Boston, Massachusetts-based Verastem Oncology (Nasdaq: VSTM) reported confirmed responses in four of eight patients (50%) receiving VS-7375, an oral KRAS G12D inhibitor, as second-line treatment for metastatic pancreatic ductal adenocarcinoma in the Phase I/II TARGET-D 101 trial.
Across the broader second-line-or-later population receiving 900 mg once-daily monotherapy, nine of 22 patients (41%) achieved confirmed responses. Two complete responses were observed, one confirmed and one unconfirmed. After median follow-up of 6.4 months, the disease control rate was 86%, with six-month landmark progression-free and overall survival rates of 67% and 80%, respectively. Sixteen patients remained on treatment at the October 7, 2026 cutoff.
Grade 3 treatment-related adverse events occurred in 10% of patients across 48 patients at 900 mg, the discontinuation rate due to adverse events was 2%, and no clinically meaningful cytopenias or liver function abnormalities were reported. Verastem said it reached alignment with the FDA on a Phase III first-line trial (TARGET-D 301) with dual primary endpoints of progression-free survival and objective response rate, with enrollment planned to open by year-end 2026; the Phase II TARGET-D 201 registration-directed second-line trial is currently enrolling, with initial data anticipated in Q2 2027.