In an extended analysis of the phase II/III RELATIVITY-047 trial reported in the Journal of Oncology, Tawbi et al found a significant overall survival benefit with nivolumab/relatlimab vs nivolumab in previously untreated patients with unresectable advanced stage III or IV melanoma.
The initial report from the trial showed that nivolumab/relatlimab significantly improved progression-free survival vs nivolumab, with a clinically meaningful but nonsignificant improvement in overall survival and a numerically higher objective response rate.
Study Details
In the global trial, 714 patients were randomly assigned to receive nivolumab at 480 mg and relatlimab at 160 mg as a fixed-dose combination (n = 355) or nivolumab at 480 mg every 4 weeks. The current analysis describes outcomes after a median follow-up of 33.8 months (range = 0.3–64.2 months).
Key Findings
Median overall survival was 51.0 months (95% confidence interval [CI] = 34.0 months to not reached) with nivolumab/relatlimab vs 34.1 months (95% CI = 25.2–44.7 months) with nivolumab alone (hazard ratio [HR] = 0.80, 95% CI = 0.66–0.99). Rates at 3 years were 54.6% (95% CI = 49.2%–59.6%) vs 48.0% (95% CI = 42.7%–53.1%). Median melanoma-specific survival was not reached (95% CI = not reached to not reached) in the nivolumab/relatlimab group vs 46.7 months (95% CI = 34.1 months to not reached) in the nivolumab group (HR = 0.75, 95% CI = 0.60–0.94).
Median progression-free survival was 10.2 months (95% CI = 6.5–15.4 months) in the nivolumab/relatlimab group vs 4.6 months (95% CI = 3.5–6.5 months) in the nivolumab group (HR = 0.79, 95% CI = 0.66–0.95). The rate at 3 years was 31.8% vs 26.9%. The objective response rate was 43.7% vs 33.7%.
No new or unexpected safety signals were identified.
The investigators concluded: “Overall, at 3-year follow-up, the benefit observed with nivolumab plus relatlimab compared with nivolumab in patients with advanced melanoma was sustained, with the overall survival hazard ratio 95% CI upper bound now < 1. This benefit is accompanied by a safety profile consistent with previous reports.”
Hussein A. Tawbi, MD, PhD, of The University of Texas MD Anderson Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Bristol Myers Squibb. For full disclosures of the study authors, visit ascopubs.org.
