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL).
The AUGMENT-101 trial met its main endpoint with an entire remission (CR) or a CR with partial hematological restoration (CRh) fee of 23% (13/57) among the many 57 efficacy evaluable sufferers within the pooled KMT2Ar acute leukemia cohort.
The CR/CRh fee in sufferers with KMT2Ar AML was 24.5% (12/49).
The CR/CRh responses within the general inhabitants and the AML subset had been sturdy, with a 6.4-month median length as of the July 24, 2023 information cut-off, with 46% (6/13) remaining in response.
Minimal residual illness (MRD) standing was assessed in 10 of the 13 sufferers who achieved a CR/CRh, 70% (7/10) of whom had been MRD destructive.
Within the efficacy-evaluable sufferers, the general response fee was 63%. 14 (39%) sufferers who achieved an general response underwent a hematopoietic stem cell transplant (HSCT), eight of whom didn’t obtain a CR or CRh earlier than the transplant.
Half (7/14) of the sufferers who had an HSCT acquired post-transplant upkeep with revumenib, and three extra sufferers (3/14; 21%) had been in follow-up and are eligible to restart revumenib as post-transplant upkeep.
Primarily based on the Unbiased Information Monitoring Committee (IDMC) advice, the corporate is stopping the trial to additional accrual within the KMT2Ar cohorts.
Value Motion: SNDX shares are down 9.09% at $13.20 on the final test Monday.
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