VSTM Clinical trials

Verastem Oncology Announces Late-Breaking Abstract from Partner GenFleet Therapeutics’ Study in China of GFH375 (VS-7375) in Advanced Non-Small Cell Lung Cancer at IASLC 2025 World Conference on Lung Cancer

Published August 13, 2025 at 08:29 PM

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK-pathway-driven cancers, today 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 (ON/OFF) inhibitor, known as VS-7375 outside of China, in advanced non-small cell lung cancer patients with a KRAS G12D mutation. The data

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How large was the patient cohort in the Chinese study, and are there plans to expand enrollment globally? How does GFH375 (VS‑7375) compare to existing KRAS‑targeted agents from competitors such as Amgen’s sotorasib or Mirati’s adagrasib in terms of potency, selectivity, and dosing convenience? Are there any upcoming data readouts, additional trial cohorts, or combination therapy studies that could further de‑risk the commercial potential of GFH375? What is the projected market size for KRAS G12D‑mutated NSCLC and how might this affect Verastim's revenue forecasts? What are the expected timelines for regulatory approval of GFH375 (VS-7375) in China and globally? How does the updated safety and efficacy data compare to existing KRAS G12D inhibitors in development? Will the positive Phase 1/2 data trigger any milestone payments or additional funding from GenFleet Therapeutics to Verastim? How might this data release impact Verastim's enrollment and partnership negotiations for future trials? What are the key efficacy endpoints reported in the Phase 1/2 study and how do they compare to historical benchmarks for KRAS G12D NSCLC therapies? What safety signals or adverse event profiles were observed, and could they affect the drug’s regulatory pathway or market acceptance? What is the anticipated timeline for filing a New Drug Application (NDA) or seeking regulatory approval in China and other major markets? How will the partnership with GenFleet Therapeutics impact revenue sharing, commercialization rights, and cost structure for Verastim Oncology? What is the projected market size for a KRAS G12D‑targeted oral inhibitor in advanced NSCLC, both in China and worldwide? Will the positive data trigger any changes in the company’s guidance or financial forecasts? What are the potential pricing strategies for GFH375 in China, and how might they differ from pricing in other regions?