Bristol Myers Squibb's Opdualag, a combination of the company's PD-1 inhibitor Opdivo (nivolumab) and relatlimab (an anti-LAG-3 antibody), has shown promising results in a Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The RELATIVITY-104 trial investigated whether adding relatlimab to Opdivo and chemotherapy could improve outcomes as a first-line treatment for these patients. The positive signals observed have led to the initiation of a Phase 3 study to further evaluate the combination.
The study's primary objective was to determine which patients with advanced NSCLC would benefit from the addition of relatlimab to a backbone of chemotherapy and Opdivo. Samit Hirawat, Bristol Myers Squibb’s chief medical officer, highlighted the importance of identifying these specific patient populations. Opdualag is already approved for advanced melanoma, but has faced setbacks in other cancer types, including colorectal and liver cancer. The dose of Opdualag used in the lung cancer study was higher than that approved for melanoma.
Trial Design and Objectives
The Phase 2 RELATIVITY-104 trial was designed to assess the efficacy and safety of Opdualag in combination with chemotherapy compared to Opdivo and chemotherapy alone in the first-line treatment of advanced NSCLC. The trial aimed to identify potential biomarkers or patient characteristics that could predict response to the addition of relatlimab. The study's findings will help guide the design and patient selection for the subsequent Phase 3 trial.
Implications for Lung Cancer Treatment
Lung cancer remains a leading cause of cancer-related deaths worldwide, with NSCLC accounting for the majority of cases. While checkpoint inhibitors like Opdivo have revolutionized treatment, many patients do not respond or develop resistance. The addition of relatlimab, targeting the LAG-3 pathway, represents a novel approach to enhance anti-tumor immunity and potentially overcome resistance mechanisms. If the Phase 3 trial confirms these findings, Opdualag could become a valuable new option for patients with advanced NSCLC.
