GenFleet Therapeutics (Shanghai) Inc. (GenFleet, 2595) reported that its oral KRAS G12D (ON/OFF) inhibitor GFH375 received Breakthrough Therapy Designation from the Center for Drug Evaluation of the National Medical Products Administration. This designation applies to KRAS G12D-mutant non-small cell lung cancer in patients who have received at least one prior systemic therapy.

According to phase I/II data from the GFH375X1101 study, GFH375 as a monotherapy has demonstrated encouraging efficacy and a manageable safety profile in the global KRAS G12D inhibitor landscape. Results from this study have been presented at major academic conferences, including the American Society of Clinical Oncology Annual Meeting and the World Conference on Lung Cancer, with further data releases anticipated later in the year.

GenFleet’s research and development efforts for GFH375 include its advancement into the world’s first phase III trial of an oral KRAS G12D inhibitor in metastatic pancreatic cancer. GFH375 has also been granted Fast Track Designation by the U.S. FDA for metastatic KRAS G12D-mutated pancreatic ductal adenocarcinoma, and multiple combination and monotherapy trials are underway in various tumor types.

GFH375 stems from a discovery and development partnership between GenFleet and Verastem Oncology. GenFleet holds rights to GFH375 within China, while Verastem Oncology holds rights outside China. The latest announcement highlights the significant potential of GFH375 for treating KRAS G12D-driven cancers and indicates plans for continued data updates at global academic events later this year.