Verastem Oncology Announces Positive Efficacy Data for Partner GenFleet Therapeutics' KRAS G12D Inhibitor VS-7375 in Advanced Non-Small Cell Lung Cancer.

Verastem Oncology has announced positive data from partner GenFleet Therapeutics' Phase 1/2 study of GFH375 (VS-7375) in advanced non-small cell lung cancer. The study found an ORR of 68.8% at the recommended Phase 2 dose and 57.7% across all dose levels. The most common treatment-related adverse events were diarrhea, vomiting, nausea, and anemia. The data will be presented at the IASLC 2025 World Conference on Lung Cancer.

Verastem Oncology (Nasdaq: VSTM) has announced encouraging data from a Phase 1/2 study of GFH375 (VS-7375) in advanced non-small cell lung cancer (NSCLC). The study, conducted by partner GenFleet Therapeutics, demonstrated an overall response rate (ORR) of 68.8% at the recommended Phase 2 dose of 600 mg QD. Across all dose levels, the ORR was 57.7% in efficacy evaluable patients with NSCLC [1].

The study, which included 142 patients, reported the most common treatment-related adverse events (TRAEs) as diarrhea, vomiting, nausea, anemia, decreased appetite, and neutropenia, predominantly Grade 1 or 2 in severity. TRAEs and severe adverse events (SAEs) occurred in 27.5% and 7.7% of patients, respectively, with no TRAE-related deaths reported [1].

The data will be presented in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer from September 6-9, in Barcelona, Spain [1].

Verastem Oncology is committed to developing new medicines for patients with RAS/MAPK-pathway-driven cancers. The company's pipeline includes novel small molecule drugs that inhibit critical signaling pathways in cancer, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition [1].

The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. Verastem selected VS-7375 as its lead program in December 2023 and obtained a license for VS-7375 in January 2025 [1].

References:
[1] https://www.stocktitan.net/news/VSTM/verastem-oncology-announces-late-breaking-abstract-from-partner-gen-pydtctr7wr13.html