Verastem reports VS-7375 cancer trial data

• Verastem Oncology (NASDAQ:VSTM) reported clinical data for VS-7375 showing tumor responses across pancreatic, colorectal, and lung cancer trials involving KRAS G12D mutations.
• The company reported a 41% confirmed objective response rate in second-line or later pancreatic cancer patients treated with 900 mg once-daily monotherapy.
• Verastem said it plans to begin a Phase 3 first-line metastatic pancreatic cancer trial by the end of 2026 after FDA alignment on study design.

Verastem Oncology (NASDAQ:VSTM) reported updated Phase 1/2 TARGET-D 101 trial results for VS-7375, an investigational oral KRAS G12D inhibitor, across multiple KRAS G12D-mutated solid tumors.

In metastatic pancreatic ductal adenocarcinoma, 900 mg once-daily monotherapy produced a confirmed objective response rate of 41% in the second-line or later population, with a 36% confirmed response rate in third- and fourth-line patients.

"Patients with KRAS G12D-driven cancers deserve an effective, highly targeted therapy suitable for long-term treatment," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology.

The company reported that among 22 pancreatic cancer patients treated with 900 mg once daily, two complete responses were observed, the disease control rate was 86%, and the six-month landmark progression-free survival rate was 67%.

Verastem said it reached alignment with the U.S. Food and Drug Administration on a Phase 3 trial design for first-line metastatic pancreatic cancer, with the study planned to open by year-end 2026.

Verastem Oncology develops targeted medicines for cancers driven by RAS/MAPK pathway alterations, including therapies designed for KRAS-mutated tumors.