---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-064919"
form_type: "8-K"
ticker: "VSTM"
cik: "0001526119"
company_name: "Verastem, Inc."
filed_at: "2024-05-24T23:59:59+00:00"
generated_at: "2026-06-01T08:41:36.786062+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-064919
- form_type: 8-K
- ticker: VSTM
- cik: 0001526119
- company_name: Verastem, Inc.
- filed_at: 2024-05-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1526119/000110465924064919/0001104659-24-064919-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1526119/000110465924064919/tm2415352d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-064919
- JSON: https://secwatch.observer/filing/0001104659-24-064919.json
- Plain text: https://secwatch.observer/filing/0001104659-24-064919.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.