Merck and Moderna have announced the commencement of the INTerpath-009, a Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s Keytruda (pembrolizumab). This adjuvant treatment is intended for patients with resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (pCR) following neoadjuvant Keytruda plus platinum-based chemotherapy. The trial has begun global recruitment, with the first patients now enrolling in Canada.
Addressing Unmet Needs in Early-Stage NSCLC
Lung cancer remains the leading cause of cancer-related deaths worldwide, despite improvements in overall survival rates in recent years. The INTerpath-009 trial aims to address the unmet need for more effective treatments in earlier stages of NSCLC. "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," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
Trial Design and Objectives
The INTerpath-009 trial is designed to assess the efficacy and safety of V940 in combination with Keytruda as adjuvant therapy. Patients eligible for the trial include those with resectable Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pCR after neoadjuvant treatment with Keytruda and platinum-based chemotherapy. The primary endpoint of the trial is to determine the impact of the combination therapy on recurrence-free survival. Secondary endpoints include overall survival and safety assessments.
Leveraging mRNA Technology
Moderna's mRNA technology is at the forefront of this research effort. "We believe that our mRNA technology has the potential to improve the outcomes of those affected by lung cancer, and 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. The trial represents a significant step forward in exploring the potential of individualized neoantigen therapies to enhance treatment outcomes in NSCLC.
