GenFleet's Oral KRAS G12D Inhibitor GFH375 Posts Strong Phase II Results in Pretreated NSCLC, Paving Way for First Global Phase III
核心洞察
GenFleet Therapeutics (搜索) reported updated Phase II results for its oral KRAS G12D (搜索) inhibitor GFH375 in pretreated non-small cell lung cancer (搜索), presented at the 2026 World Conference on Lung Cancer.
At 600 mg once daily, GFH375 achieved objective response and disease control rates above 50% and 90%, with median progression-free survival approaching or exceeding eight months.
The 12-month overall survival rate reached 77% across all patients, though higher-grade toxicities were observed in patients recently exposed to immune checkpoint inhibitors.
GenFleet Therapeutics (搜索) (Shanghai), Inc. has reported updated Phase II results for its oral KRAS G12D (搜索) inhibitor GFH375 in pretreated non-small cell lung cancer (搜索) (NSCLC), demonstrating strong efficacy in a heavily metastatic patient population with manageable safety at a 600 mg once-daily dose. The data were presented at the 2026 World Conference on Lung Cancer and underpin the drug's Breakthrough Therapy Designation in China.
Efficacy and Safety at 600 mg Once Daily
The Phase II study showed objective response and disease control rates above 50% and 90%, respectively. Median progression-free survival approached or exceeded eight months, and the 12-month overall survival rate was 77% among all patients.
Safety was described as manageable at the 600 mg once-daily dose. Investigators identified higher-grade toxicities in patients who had been recently exposed to immune checkpoint inhibitors, a finding that may inform patient selection and monitoring in subsequent development.
Regulatory Designation and Phase III Advancement
The updated results support GFH375's Breakthrough Therapy Designation in China and support progression into what GenFleet describes as the world's first Phase III study of an oral KRAS G12D (搜索) inhibitor in NSCLC. The company said the data strengthen its competitive position in targeted lung cancer treatments and validate its RAS-focused strategy.
Partnership and Commercialization Rights
The results also enhance the value of GenFleet's global development partnership with Verastem, which holds commercialization rights for GFH375 outside China. GenFleet Therapeutics (搜索) (Shanghai), Inc. trades as Class H shares under the ticker HK:2595.