Adjuvant nivolumab plus relatlimab in stage III/IV melanoma

Data from the RELATIVITY-098 trial published on Nature Medicine shows that the association of nivolumab plus relatlimab as adjuvant treatment doesn’t improve recurrence-free survival in patients with resected melanoma compared to nivolumab alone.

RELATIVITY-098 is a phase 3 double-blind trial where a total 1093 patients were randomized to receive adjuvant nivolumab plus relatlimab of nivolumab alone after complete resection of stage III/IV melanoma. After a median follow-up of 26.7 months, there was no difference between groups in the primary endpoint of recurrence-free survival, therefore overall survival was not tested. Based on RELATIVITY-047, nivolumab plus relatlimab is approved for advanced melanoma; thus, translational data across the two trials were analyzed and showed a lower rate of circulating LAG-3+ T cells in the adjuvant setting of the RELATIVITY-098 trial versus advanced melanoma of RELATIVITY-047, where LAG-3+ T cells were enriched in tumor versus blood. As authors conclude, «Nivolumab plus relatlimab did not significantly improve recurrence-free survival compared to nivolumab in patients with resected stage III/IV melanoma in RELATVITY-098, despite nivolumab plus relatlimab having been proven to provide benefit in patients with advanced melanoma. Translational evidence suggests that the presence of tumor may be required for the benefit of nivolumab plus relatlimab compared to nivolumab in melanoma. Nivolumab plus relatlimab remains a standard-of-care option for patients with advanced melanoma».