The Phase 3 INTerpath-009 trial has commenced recruitment to investigate the potential of mRNA-4157 in conjunction with pembrolizumab for the treatment of advanced non-small cell lung cancer (NSCLC). This study, sponsored by Merck and Moderna, seeks to evaluate the efficacy and safety of combining an mRNA-based therapeutic with an immune checkpoint inhibitor in patients with previously untreated advanced NSCLC.
Trial Design and Objectives
The INTerpath-009 trial is designed as a randomized, open-label, Phase 3 study. It aims to enroll patients with histologically or cytologically confirmed Stage IV or recurrent NSCLC who have not received prior systemic therapy for advanced disease. The primary objective is to assess the progression-free survival (PFS) and overall survival (OS) of patients treated with the combination of mRNA-4157 and pembrolizumab compared to standard chemotherapy.
Secondary endpoints include objective response rate (ORR), duration of response (DoR), and safety profile. The trial will also explore biomarkers to identify patients most likely to benefit from the combination therapy.
mRNA-4157 and Pembrolizumab
mRNA-4157 is an investigational individualized neoantigen therapy (iNeST) designed to stimulate the patient's immune system to recognize and attack cancer cells based on the unique mutations present in their tumors. Pembrolizumab is an anti-PD-1 antibody, an immune checkpoint inhibitor that enhances the body's natural ability to fight cancer.
The combination of mRNA-4157 and pembrolizumab represents a novel approach to cancer treatment, potentially offering a more personalized and effective strategy compared to traditional therapies. The trial will provide critical data on the clinical benefit and safety of this combination in NSCLC.
Significance for NSCLC Treatment
NSCLC accounts for a significant proportion of lung cancer cases globally. Despite advances in treatment, the prognosis for patients with advanced NSCLC remains poor, highlighting the need for innovative therapeutic strategies. The INTerpath-009 trial addresses this unmet medical need by exploring the potential of mRNA-based therapy in combination with immune checkpoint inhibition to improve outcomes for patients with advanced NSCLC.
