- Verastem Oncology (VSTM, Financial) receives FDA clearance for Investigational New Drug application of VS-7375, an oral KRAS G12D inhibitor.
- The Phase 1/2a U.S. trial for VS-7375 is set to commence in mid-2025, focusing on advanced solid tumors.
- Initial trial data will be presented at the 2025 ASCO Annual Meeting, providing insights into safety and efficacy.
Verastem Oncology (VSTM), a leading biopharmaceutical company specializing in treatments for RAS/MAPK pathway-driven cancers, has announced the U.S. Food and Drug Administration (FDA) clearance of their Investigational New Drug (IND) application for VS-7375. This oral KRAS G12D (ON/OFF) inhibitor is set to enter a Phase 1/2a trial targeting advanced solid tumors, including pancreatic, colorectal, and non-small cell lung cancers, by mid-2025.
The upcoming U.S. trial aims to build on the promising initial safety and efficacy results demonstrated in studies conducted by GenFleet Therapeutics in China. Verastem plans to explore multiple expansion cohorts within the trial, further assessing VS-7375's effectiveness both as a standalone treatment and in combination with other therapies.
Moreover, an abstract detailing the dose escalation phase of the Phase 1/2 study by GenFleet will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2025. The data, under embargo until May 22, 2025, promises to offer a comprehensive update on VS-7375's clinical potential, showcasing initial bioavailability and significant patient responses in combatting KRAS G12D mutant solid tumors.
According to Dan Paterson, CEO of Verastem Oncology, "The dual inhibition attribute of VS-7375 potentially enhances its efficacy compared to existing KRAS G12D-selective agents, suggesting improved and durable cancer response outcomes.” Verastem’s collaboration with GenFleet supports three oncology programs, marking a significant stride in their mission to develop innovative cancer treatments.
