GENFLEET-B: Research data on the KRAS G12D inhibitor GFH375 for the treatment of advanced pancreatic ductal adenocarcinoma will be presented in an oral report and breakthrough research abstract at the 2025 ESMO Annual Meeting

According to the Zhitong Finance APP, GENFLEET-B (02595) announced that data on the single-agent treatment of KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) patients with GFH375 will be presented at the 2025 European Society for Medical Oncology (ESMO) annual meeting in Germany on October 19 local time, as a breakthrough research abstract (LBA) and oral presentation. The oral presentation will be delivered by Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences, titled "Efficacy and Safety of GFH375 in Treating Patients with Previously Treated Advanced KRAS G12D Mutant PDAC" (Abstract No.: LBA84). The report focuses on the research data of PDAC patients in the 600 mg QD (RP2D) dose group, showing that GFH375 has outstanding efficacy and controllable safety in treating PDAC patients. As of the data cutoff date, 59 patients with advanced and later-line disease (nearly 70% being third-line or above) received the first dose of GFH375 treatment at least 4 months prior to the data cutoff and underwent at least one treatment evaluation: the objective response rate was 40.7%, the disease control rate was 96.7%, the median progression-free survival was 5.52 months, and the 4-month overall survival rate was 92.2%. The G12D mutation subtype accounts for the highest proportion of KRAS mutations (nearly 30%), and according to Frost & Sullivan's predictions, the KRAS G12D mutation will affect nearly 1.38 million new cancer cases globally by 2025. Additionally, research literature indicates that nearly 40% of pancreatic cancer patients have the KRAS G12D mutation, indicating a large population with significant unmet needs. The GFH375 monotherapy was approved by the National Medical Products Administration for entry into Phase I/II trials in June 2024, and GFH375/VS-7375 has received FDA Fast Track designation this year for use in first-line and later-line treatment of locally advanced, metastatic KRAS G12D mutant PDAC patients; previously, early data on GFH375 monotherapy for solid tumors was disclosed in the form of LBA and oral presentations at authoritative international academic conferences such as ASCO and WCLC this year. Dr. Wang Yu, Chief Medical Officer of GENFLEET, stated: "Since its clinical approval last year, the GFH375 study has demonstrated rapid clinical progress and excellent efficacy. There is a huge unmet clinical need for patients with KRAS G12D mutations, and we look forward to achieving further breakthroughs in GFH375 clinical development through key studies in later-line treatment and combination therapy studies in frontline treatment." GFH375 is an orally administered, highly active, and highly selective small molecule KRAS G12D (ON/OFF) inhibitor that binds to the KRAS G12D protein in a non-covalent manner, inhibiting its binding to downstream effector proteins, thereby disrupting the continuous activation of downstream pathways by KRAS G12D in cells, ultimately effectively inhibiting tumor cell proliferation. Preclinical studies have shown that the inhibitory effect of GFH375 monotherapy on tumor growth increases with the dosage and duration of treatment, and it has demonstrated low off-target risk in kinase selectivity and safety target testing GENFLEET has reached a licensing and early collaboration development agreement with Verastem for three products related to RAS/MAPK-driven cancers developed by GENFLEET. This collaboration grants Verastem exclusive options to obtain licenses for each of the three products after successfully achieving pre-set milestones in Phase I clinical trials. In December 2023, Verastem selected GFH375/VS-7375 (an oral KRAS G12D (ON/OFF) inhibitor) as its lead project for collaboration, with the license obtained for GFH375 being the first license resulting from this collaboration. This license will grant Verastem development and commercialization rights outside of Greater China, while GENFLEET retains those rights within China