Study
| Phase 2/3, global, randomized, open-label trial (RELATIVITY-047) |
| Previously untreated, unresectable or metastatic stage III/IV melanoma |
| Nivolumab 480 mg + relatlimab 160 mg q4w vs. Nivolumab 480 mg q4w |
Efficacy
| ORR: 43.7% vs. 33.7% |
| mPFS: 10.2 mos vs. 4.6 mos (HR: 0.79 [0.66-0.95]) |
| 3-yr PFS: 31.8% vs. 26.9% |
| mOS: 51.0 mos vs. 34.1 mos (HR: 0.80 [0.66-0.99]) |
| 3-yr OS: 54.6% vs. 48.0% |
| mPFS2: 29.6 mos vs. 20.3 mos (HR: 0.79 [0.65-0.96]) |
Safety
| Grade ≥3 TRAEs: 22.0% vs. 12.0% |
| Discontinuation due to TRAEs: 17.7% vs. 9.7% |
| Immune-related AEs: hypothyroidism (19.7% vs. 15.0%), rash (13.5% vs. 9.5%), colitis/diarrhea (8.2% vs. 3.9%), hepatitis (6.5% vs. 3.6%), adrenal insufficiency (5.9% vs. 1.1%), pneumonitis (4.2% vs. 2.5%) |
J Clin Oncol 2024;43:1546-1552
http://doi.org/10.1200/JCO.24.01124
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
