Nivolumab plus relatlimab showed a clear benefit in progression-free survival, overall survival and objective response rate.
Patients with melanoma who received treatment with nivolumab plus relatlimab had higher rates of progression-free survival and overall survival compared with patients treated only with nivolumab, according to research presented at the 2023 ASCO Annual Meeting.1
Investigators conducted a clinical trial to determine if nivolumab plus relatlimab treatment demonstrated a statistically significant progression-free survival benefit compared to treatment with nivolumab alone. Data was gathered from the RELATIVITY-047 (NCT03470922) study with an additional 2 year follow-up.
The study cohort included 714 participants, of which 355 received the combined therapy and 359 received only nivolumab. Patients were randomly assigned 1:1 to receive 480 mg nivolumab combined with 160 mg relatlimab, or 480 mg nivolumab every 4 weeks.
An exploratory analysis was performed for melanoma-specific survival, which was defined as death due to melanoma.
Investigators found that nivolumab plus relatlimab showed a clear benefit in progression-free survival, overall survival, and objective response rate over treatment with nivolumab alone. The combined treatment also showed a similar benefit for melanoma-specific survival. Systemic therapy was subsequently administered to 131 patients in the nivolumab plus relatlimab arm, and given to 136 patients in the nivolumab arm.
There were 61 treatment-related adverse events in the nivolumab plus relatlimab arm, and 31 in the nivolumab arm; these treatment-related adverse events led to the discontinuation of treatment. In total, there were 6 treatment-related deaths observed in the study. However, no new deaths have been reported since the last analysis performed by the researchers.
“With 12.3 months of additional follow-up, a consistent benefit was observed with nivolumab plus relatlimab vs nivolumab for progression-free survival, overall survival and objective response rate in the intention-to-treat population, as well as in key patient subgroups,” the authors concluded. “The safety profile of nivolumab plus relatlimab remained consistent with previous reports, with no new or unexpected safety signals.”