Verastem, Inc. Form 8-K Summary
Business Context and Reporting Period
This Current Report on Form 8-K was filed by Verastem, Inc. on June 23, 2026. The filing discloses preliminary data from the ongoing TARGET-D 101 Phase 1/2 clinical trial evaluating VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor, and announces an intent to collaborate with Erasca, Inc. to evaluate VS-7375 in combination with Erasca's ERAS-0015.
Key Financial Metrics
The filing text does not provide specific financial data such as revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on clinical trial progress and strategic developments.
Material Changes and Clinical Updates
As of the June 12, 2026 data cutoff, the following clinical updates were reported:
- Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC): 93% (13/14) of heavily pretreated patients receiving 900 mg QD monotherapy achieved greater than 50% reduction in the tumor marker CA19-9. Evidence of dose-dependent anti-tumor activity was observed between 600 mg and 900 mg doses. The combination with cetuximab showed deeper and more rapid tumor reductions, and the drug demonstrated combinability with standard-of-care chemotherapy (Gem/NabP).
- Metastatic Colorectal Cancer (mCRC): Preliminary efficacy signals were observed with full-dose cetuximab at both 600 mg and 900 mg dose levels. The 900 mg QD combination with cetuximab was dose-limiting toxicity (DLT)-cleared in May 2026.
- Advanced Non-Small Cell Lung Cancer (NSCLC): Preliminary efficacy was observed at 600 mg QD monotherapy. The 900 mg QD dose level is planned for the registration-directed TARGET-D 202 Phase 2 study.
- Safety Profile: VS-7375 demonstrated a favorable safety profile at 600 mg and 900 mg doses. Treatment-related adverse events were primarily low-grade nausea, vomiting, and diarrhea, which generally diminished over time. No unexpected adverse events or clinically meaningful cytopenias were reported.
Guidance, Outlook, and Strategic Developments
Strategic Collaboration: Verastem announced its intent to enter into an agreement with Erasca, Inc. to evaluate VS-7375 in combination with ERAS-0015 (an oral panRAS molecular glue) in preclinical models, with potential future clinical collaboration starting in 2027.
Expected Key Milestones:
- Complete target enrollment in TARGET-D 101 cohorts by the end of June 2026.
- Announce first patient dosed in TARGET-D 202 and TARGET-D 203 trials in mid-2026.
- Complete enrollment across all three TARGET-D Phase 2 trials by the end of 2026.
- Meet with the U.S. FDA before the end of 2026 to review Phase 3 pivotal trial designs.
- Enroll the first patient in Phase 3 pivotal trials in the first half of 2027.
Investor Verification Checklist
- Verify the execution of the definitive agreement with Erasca, Inc. and the results of the preclinical evaluation of the VS-7375 and ERAS-0015 combination.
- Monitor the upcoming data update for the TARGET-D 101 trial scheduled for the second half of 2026.
- Confirm the timeline for the first patient dosing in the registration-directed Phase 2 trials (TARGET-D 202 and 203).
- Review the FDA meeting outcomes regarding Phase 3 trial designs for mPDAC, mCRC, and NSCLC.
- Assess the long-term safety data as patient follow-up matures beyond the current six-month threshold.