As reported in the Journal of Clinical Oncology by Ascierto et al, the phase I/IIa RELATIVITY-020 trial part D has shown evidence of activity of the combination of nivolumab and relatlimab in patients with advanced melanoma progressing on anti–PD-1/PD-L1 therapy. The international trial consisted of two parts including patients with disease progression during or within 3 months of one (part D1) or one or more (part D2) anti–PD-1/PD-L1–containing regimens. In part D1 (n = 354), 189 patients received nivolumab/relatlimab at 240/80 mg once every 2 weeks, and 165 received the combination at 480/160 mg once every 4 weeks. In part D2, 164 patients received the regimen at 480/160 mg once every 4 weeks.
Among 351 patients evaluable for response in part D1, objective response was observed in 42 patients (12.0%), with complete response in 15 (4.3%). Stable disease was observed in an additional 100 patients (28.5%) and the disease control rate was 40.5%. Median duration of response was not reached. Among 163 patients evaluable for response in part D2, objective response was observed in 15 (9.2%), with complete response in 4 (2.5%). Stable disease was observed in an additional 50 patients (30.7%) and the disease control rate was 39.9%. Median response duration was 12.8 months. Median progression-free survival in part D1 was 2.1 months, with 6- and 12-month rates of 29.1% and 21.4%. Median progression-free survival in part D2 was 3.2 months, with 6- and 12-month rates of 27.7% and 16.0%. Median overall survival was 14.7 months in part D1, with a 12-month rate of 56.0%, and 17.1 months in part D2, with a 12-month rate of 60.0%.