RELATIVITY-047
Trial question
Is relatlimab-nivolumab combination therapy superior to nivolumab monotherapy in patients with untreated advanced melanoma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 714
714 patients (298 female, 416 male).
Inclusion criteria: patients with previously untreated metastatic or unresectable melanoma.
Key exclusion criteria: uveal melanoma and active, untreated brain or leptomeningeal metastases.
Interventions
N=355 relatlimab-nivolumab (intravenous infusion of 160 mg relatlimab and 480 mg nivolumab in a fixed-dose combination every 4 weeks).
N=359 nivolumab (intravenous infusion of 480 mg every 4 weeks).
Primary outcome
Median progression-free survival
10.1 months
4.6 months
10.1 months
7.6 months
5.0 months
2.5 months
0.0 months
Relatlimab-nivolumab
Nivolumab
Significant
increase ▲
Significant increase in median progression-free survival (10.1 months vs. 4.6 months; HR 1.33, 95% CI 1.09 to 1.61).
Secondary outcomes
Significant increase in progression-free survival for ≥ 1% lymphocyte-activation gene 3 expression (12.6 months vs. 4.8 months; HR 1.33, 95% CI 1.05 to 1.69).
No significant difference in progression-free survival for ≥ 1% programmed death ligand 1 expression (15.7 months vs. 14.7 months; HR 1.05, 95% CI 0.75 to 1.47).
No significant difference in progression-free survival with BRAF mutation (10.1 months vs. 4.6 months; HR 1.35, 95% CI 0.97 to 1.85).
Safety outcomes
No significant difference in health-related QoL.
Conclusion
In patients with previously untreated metastatic or unresectable melanoma, relatlimab-nivolumab was superior to nivolumab with respect to median progression-free survival.
Reference
Hussein A Tawbi, Dirk Schadendorf, Evan J Lipson et al. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34.
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