On Tuesday, Syndax Prescribed drugs Inc SNDX revealed topline outcomes from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort within the pivotal Part 2 portion of the AUGMENT-101 trial of revumenib.
The cohort met the first endpoint with an entire remission (CR) plus CR with a partial hematological restoration (CRh) price of 23% among the many efficacy evaluable adults.
Additionally Learn: FDA Approves Incyte/Syndax Partnered Drug For Persistent Graft-Versus-Host Illness, A Put up-Transplant Complication
Among the many sufferers who achieved CR/CRh, 12 had a CR, and three had a CRh.
On the information cutoff, the noticed median period of CR/CRh responses was 4.7 months, with three sufferers remaining in response.
Minimal residual illness (MRD) standing was assessed in 14 of 15 sufferers who achieved CR/CRh, 64% (9/14) of whom have been MRD detrimental. The general response price (ORR) was 47%.
17% of sufferers who achieved an total response underwent hematopoietic stem cell transplant (HSCT) following therapy with revumenib, with three resuming revumenib remedy post-transplant.
The security inhabitants included 84 grownup and pediatric sufferers with R/R mNPM1 AML within the Part 2 portion of the AUGMENT-101 trial.
The security profile noticed with revumenib on this inhabitants was in keeping with beforehand reported information.
Remedy-related opposed occasions (TRAEs) resulting in therapy discontinuations have been 5%
The corporate is conducting a number of trials of revumenib throughout the therapy panorama in mNPM1 and KMT2A-rearranged (KMT2Ar) acute leukemias.
Syndax expects to attain the next upcoming revumenib milestones:
- Obtain FDA approval for R/R KMT2Ar acute leukemias within the fourth quarter of 2024.
- Provoke a pivotal mixture trial with venetoclax/azacitidine in newly recognized mNPM1 AML or KMT2Ar acute leukemias by year-end 2024.
- Publish pivotal AUGMENT-101 ends in R/R mNPM1 AML sufferers and current outcomes at a medical convention within the first half of 2025.
- Submit a supplemental NDA for R/R mNPM1 AML within the first half of 2025.
Worth Motion: SNDX inventory is down 22.1% at $16.96 ultimately verify Tuesday.
Learn Subsequent:
Market Information and Knowledge dropped at you by Benzinga APIs
© 2024 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.
