Verastem, Inc. 8-K

What Happened

• On June 23, 2026 Verastem, Inc. posted an investor presentation and announced preliminary data from the ongoing TARGET‑D 101 Phase 1/2 trial of VS‑7375 (oral KRAS G12D On/Off inhibitor). The presentation was used in an investor call/webcast scheduled for June 23, 2026 at 4:30 p.m. ET.
• Verastem also announced its intent to enter an agreement with Erasca, Inc. to evaluate VS‑7375 combined with Erasca’s investigational panRAS molecular glue ERAS‑0015 in preclinical KRAS G12D models, with the companies saying they may pursue a clinical collaboration depending on results and a definitive agreement.

Key Details

• Data cutoff: June 12, 2026. Dose‑escalation is ongoing up to 1,200 mg QD; PK data show 900 mg QD achieves target plasma levels and is clearly separated from 600 mg QD.
• Efficacy signals across tumor types (monotherapy and combos): responses seen at 400, 600 and 900 mg QD in mPDAC, mCRC and advanced NSCLC cohorts.
• Notable mPDAC result: at 900 mg QD monotherapy, 93% (13/14) of heavily pretreated evaluable patients had >50% reduction in tumor marker CA19‑9; follow‑up is maturing.
• Safety: favorable tolerability at 600 mg QD (n=57) and 900 mg QD (n=25); TRAEs mainly low‑grade nausea, vomiting and diarrhea that generally decreased after cycle 1; no unexpected AEs or meaningful cytopenias/liver abnormalities reported.
• Combination milestones: 600 mg QD + Gem/NabP was DLT‑cleared; 900 mg QD + full‑dose cetuximab was DLT‑cleared in May 2026 and will be used in the TARGET‑D 203 registration‑directed mCRC trial.
• Near‑term plans: update TARGET‑D 101 in 2H 2026; complete TARGET‑D Phase 2 enrollments and begin Phase 3 patient enrollment in H1 2027 (company provided these as forward‑looking targets).

Why It Matters

• For investors, the filing highlights early clinical activity for VS‑7375 across multiple KRAS G12D tumor types and a tolerable safety profile at planned Phase 2 dose levels—key factors for advancing toward registration‑directed studies. The ability to combine VS‑7375 with standard chemotherapy and with cetuximab without overlapping toxicities supports broader development options.
• The intended preclinical collaboration with Erasca could expand combination strategies against RAS‑driven tumors if preclinical results are positive and a definitive agreement is executed.
• These results are preliminary, from small cohorts with limited follow‑up, and the company’s timeline and plans are forward‑looking and subject to risks and uncertainties described in the filing.