secwatch.observer — SEC 8-K summary
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Issuer:     Verastem, Inc. (VSTM)
CIK:        0001526119
Form:       8-K
Filed at:   2024-06-26T23:59:59+00:00
Accession:  0001104659-24-074956
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924074956/0001104659-24-074956-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924074956/tm2418267d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-074956

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer