SpringWorks Published P-III Trial (DeFi) Results of Nirogacestat for Desmoid Tumors in the NEJM
Shots:
- The P-III trial (DeFi) evaluating nirogacestat (gamma-secretase inhibitor) vs PBO in a ratio (1:1) in 142 patients. The trial met its 1EPs of improving PFS & improvement over PBO, 71% reduction in risk of disease progression, m-PFS (not reached vs 15.1mos.)
- Improved PFS across pre-specified subgroups, ORR (41% vs 8%); CR rate (7% vs 0%), clinical improvements in PROs, reduced pain & other desmoid tumor-specific symptoms at Cycle 10, improved physical/role functioning, overall health-related QoL
- As data cutoff on Apr 2022, the median follow-up for PFS was 15.9mos., manageable safety profile with 95% of all TEAEs reported as grade 1 or 2. Nirogacestat received FTD & BTD in the US for desmoid tumors or deep fibromatosis; ODD from the US FDA for desmoid tumors & from the EC for STS
Ref: Globenewswire | Image: SpringWorks Therapeutics
Related News:- SpringWorks Therapeutics Reports the US FDA Acceptance of NDA and Granted Priority Review of Nirogacestat for Desmoid Tumors
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