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A new targeted therapy, VS-7375, is turning heads in pancreatic cancer treatment. In a phase 1/2 trial, the drug achieved a 41% overall response rate — including two complete responses — in patients with KRAS G12D–mutated metastatic pancreatic cancer who had already received prior treatment. The FDA has granted it fast track designation, and a phase 3 trial is on the horizon.
A new targeted therapy called VS-7375 is showing real promise against one of the deadliest cancers around. In the phase 1/2 TARGET-D 101 trial, patients with KRAS G12D–mutated metastatic pancreatic ductal adenocarcinoma (mPDAC) who received VS-7375 at 900 mg daily in the second-line or later setting achieved a confirmed overall response rate (ORR) of 41% — a notable result in a disease where options are extremely limited. Two patients achieved complete responses, and the drug's safety profile was largely manageable, with most side effects being low-grade GI symptoms.
The results are significant because KRAS G12D mutations are among the most common — and historically undruggable — drivers of pancreatic cancer. VS-7375 appears to be changing that narrative, with the FDA already granting it fast track designation. Verastem Oncology has also aligned with the FDA on a phase 3 trial design (TARGET-D 301) set to open by end of 2026.
By the Numbers:
Why it matters: Pancreatic cancer has one of the lowest survival rates of any cancer, and effective second-line therapies are scarce. VS-7375 could represent the first targeted option for patients with KRAS G12D mutations — a major unmet need — potentially reshaping how this disease is treated.