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%.
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” .
About GFH375/VS-7375
GFH375 is an orally active, potent, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor designed to target the GTP/GDP exchange, thereby disrupting the activation of downstream pathways and effectively inhibiting tumor cell proliferation. Preclinical studies demonstrated dose-dependent inhibition in models bearing KRAS G12D mutation; GFH375 also demonstrated low off-target risk in kinase selectivity and safety target assays.
GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) to advance three novel oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase I trial. Verastem selected GFH375/VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, as its lead program from the collaboration, in December 2023 and the license for GFH375 that was exercised in January 2025 is the first one from this collaboration. The licenses would give Verastem development and commercialization rights outside of China while GenFleet would retain rights inside of China.
About GenFleet Therapeutics
GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies, is dedicated to serving significant global unmet medical needs in oncology and immunology. Based on the deep understanding of disease biology and translational medicine, GenFleet’s proprietary and fully integrated R&D platform highlights multiple cutting-edge products with novel mechanisms and global IP.
Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 10 programs, many of which have entered multi-regional clinical trials across China (including Taiwan), the United States, Europe and Australia. To date, GenFleet has over 5 clinical studies encompassing IND stage to phase II studies and completed co-development partnerships with numerous publicly listed companies worldwide.
GenFleet is expected to progress additional programs into the clinic, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.
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Tel.: 021-68821388
Mail: pr@genfleet.com; bd@genfleet.com
Website: www.genfleet.com
Add.: 1206 Zhangjiang Road, Building A, Shanghai
