secwatch.observer — SEC 8-K summary
======================================

Issuer:     Verastem, Inc. (VSTM)
CIK:        0001526119
Form:       8-K
Filed at:   2024-05-24T23:59:59+00:00
Accession:  0001104659-24-064919
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Verastem initiates rolling NDA to FDA for avutometinib/defactinib in KRAS mutant LGSOC
--------------------------------------------------------------------------------

- Rolling submission of NDA seeking accelerated approval for recurrent KRAS mt LGSOC; initial sections include nonclinical and quality.
- Clinical module to be submitted in H2 2024 with mature RAMP 201 data including 12-month follow-up; priority review to be requested.
- As of Feb 2024 data cutoff: confirmed ORR by BICR 27% overall, 37% (KRAS mt, n=57) and 15% (KRAS wt, n=52); 60% clinical benefit rate ≥6 months.
- Discontinuation due to AEs was 9%; median duration of therapy in Part A: 11 months overall, 18 months KRAS mt, 8 months KRAS wt.
- No FDA-approved treatments exist for recurrent LGSOC; company plans focused commercial launch targeting top 400 HCPs with 14-18 reps.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924064919/0001104659-24-064919-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924064919/tm2415352d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-064919

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