---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-074956"
form_type: "8-K"
ticker: "VSTM"
cik: "0001526119"
company_name: "Verastem, Inc."
filed_at: "2024-06-26T23:59:59+00:00"
generated_at: "2026-06-01T01:29:01.105082+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-074956
- form_type: 8-K
- ticker: VSTM
- cik: 0001526119
- company_name: Verastem, Inc.
- filed_at: 2024-06-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1526119/000110465924074956/0001104659-24-074956-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1526119/000110465924074956/tm2418267d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-074956
- JSON: https://secwatch.observer/filing/0001104659-24-074956.json
- Plain text: https://secwatch.observer/filing/0001104659-24-074956.txt

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