secwatch.observer — SEC 8-K summary
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Issuer:     Verastem, Inc. (VSTM)
CIK:        0001526119
Form:       8-K
Filed at:   2024-10-17T23:59:59+00:00
Accession:  0001104659-24-109439
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Verastem reports 31% ORR with avutometinib/defactinib in RAMP 201; NDA submission ongoing
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- Confirmed ORR of 31% overall (44% KRAS mutant, 17% KRAS wild type) by BICR.
- Median duration of response 31.1 months; median PFS 12.9 months overall.
- Discontinuation rate due to AEs was 10%; safety manageable with dose modifications.
- Low-dose regimen (1.6 mg avutometinib) suboptimal; 22% progressed within 4 months vs 12% at 3.2 mg.
- Rolling NDA submission to FDA for avutometinib+defactinib in recurrent LGSOC is underway.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924109439/0001104659-24-109439-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924109439/tm2426322d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-109439

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