GenFleet Therapeutics, a commercial-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced that the latest phase I/II study results for GFH375 were accepted as a late-breaking abstract (LBA) for the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer. The conference will take place in Barcelona, Spain from Sept. 6-9, with a mini oral presentation scheduled for Sept. 7 to highlight the efficacy and safety data of GFH375 in patients with advanced non-small cell lung cancer (NSCLC).
Following IND approval for a phase I/II study in China in June 2024, a total of 142 patients have been enrolled, including 28 NSCLC and 85 pancreatic ductal adenocarcinoma (PDAC) patients. As of July 15, 2025, the median follow-up time for the 28 NSCLC patients (100% adenocarcinoma) was 4.5 months. Tumor responses were observed across all dose levels: among 26 evaluable patients, the objective response rate (ORR) was 57.7% and the disease control rate (DCR) was 88.5%; a higher response rate was observed in the 600 mg QD (RP2D) cohort, with an ORR of 68.8% and a DCR of 93.8%.
Mini oral presentation of GFH375X1101 study
LBA title: Efficacy and safety of GFH375 in advanced non-small cell lung cancer patients with KRAS G12D mutation
Session: New Treatment Strategies in Other Than EGFR-Positive Tumors
Presenter: Professor Ziming Li (Shanghai Chest Hospital)
Session Date and Time: 12 pm-1:15 pm, Sept. 7 (Local time)
Based on clinical data to date, the trial demonstrated that GFH375 was well-tolerated with a manageable safety profile, with no new safety signals observed. As of June 17, the most frequent treatment-related adverse events (TRAEs) that occurred in at least 20% of 142 patients included diarrhea, vomiting, nausea and anemia, primarily graded 1 or 2. Grade 3/4 TRAEs and serious adverse events (SAEs) were reported in 27.5% and 7.7% of patients respectively, with no treatment-related deaths. Detailed data will be presented at the upcoming annual meeting.
"Earlier this year, the preliminary data from GFH375 study for advanced solid tumors were selected for a rapid oral presentation at the ASCO annual meeting. Now, we are pleased to announce that preliminary data from NSCLC treatment of the study will be featured in an LBA at WCLC. In early September, we will present detailed data of this oral KRAS G12D inhibitor with promising therapeutic potential. Upon encouraging efficacy, pivotal studies of GFH375 treating PDAC and NSCLC will be initiated in China, accelerating clinical development and delivering this life-saving therapy to patients worldwide". stated Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.
