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Soo Park, MD
Soo Park, MD
Posted: Friday, June 13, 2025
The phase III RELATIVITY-098 trial sought to address the currently unmet need for effective adjuvant regimens for completely resected melanoma. Results from the trial—which evaluated adjuvant therapy with the PD-1 inhibitor nivolumab plus the LAG-3 inhibitor relatlimab-rmbw vs nivolumab alone for resected stage III–IV melanoma—were presented at the 2025 ASCO Annual Meeting by Georgina V. Long, MD, PhD, of the Melanoma Institute Australia and the University of Sydney, and colleagues.
The randomized, double-blind study enrolled 1,093 patients with stage III or higher melanoma. They were randomized to receive either nivolumab plus relatlimab or nivolumab alone every 4 weeks for a maximum of 1 year, or until first recurrence or unacceptable toxicity. Patient characteristics were balanced between arms, including disease stage and nonacral vs acral melanoma. The median duration of therapy was 11.0 months in both groups. The primary endpoint of the study was recurrence-free survival; secondary endpoints included overall survival, distant metastasis–free survival, and safety.
At minimum follow-up of 23.4 months, researchers found no statistical differences between arms, with recurrence-free survival being consistent across stratification factors and prespecified subgroups. Distant metastasis–free survival was also similar in in both treatment groups—73.1% with the combination and 76.3% with nivolumab alone. One hundred and forty-eight overall survival events occurred, and grade 3/4 treatment-related adverse events occurred in 19% of patients treated with nivolumab and relatlimab compared to 8% of those treated with nivolumab alone. This led to a discontinuation of treatment in 17% vs 9% of patients, respectively, and three treatment-related deaths (two in the nivolumab and relatlimab arm and one in nivolumab alone arm).
While the safety profile of nivolumab plus relatlimab was consistent with results from RELATIVITY-047, the study authors concluded that nivolumab plus relatlimab did not result in a significant improvement over nivolumab alone. An analysis of biomarkers for this study is currently underway, and results will be published in the future.
Disclosures: For full disclosures of study authors visit asco.org.
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