Merck and Moderna Initiate Phase 3 Trial of V940/Keytruda Combo in NSCLC
Key Insights
Merck (search) and Moderna have commenced the INTerpath-009 Phase 3 trial to evaluate V940 (mRNA-4157) combined with Keytruda for non-small cell lung cancer (search) (NSCLC (search)).
The trial targets patients with resectable Stage II, IIIA, or IIIB (N2) NSCLC (search) who did not achieve a pathological complete response (pCR) after neoadjuvant treatment.
V940, an individualized neoantigen therapy, is being developed alongside Keytruda (pembrolizumab) as an adjuvant treatment.
Merck (search) 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 (search) (NSCLC (search)) 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 (search) 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 (search) 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 (search) patients.
Expanding Clinical Program
Merck (search) 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 (search) (INTerpath-001) and non-small cell lung cancer (search) (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).