Nivolumab Plus Relatlimab Demonstrates Long-Term Efficacy, Safety Among Newly Diagnosed Patients With Advanced Unresectable Melanoma

According to long-term follow-up results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma. 

As previously reported, “nivolumab plus relatlimab fixed dose combination was approved for the treatment of patients with metastatic melanoma based on superior progression-free survival (PFS) versus nivolumab monotherapy,” stated Evan Lipson, MD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, and coauthors. “Here we report updated results from the RELATIVITY-047 trial with a minimum of 4 years of follow-up.” 

In this study, 714 newly diagnosed patients with unresectable stage III or stage IV melanoma were randomized on a 1-to-1 basis to receive 480 mg of nivolumab either alone (n = 359) or in combination with 160 mg of relatlimab once every 4 weeks (n = 355). The primary end point was PFS. Key secondary end points included overall survival (OS), objective response rate (ORR), melanoma-specific survival, and safety. 

At a median follow-up of 34.9 months, the 4-year PFS rate was 30.6% in the nivolumab plus relatlimab arm and 23.6% in the nivolumab monotherapy arm. The 4-year OS rates were 52% and 42.8%, respectively. The ORR was 43.9% in the nivolumab plus relatlimab arm and 33.4% in the nivolumab monotherapy arm. The 4-year melanoma-specific survival rate was 59.7% in the nivolumab plus relatlimab arm and 49.6% in the nivolumab monotherapy arm. No new safety signals were identified.

“With 4 years of follow-up, nivolumab plus relatlimab demonstrated durable improvement in outcomes versus nivolumab monotherapy for patients with previously untreated advanced melanoma,” concluded Dr Lipson et al. “The durable benefit observed comes at a lower toxicity cost compared with other immuno-oncology combinations.” 

Source: 

Lipson EJ, Hodi FS, Tawbi H, et al. Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. Eur J Cancer. Published online: June 3, 2025. doi: 10.1016/j.ejca.2025.115547