GFH375/VS-7375 Gains Three China Breakthrough Designations and Advances Into Phase 3 Trials

The oral KRAS G12D inhibitor GFH375/VS-7375 has been granted breakthrough therapy designation by China's CDE three times, for KRAS G12D-mutant pancreatic cancer, NSCLC, and colorectal cancer, and has entered two registrational phase 3 studies as monotherapy in pancreatic cancer and NSCLC. Partner Verastem Oncology expects to start a US FDA-aligned registrational phase 3 study of VS-7375 combinations with anti-EGFR therapy or chemotherapy in first-line pancreatic ductal adenocarcinoma by year end, co-primary endpoints PFS and ORR, OS secondary.