Dr. Tawbi on the Safety of Relatlimab Plus Nivolumab in Melanoma

Hussein A. Tawbi, MD, PhD, director, Melanoma Clinical Research and Early Drug Development and Personalized Cancer Therapy, deputy chair and professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the safety profile of relatlimab plus nivolumab (Opdualag) in patients with metastatic or unresectable melanoma, according to data from the phase 2/3 RELATIVITY-047 trial (NCT03470922).

This randomized, double-blind study evaluated the efficacy of nivolumab plus relatlimab vs nivolumab monotherapy. Updated overall survival (OS) and overall response rate (ORR) data from the trial were presented at the 2022 ASCO Annual Meeting, and previous data from the trial led to the FDA approval of relatlimab plus nivolumab in March 2022 for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.

Considering the efficacy data demonstrated a clear benefit with the combination therapy vs single-agent nivolumab, the safety results were quite impressive, Tawbi says. With a primary end point of PFS, patients in the experimental arm saw a 22% decrease in the risk of progression or death. The median PFS for patients who received the combination was more than double that of single-agent nivolumab, and the 1-year PFS for relatlimab plus nivolumab was about 48%, Tawbi explains.

Despite the improved outcomes, the efficacy benefits did not come at the expense of safety, Tawbi continues. The grade 3 toxicity rate was about 21% in the combination arm, which was similar to that of nivolumab monotherapy, Tawbi says. Moreover, all the toxicities were immune-related adverse effects, and no new safety signals were observed, Tawbi concludes.