Syndax Publishes the Pivotal AUGMENT-101 Study Data of Revumenib for R/R KMT2Ar Acute Leukemia in the Journal of Clinical Oncology
Shots:
- Syndax has published the data (as of Jul 2023) from AUGMENT-101 study’s P-II part of revumenib for r/r KMT2Ar AML & ALL patients (n=94) in the JCO. Results formed the basis of NDA that received the US FDA’s priority review (PDUFA: Dec 26, 2024)
- Study showed, CR or CRh rate: 23% (n=57) in both adult & pediatric patients; median time to CR + CRh: 1.9mos., median duration: 6.4mos. (46% remained in response); 70% were MRD -ve. In the efficacy-evaluable patients, ORR: 63%; CRc: 44%; MRD was -ve in 68% of those achieving CRc; 39% of those achieving overall response underwent HSCT (50% of them resumed revumenib); mOS: 8mos.
- The recruitment is completed in final AUGMENT-101 arm for r/r mNPM1 AML; topline data is anticipated in Q4’24 to support the sNDA filing in H1’25
Click here to read the full press release
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
