Verastem initiates rolling NDA for avutometinib+defactinib in recurrent LGSOC; ORR 27%

Verastem, Inc.

Rolling NDA submission for avutometinib + defactinib in recurrent LGSOC started H2 2024; potential FDA approval in 2025.
RAMP 201 trial (Feb 2024 cutoff): ORR 27% overall (95% CI 19%-36%), 37% KRAS mt, 15% KRAS wt.
Clinical benefit rate (CR+PR+SD≥6 months) 60%; discontinuation due to AEs only 9%.
No FDA-approved treatments for LGSOC; SoC studies show ORR 6-13% with 17-30% discontinuation.
Market opportunity: $1.7B+ prevalent KRAS mt addressable; 70% of oncologists surveyed would adopt within 6 months of approval.

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