As reported in the Journal of Clinical Oncology by Paolo Antonio Ascierto, MD, and colleagues, 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.
Study Details
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. Responses and progression-free survival were assessed by blinded independent central review.
Paolo Antonio Ascierto, MD
Key Findings
Among 351 patients evaluable for response in part D1, objective response was observed in 42 patients (12.0%, 95% confidence interval [CI] = 8.8%–15.8%), 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 (95% CI = 12.9 months to not reached).
Among 163 patients evaluable for response in part D2, objective response was observed in 15 (9.2%, 95% CI = 5.2%–14.7%), 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 (95% CI = 6.9–12.9 months).
Median progression-free survival in part D1 was 2.1 months (95% CI = 1.9–3.5 months), with 6- and 12-month rates of 29.1% and 21.4%. Median progression-free survival in part D2 was 3.2 months (95% CI = 1.9–3.6 months), with 6- and 12-month rates of 27.7% and 16.0%.
Median overall survival was 14.7 months (95% CI = 12.4–16.9 months) in part D1, with a 12-month rate of 56.0%, and 17.1 months (95% CI = 13.4–21.0 months) in part D2, with a 12-month rate of 60.0%.
Grade 3 or 4 treatment-related adverse events occurred in 15.0% of patients in part D1 and 12.8% of patients in part D2. Treatment-related serious adverse events occurred in 7.6% and 6.7% of patients. Treatment-related adverse events led to treatment discontinuation in 5.1% and 4.3% of patients. No treatment-related deaths were reported.
The investigators concluded, “Nivolumab and relatlimab had a manageable safety profile and demonstrated durable clinical activity in a proportion of patients with heavily pretreated advanced melanoma with prior progression on anti–PD-1/PD-L1–containing regimens.”
Dr. Ascierto, of Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale,” Naples, is the corresponding author for 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.
