Merck (NYSE: MRK), known as MSD in markets outside the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), have announced the launch of INTerpath-009, a pivotal Phase 3 randomized clinical trial assessing V940 (mRNA-4157), an investigational individualized neoantigen therapy, in conjunction with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. This trial aims to provide 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) following neoadjuvant treatment with KEYTRUDA plus platinum-based chemotherapy. Global recruitment for INTerpath-009 is underway, with the first patients enrolling in Canada.
“Although the survival rates for non-small cell lung cancer patients have significantly improved in recent years, lung cancer remains the leading cause of cancer-related deaths worldwide,” stated Dr. Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories. “We are excited to expand our INTerpath clinical trial program with Moderna, evaluating V940 (mRNA-4157) in combination with KEYTRUDA to advance treatment options for lung cancer, particularly in earlier stages where we may have the greatest impact.”
“We are thrilled to enhance our collaboration with Merck to expand our research for patients with NSCLC,” added Kyle Holen, M.D., senior vice president and head of development for Therapeutics and Oncology at Moderna. “We believe our mRNA technology holds the potential to improve outcomes for lung cancer patients, and together, INTerpath-002 and INTerpath-009 are designed to showcase this potential in early-stage lung cancer, both with and without prior neoadjuvant therapy.”
Ongoing Clinical Development Programs
Merck and Moderna have also initiated Phase 3 randomized clinical trials to evaluate mRNA-4157 (V940) in combination with KEYTRUDA as an adjuvant treatment for patients with resected high-risk (Stage IIB-IV) melanoma (INTerpath-001, NCT05933577) and non-small cell lung cancer (INTerpath-002, NCT06077760).
In 2024, they will launch a two-part Phase 2/3 randomized clinical trial assessing mRNA-4157 (V940) with KEYTRUDA as neoadjuvant and adjuvant treatment for patients with resectable locally advanced Stage II-IV (M0) cutaneous squamous cell carcinoma (INTerpath-007, NCT06295809). Additionally, a Phase 2 randomized clinical trial will evaluate mRNA-4157 (V940) with KEYTRUDA as an adjuvant treatment for patients with intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004, NCT06307431), and another Phase 2 trial will focus on high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005, NCT06305767).
