Verastem Oncology (NASDAQ:VSTM) saw its shares gain about 4% in after-hours trading Wednesday after the U.S. Food and Drug Administration granted Fast Track Designation to VS-7375 for a defined population of non-small cell lung cancer patients.
The FDA's Fast Track covers adult patients with KRAS G12D-mutated, unresectable locally advanced or metastatic non-small cell lung cancer who have previously received both platinum-based chemotherapy and an anti-PD-(L)1 antibody, administered either concurrently or sequentially.
This new designation follows an earlier Fast Track granted to VS-7375 for KRAS G12D-mutated advanced or metastatic pancreatic cancer in July 2025.
About VS-7375 and the clinical program
VS-7375 is an oral investigational inhibitor selective for the KRAS G12D mutation. The molecule is reported to bind KRAS G12D in both its active and inactive conformations. Verastem launched the Phase 1/2 TARGET-D 101 trial in June 2025. According to the company, early clinical updates from that study are expected in the first half of 2026, with more mature results due in the second half of 2026.
The company has also started TARGET-D 202, described as a Phase 2 registration-directed, open-label trial. That study is evaluating a 900 mg once-daily oral dose of VS-7375 in patients with advanced non-small cell lung cancer who have received one to two prior lines of therapy.
Safety and early tolerability data
Data disclosed from the TARGET-D 101 study in March 2026 covered 23 patients dosed at 400 mg, 600 mg and 900 mg once daily. The report indicated VS-7375 was generally well tolerated across those dose levels. As of the January 30, 2026 data cutoff, no drug-related abnormalities in liver function tests were reported and no Grade >2 neutropenia had been observed.
Patient population and unmet need
Non-small cell lung cancer represents roughly 80% to 85% of lung cancer cases. The KRAS G12D mutation is present in about 5% of non-small cell lung cancer cases, representing more than 8,000 patients in the United States each year. There are currently no FDA-approved therapies that specifically target KRAS G12D mutations in cancer.
Implications for markets
The Fast Track designation is an incremental regulatory milestone for Verastem and signals an expedited development pathway for VS-7375 in a molecularly defined subset of lung cancer. Investors will be watching the planned early and later data readouts from TARGET-D 101 as the next clinical catalysts.