Merck and Moderna Begin Key Phase 3 Trial For Patients With NSCLC

Merck, known as MSD outside the U.S. and Canada, and Moderna, Inc. have announced the launch of INTerpath-009, a pivotal Phase 3 clinical trial. This study will evaluate V940 (mRNA-4157), an investigational personalized neoantigen therapy, combined with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as an adjuvant treatment. 

It focuses on patients with respectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) who did not reach a pathological complete response (pCR) after neoadjuvant treatment with KEYTRUDA and platinum-based chemotherapy. Recruitment for INTerpath-009 is in progress, with initial patient enrollments beginning in Canada.

Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said in a statement, “While the overall survival rates for patients with non-small cell lung cancer have significantly improved in recent years, lung cancer continues to be the leading cause of cancer death worldwide,” 

She also added, “We are pleased to expand the INTerpath clinical trial program with Moderna, evaluating V940 (mRNA-4157), a promising new modality, in combination with KEYTRUDA to pursue meaningful advances for lung cancer and bring more options to patients with earlier stages of disease, where we potentially can have the most impact.”

“We are excited to build on our ongoing collaboration with our colleagues at Merck by expanding our research efforts for patients with NSCLC. We believe that our mRNA technology can potentially improve the outcomes of those affected by lung cancer. Together, INTerpath-002 and INTerpath-009 are designed to demonstrate this potential in early-stage lung cancer, with and without prior neoadjuvant therapy,” said Kyle Holen, M.D., Moderna's senior vice president and head of development, Therapeutics and Oncology.