Verastem Oncology and Amgen Partner to Evaluate VS-6766 in Combination with LUMAKRASTM (Sotorasib) in Patients with KRAS G12C-Mutant Non-Small Cell Lung Cancer

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced a clinical collaboration agreement with Amgen to evaluate the combination of VS-6766, Verastem Oncology’s investigational dual RAF/MEK inhibitor, with Amgen’s KRAS G12C inhibitor LUMAKRAS^TM (sotorasib) in KRAS G12C-mutant non-small cell lung cancer (NSCLC).

The Phase 1/2 trial will evaluate the safety, tolerability and efficacy of VS-6766 in combination with LUMAKRAS^TM in patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor as well as in patients who have progressed on a KRAS G12C inhibitor. 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^TM (G12C inhibition) in KRAS G12C-mutant locally advanced or metastatic NSCLC.

“Recent data indicate that acquired resistance to KRAS G12C inhibitors in patients occurs predominantly through additional mutations in the RAS pathway, many of which may be addressed with a downstream inhibitor such as VS-6766,”¹ said Ramaswamy Govindan, M.D., Professor, Department of Medicine, Oncology Division at Washington University School of Medicine and lead investigator of the study. “This clinical study of VS-6766 and LUMAKRAS^TM will build on preclinical data showing synergy between these two agents, including tumor regression through deeper blockade of ERK pathway signaling.”²

“We are pleased to partner with Amgen on this important research that could potentially expand treatment options for patients with KRAS G12C-mutant NSCLC,” said Brian Stuglik, CEO of Verastem Oncology. “This collaboration advances our strategy to fully explore the potential of VS-6766 as a backbone of therapy to treat RAS pathway-driven cancers.”

Verastem Oncology expects to initiate the clinical trial with VS-6766 and LUMAKRAS^TM by the end of 2021.

About KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

Approximately 85% of lung cancers are non-small cell lung cancer (NSCLC), which are the single leading cause of cancer deaths worldwide.³ KRAS mutation occurs in approximately 25% of NSCLC adenocarcinoma patients.⁴ Two of the most common types of KRAS mutations are G12C, which occurs in approximately 13% of patients with NSCLC adenocarcinoma, as well as G12V, which is present in approximately 7% of NSCLC.^5,6 Currently, there is a high unmet need in the second-line treatment of KRAS mutant NSCLC.3^,7