Nivolumab plus relatlimab can produce durable responses in patients with advanced melanoma whose disease progressed on anti-PD-1/PD-L1 regimens, according to findings published in the Journal of Clinical Oncology.
These results come from RELATIVITY-020 (ClinicalTrials.gov identifier: NCT01968109), a phase 1/2a trial designed to evaluate relatlimab alone or in combination with nivolumab in patients with advanced solid tumors.
Part D of the trial was designed to assess nivolumab and relatlimab in patients with advanced melanoma who had progression during, or within 3 months of, anti-PD-1/PD-L1-containing regimens. Patients in part D1 had received 1 prior anti-PD-1 regimen, and patients in part D2 had received 2 or more anti-PD-1 or anti-PD-L1 regimens.
Baseline characteristics were similar between the D1 and D2 cohorts. The median age was 63 (range, 17-92) years in the D1 cohort and 62 (range, 21-91) years in the D2 cohort. Most patients had cutaneous melanoma (67.8% and 74.4%, respectively), had stage IV disease (93.8% and 90.9%), had undergone surgery (91.5% and 93.3%), and had received prior systemic therapy (99.7% and 100%).
Patients received nivolumab and relatlimab as a fixed dose combination or in a single-agent vial at 240 mg/80 mg once every 2 weeks or 480 mg/160 mg once every 4 weeks.
The objective response rate (ORR) was 12.0% in the D1 cohort, and the median duration of response was not reached in this group. The ORR was 9.2% in the D2 cohort, and the median duration of response was 12.8 months in this group.
The median progression-free survival (PFS) was 2.1 months in the D1 cohort and 3.2 months in the D2 cohort. This translated to 6-month PFS rates of 29.1% and 27.7%, respectively, and 12-month PFS rates of 21.4% and 16.0%, respectively.
The median overall survival (OS) was 14.7 months in the D1 cohort and 17.1 months in the D2 cohort. The 12-month OS rates were 56% and 60%, respectively.
Grade 3-4 treatment-related adverse events (TRAEs) occurred in 15% of patients in the D1 cohort and 12.8% of patients in the D2 cohort. Treatment discontinuation due to TRAEs occurred in 5.1% and 4.3% of patients, respectively. There were no treatment-related deaths.
“These results provide a valuable data set for understanding nivolumab and relatlimab efficacy and safety in patients with melanoma that previously progressed on PD-(L)1 inhibitor-containing regimens,” the researchers wrote.
Disclosures: This research was supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Ascierto PA, Lipson EJ, Dummer R, et al. Nivolumab and relatlimab in patients with advanced melanoma that had progressed on anti–programmed death-1/programmed death ligand 1 therapy: Results from the phase I/IIa RELATIVITY-020 trial. J Clin Oncol. Published online February 13, 2023. doi:10.1200/JCO.22.02072