Verastem, Inc. 8-K

What Happened
Verastem, Inc. announced (press release dated Dec. 29, 2025; 8‑K filed Dec. 31, 2025) that it will discontinue the RAMP 203 Phase 1/2 clinical trial in advanced KRAS G12C-mutated non‑small cell lung cancer (NSCLC). The company said there will be no further enrollment; currently enrolled patients may continue treatment at investigator discretion. The decision follows an interim data review (data cutoff Nov. 26, 2025) and reflects a strategic reallocation of resources to VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, for development in advanced NSCLC and other solid tumors.

Key Details

• 66 patients treated at the recommended Phase 2 dose were evaluable for efficacy as of the Nov. 26, 2025 data cutoff.
• Doublet (avutometinib + sotorasib) — treatment‑naïve: 30 evaluable patients, ORR 40% (12/30), median PFS 11.1 months (median follow‑up 15.9 months). Previously treated: 21 evaluable, ORR 9.5% (2/21), median PFS 3.7 months (median follow‑up 10.8 months).
• Triplet (avutometinib + sotorasib + defactinib) — treatment‑naïve: 6 patients enrolled, 4 evaluable, ORR 50% (2/4; one confirmed, one unconfirmed) with one additional patient achieving stable disease. Previously treated: 12 enrolled, 11 evaluable; 4 (36%) had >30% tumor reduction and 7 remained on treatment at cutoff. Median PFS was not reached in the triplet treatment‑naïve cohort; triplet previously treated median PFS 3.6 months.
• Safety: no dose‑limiting toxicities observed across cohorts. Most common treatment‑related adverse events were nausea (56.8%), diarrhea (52.7%) and fatigue (45.9%).
• RAMP 203 was conducted in collaboration with Amgen and tested avutometinib (RAF/MEK clamp) in doublet and triplet combinations with LUMAKRAS™ (sotorasib) and defactinib.

Why It Matters
This is material because Verastem is stopping enrollment in an ongoing clinical program and redirecting clinical development resources to a different asset (VS-7375). Investors should note the concrete efficacy and safety readouts reported from the interim analysis (ORRs, PFS, patient counts) and that ongoing patients may continue per investigator discretion. The move signals a strategic prioritization by management toward a KRAS G12D program and away from further investment in this KRAS G12C combination trial, which could affect near‑term development milestones, cash burn allocation and the company’s clinical pipeline focus. The filing also includes standard forward‑looking statement cautions.