Verastem VS-7375 Posts 50% ORR in Second-Line Pancreatic Cancer With FDA Phase 3 Alignment as New CEO Named

Verastem Oncology reported clinical data from its ongoing TARGET-D 101 Phase 1/2 trial of VS-7375, an oral KRAS G12D dual ON/OFF inhibitor, showing a 50% confirmed objective response rate in second-line pancreatic ductal adenocarcinoma patients receiving the 900 mg daily monotherapy dose, as of an October 7, 2026 data cutoff. In the broader second-line-plus PDAC population, VS-7375 produced a 41% confirmed ORR across 22 evaluable patients, including two complete responses, one confirmed and one unconfirmed, along with an 86% disease control rate, a 67% six-month landmark progression-free survival rate, and an 80% six-month overall survival rate, with 16 of 22 patients still on treatment.

The 900 mg dose outperformed the 600 mg level, generating deeper tumor reductions and higher response rates. In the third- and fourth-line PDAC setting, VS-7375 achieved a 36% confirmed ORR. Early results in heavily pretreated third-line-plus colorectal cancer showed a 33% unconfirmed ORR when the 900 mg dose was combined with anti-EGFR therapy, with no patients showing target lesion increases. Verastem also announced it has reached FDA alignment on a Phase 3 trial design in first-line metastatic PDAC, with plans to open the trial by year-end.

On the same day, Verastem announced that Michel Bailey will become CEO effective January 1, replacing the current leadership. Shares gapped up more than 11% in premarket trading on October 14 following the dual announcements.