Verastem announces encouraging data from ongoing phase 1/2a of VS-7375 dose

Verastem (VSTM) “announced encouraging preliminary data from the first two dose levels in its ongoing Phase 1/2a clinical trial evaluating VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, in patients with previously-treated advanced KRAS G12D mutant solid tumors. In addition, while monotherapy dose escalation continues, the Company announced it has initiated patient enrollment for the first dose escalation combination cohort evaluating VS-7375 with cetuximab. VS-7375-101 is a Phase 1/2a study being conducted in the U.S., with plans underway to expand globally, and is evaluating the safety and efficacy of VS-7375 in patients with previously-treated advanced KRAS G12D mutant solid tumors, including advanced pancreatic ductal adenocarcinoma (PDAC), both as monotherapy and in combination with other standard of care treatments. In the study, VS-7375 cleared both the 400 mg daily and 600 mg QD monotherapy doses with no dose-limiting toxicities observed. In addition, no new safety signals have been observed relative to earlier data presentations in both PDAC and non-small cell lung cancer by our partner, GenFleet Therapeutics, in its ongoing Phase 1 /2 clinical study in China evaluating VS-7375. Specifically, at the two dose levels evaluated in the U.S. cohorts, no nausea, vomiting, or diarrhea greater than Grade 1 were reported. Monotherapy dose escalation in the VS-7375-101 study started at the efficacious doses identified in GenFleet’s study, 400 mg QD and 600 mg QD. GenFleet chose 600 mg QD as their recommended Phase 2 dose in China.”