FDA Clears VS-7375 First-Line Pancreatic Cancer Trial Design With ORR as Co-Primary Endpoint

The FDA has approved the design of the TARGET-D 301 trial of VS-7375/GFH375, a KRAS G12D-selective inhibitor developed by Verastem and its partner, in first-line metastatic pancreatic cancer. Overall survival is now a secondary endpoint and confirmed ORR a co-primary endpoint, with crossover allowed to accelerate approval. The decision follows a TARGET-D 101 data update on October 14 showing a confirmed ORR of 50% in second-line pancreatic cancer monotherapy and 41% across all lines.