Clinical TrialJun 23, 2026, 04:07 PM
Verastem VS-7375 Phase 1/2 Data Shows Anti-Tumor Activity
AI Summary
Verastem, Inc. announced positive preliminary data from its ongoing TARGET-D 101 Phase 1/2 clinical trial for VS-7375, an investigational KRAS G12D inhibitor. The data showed anti-tumor activity and a favorable safety profile across advanced KRAS G12D-mutated solid tumors, including pancreatic, colorectal, and non-small cell lung cancers. Additionally, Verastem intends to collaborate with Erasca, Inc. to evaluate VS-7375 in combination with ERAS-0015. The company is progressing towards broad registrational development, with plans to initiate three Phase 3 trials by the first half of 2027.
Key Highlights
- VS-7375 showed anti-tumor activity at 400 mg, 600 mg, and 900 mg QD in mPDAC, mCRC, and NSCLC.
- 93% (13/14) of mPDAC patients at 900 mg QD monotherapy achieved over 50% reduction in tumor marker CA19-9.
- Preliminary data suggest combination with cetuximab leads to deeper and more rapid tumor reductions.
- VS-7375 600 mg QD in combination with full-dose Gem/NabP was dose limiting toxicity-cleared in mPDAC.
- VS-7375 900 mg QD in combination with full dose cetuximab was DLT-cleared in mCRC.
- VS-7375 demonstrated a favorable safety profile with primarily low-grade gastrointestinal adverse events.
- Verastem announced intent to partner with Erasca, Inc. to evaluate VS-7375 and ERAS-0015 combination.
- Company expects to initiate three Phase 3 pivotal trials by the first half of 2027.
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