NEW YORK – Boston-based Verastem Oncology on Monday said it had inked a deal to study its RAF/MEK inhibitor VS-6766 with Amgen's KRAS G12C inhibitor sotorasib (Lumakras) in KRAS G12C-mutant non-small cell lung cancer.
Researchers in the Phase I/II trial will track the combination regimen's safety, tolerability, and efficacy in NSCLC patients with KRAS G12C-mutant tumors who have never received a therapy targeting these mutations and those who have progressed on such treatments.
Preclinical research has shown that patients become resistant to KRAS G12C inhibitors through mutations in the RAS pathway. "The study will therefore investigate the potential benefits of a more complete vertical blockade of the RAS pathway with the combination of VS-6766 (RAF/MEK blockade) with Lumakras (G12C inhibition) in KRAS G12C-mutant locally advanced or metastatic NSCLC," the company said in a statement.
Verastem will begin its combination trial of VS-6766 and sotorasib by the end of 2021. The company has also started registration enabling Phase II trials of VS-6766 with its investigational FAK inhibitor defactinib in recurrent low-grade serous ovarian cancer patients and NSCLC patients with KRAS G12V mutations.
Earlier this year, the FDA approved Amgen's sotorasib for previously treated, locally advanced, or metastatic NSCLC patients whose tumors harbor a KRAS G12C mutation, making it the first KRAS inhibitor to enter the market.