Verastem’s VS-7375 shows efficacy in lung cancer

Verastem (VSTM) announced positive, updated safety and efficacy data and late-breaking presentation details of partner GenFleet Therapeutics’ Phase 1/2 study in China of GFH375, an oral KRAS G12D inhibitor, known as VS-7375 outside of China, in advanced non-small cell lung cancer patients with a KRAS G12D mutation. The data will be presented in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer September 6-9, in Barcelona. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. In April, the IND application for VS-7375 was cleared and Verastem initiated a Phase 1/2a clinical trial in June. GenFleet’s IND for VS-7375 was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024. The late-breaking abstract was issued today by the WCLC. GenFleet reported cumulative safety data across the entire study population and preliminary efficacy data specific to patients with advanced NSCLC from the Phase 1/2 study in China. Tumor response was observed across the dose range tested. At the recommended Phase 2 dose of 600 mg once daily, the ORR was 68.8% and the disease control rate was 93.8%. Across all cancer types and dose levels evaluated, the most common treatment-related adverse events occurring in at least 20% of patients were diarrhea, vomiting, nausea, anemia, decreased appetite, neutrophil count decreased, white blood cell count decreased, aspartate aminotransferase increased, asthenia, hypoalbuminemia, and alanine aminotransferase increased, predominately Grade 1 or 2 in severity. TRAEs and severe adverse events, greater than Grade 3, occurred in 27.5% and 7.7% of patients, respectively. Of the 142 patients in the safety population, 11 patients had dose reduction, and six discontinued due to TRAEs. No TRAE-related deaths were reported.