Verastem Oncology Initiates Phase 2 Registration-Directed Trial of VS-6766 and Defactinib in Previously Treated KRAS Mutant Non-Small Cell Lung Cancer

Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced the initiation of a Phase 2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, alone and in combination with defactinib, its FAK inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC).

“Currently available options for patients with KRAS mutant NSCLC are associated with minimal efficacy, as well as resistance and toxicity issues. Our study will further elucidate the impact of VS-6766, alone or in combination with defactinib, in overcoming these challenges to improve outcomes,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “Our VS-6766 and defactinib NSCLC development program’s specific focus on G12V mutations is unique and represents a potentially significant step forward in understanding how we can deliver a better treatment option for these patients.”

The RAMP 202 (Raf And Mek Program) study is a Phase 2, adaptive two-part multicenter, parallel cohort, randomized, open-label trial to evaluate the efficacy and safety of VS-6766 alone and in combination with defactinib in patients with KRAS mutant NSCLC, following treatment with a platinum-based regimen and immune checkpoint inhibitor.¹ The first part of the study will determine the optimal regimen of either VS-6766 monotherapy or in combination with defactinib in patients with KRAS-G12V mutant NSCLC randomized 1:1 in each treatment arm. An exploratory arm of the initial phase of the study will evaluate other KRAS mutations. The determination of which regimen to take forward into the expansion phase of the trial will be made based on data from KRAS-G12V mutant patients. The second phase of the study will examine efficacy and safety parameters of the most effective regimen. Additional information about this study can be found here on ClinicalTrials.gov (NCT04620330).

“In this study, we hope to advance our understanding of a potential new option for patients with KRAS mutant NSCLC by targeting the RAF/MEK and FAK pathways,” said D. Ross Camidge, M.D., Ph.D., Director of Thoracic Oncology at the University of Colorado School of Medicine and University of Colorado Cancer Center member and the study’s U.S. principal investigator. “Some key advances have come from looking at specific KRAS mutations and by also focusing on G12V mutations, allowing us to build upon the areas that have shown particular promise and determine an optimal path forward.”