Merck and Moderna have announced the start of INTerpath-009, a Phase 3 randomized clinical trial evaluating V940, an individualized neoantigen therapy, in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). The study targets patients who did not achieve a pathological complete response after neoadjuvant treatment with Keytruda plus platinum-based chemotherapy.
Trial Design and Patient Population
INTerpath-009 is designed as a pivotal Phase 3 trial. It aims to evaluate the efficacy and safety of the V940/Keytruda combination in improving outcomes for NSCLC patients who have undergone surgery but still have residual disease. The trial is enrolling patients globally, with the first patients already receiving treatment in Canada. The inclusion criteria focus on individuals with Stage II, IIIA, or IIIB NSCLC who have not achieved a complete pathological response following neoadjuvant Keytruda and platinum-based chemotherapy.
Investigational Therapy: V940
V940 is an investigational individualized neoantigen therapy. Neoantigen therapies are designed to target the unique mutations present in an individual patient's tumor, potentially offering a more personalized approach to cancer treatment. By combining V940 with Keytruda, researchers aim to leverage the synergistic effects of personalized immunotherapy and checkpoint inhibition to enhance the body's immune response against cancer cells.
Clinical Significance
Lung cancer remains a leading cause of cancer-related deaths worldwide, with NSCLC accounting for the majority of cases. Adjuvant therapy plays a crucial role in preventing recurrence and improving survival rates in patients who have undergone surgical resection. The combination of V940 and Keytruda represents a novel approach to adjuvant treatment, potentially addressing the unmet needs of patients who do not achieve a complete response with standard neoadjuvant chemotherapy and immunotherapy.
