Oral KRAS G12D Inhibitor GFH375/VS-7375 Advances in Chinese and Overseas Registrational Trials

GFH375/VS-7375, an oral KRAS G12D inhibitor, has received three breakthrough therapy designations in China for KRAS G12D-mutant pancreatic cancer, NSCLC and colorectal cancer, and has entered two registrational Phase III studies as monotherapy in pancreatic cancer and NSCLC. Partner Verastem Oncology plans first-line PDAC Phase III trials of multiple combination regimens with anti-EGFR therapy or chemotherapy by year-end, with PFS and ORR as dual primary endpoints and OS as secondary, under FDA-agreed protocols.