Merck and Moderna have announced the initiation of the INTerpath-009, a pivotal Phase 3 trial evaluating V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as adjuvant treatment for resectable Stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) patients who did not achieve a pathological complete response (pCR) after receiving neoadjuvant Keytruda plus platinum-based chemotherapy.
Trial Details and Patient Population
The global Phase 3 trial, INTerpath-009, has begun enrolling patients in Canada. The study focuses on NSCLC patients with specific characteristics: resectable Stage II, IIIA, or IIIB (N2) disease who have not achieved a pathological complete response (pCR) following neoadjuvant treatment with Keytruda and platinum-based chemotherapy. This patient population represents a critical unmet need, as they face a higher risk of recurrence despite initial treatment.
V940: An Individualized Neoantigen Therapy
V940 (mRNA-4157) is an investigational individualized neoantigen therapy. It is designed to target the unique mutations present in a patient's tumor. When combined with Keytruda, an anti-PD-1 therapy, the combination aims to stimulate a more robust and personalized immune response against cancer cells.
Prior Clinical Data
In June, Merck and Moderna presented results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study. With a median follow-up of approximately three years (34.9 months), adjuvant treatment with mRNA-4157 (V940) in combination with Keytruda continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival (RFS), the primary endpoint of the study, reducing the risk of recurrence or death by 49% compared with Keytruda alone in melanoma patients.
Expanding Clinical Program
Merck and Moderna have initiated multiple Phase 3 trials evaluating mRNA-4157 (V940) in combination with Keytruda as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma (INTerpath-001) and non-small cell lung cancer (INTerpath-002). In 2024, Merck and Moderna also initiated a two-part Phase 2/3 trial evaluating mRNA-4157 in combination with Keytruda as neoadjuvant and adjuvant treatment for resectable locally advanced Stage II-IV cutaneous squamous cell carcinoma (INTerpath-007), a Phase 2 trial of mRNA-4157 (V940) plus Keytruda as adjuvant treatment for intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004), and a Phase 2 trial of mRNA-4157 plus Keytruda as adjuvant treatment for high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005).
