Merck (NYSE: MRK), also known as MSD outside the U.S. and Canada, and Moderna, Inc. (Nasdaq: MRNA), announced the launch of INTerpath-009, a Phase 3 randomized clinical trial investigating V940 (mRNA-4157), an individualized neoantigen therapy (INT), combined with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. This combination is being evaluated as an adjuvant treatment for patients with resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) who did not achieve a pathological complete response (pCR) after receiving neoadjuvant KEYTRUDA with platinum-based chemotherapy. Enrollment for INTerpath-009 has begun globally, with the first patients in Canada now participating.
“Survival rates for non-small cell lung cancer have improved, but lung cancer remains the leading cause of cancer deaths worldwide,” said Dr. Marjorie Green, Merck’s senior vice president and head of oncology, global clinical development. “Our expanded partnership with Moderna to study V940 (mRNA-4157) with KEYTRUDA aims to advance meaningful new options for lung cancer patients, especially in earlier disease stages where the potential impact is greatest.”
Dr. Kyle Holen, Moderna’s senior vice president and head of Therapeutics and Oncology development, added, “We’re excited to broaden our work with Merck to explore how our mRNA technology may improve outcomes for NSCLC patients. Together, INTerpath-002 and INTerpath-009 trials are designed to highlight the potential of this approach in early-stage lung cancer, both with and without prior neoadjuvant therapy.”
Current Clinical Development Programs
Merck and Moderna have expanded their Phase 3 trials, evaluating V940 (mRNA-4157) in combination with KEYTRUDA as an adjuvant treatment for patients with high-risk, resected Stage IIB-IV melanoma (INTerpath-001, NCT05933577) and non-small cell lung cancer (INTerpath-002, NCT06077760).
In 2024, they also initiated a two-part Phase 2/3 trial for mRNA-4157 (V940) combined with KEYTRUDA as neoadjuvant and adjuvant treatment in resectable, locally advanced Stage II-IV (M0) cutaneous squamous cell carcinoma (INTerpath-007, NCT06295809), a Phase 2 trial as an adjuvant for intermediate-high-risk renal cell carcinoma (INTerpath-004, NCT06307431), and a Phase 2 trial for high-risk, muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005, NCT06305767).
