Verastem announces updated data from GenFleet’s Phase 1 GFH375 study

Verastem (VSTM) Oncology announced updated data from the dose escalation phase of the Phase 1/2 trial of GFH375. As of May 16, 2025, 23 efficacy-evaluable patients with pancreatic ductal adenocarcinoma and 12 efficacy-evaluable patients with non-small cell lung cancer achieved an overall response rate of 52% and 42%, respectively. The updated data were presented by Verastem’s partner, GenFleet Therapeutics, in a rapid oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting on June 2, 2025, in Chicago, IL. GenFleet reported that 62 patients were enrolled in the Phase 1 portion of the study in China, receiving oral doses ranging from 100 to 900 mg daily. In the study, 98% of patients had metastatic disease, and 75% had received greater than or equal to2 prior lines of therapy. As of the data cutoff of May 16, 2025, 23 efficacy-evaluable patients with PDAC and 12 efficacy-evaluable patients with NSCLC, who received daily dosages of 400 or 600 mg and had at least one post-treatment tumor assessment, achieved an ORR of 52% and a disease control rate of 100%, and an ORR of 42% and a DCR of 83%, respectively. As of the cutoff date of March 31, 2025, GenFleet reported that there were no dose-limiting toxicities observed across all dose levels, and the treatment-related adverse events were mostly Grade 1/2. The most common TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia. TRAEs greater than or equal to Grade 3 consisted mainly of decreased neutrophil count and diarrhea. No TRAE-related deaths were reported.