Nivolumab and relatlimab: Manageable safety profile, durable clinical activity in proportion of patients with heavily pretreated advanced melanoma with prior progression on anti–PD-(L)1-containing regimens
October 19, 2023
Abstract
PURPOSE
Nivolumab and relatlimab activity in advanced melanoma with prior progression on anti–programmed death-1/programmed death ligand 1 (PD-(L)1)-containing regimens is under investigation. RELATIVITY-047 demonstrated significantly improved progression-free survival (PFS) for nivolumab and relatlimab over nivolumab in previously untreated advanced melanoma.
METHODS
The phase I/IIa, open-label RELATIVITY-020 trial part D assessed efficacy and safety of nivolumab and relatlimab in advanced melanoma with progression during, or within 3 months of, 1 (D1) or ≥ 1 (D2) anti–PD-(L)1-containing regimens. Safety was a primary end point. Objective response rate (coprimary end point) and PFS by blinded independent central review (BICR) were assessed.
RESULTS
Five hundred eighteen patients (D1 = 354; D2 = 164) received nivolumab and relatlimab. Among evaluable patients, the objective response rate by BICR was 12.0% (95% CI, 8.8 to 15.8) in D1 (n = 351) and 9.2% (95% CI, 5.2 to 14.7) in D2 (n = 163). Responses appeared to be enriched among patients with tumors expressing programmed death ligand 1 or lymphocyte activation gene 3; however, responses were observed regardless of programmed death ligand 1 and lymphocyte activation gene 3 expression (1%). The median duration of response was not reached (95% CI, 12.9 to not reached) in D1 and 12.8 months (95% CI, 6.9 to 12.9) in D2. The median PFS by BICR was 2.1 months (95% CI, 1.9 to 3.5) in D1 and 3.2 months (95% CI, 1.9 to 3.6) in D2; the 6-month PFS rate was 29.1% (95% CI, 24.2 to 34.1) and 27.7% (95% CI, 20.5 to 35.4), respectively. The grade 3-4 treatment-related adverse event incidence was 15.0% in D1 and 12.8% in D2. One case of grade 3 myocarditis and no treatment-related deaths occurred across part D.
CONCLUSION
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-(L)1-containing regimens.
Source:
Ascierto, P. A., Lipson, E. J., Dummer, R., Larkin, J., Long, G. V., Sanborn, R. E., Chiarion-Sileni, V., Dréno, B., Dalle, S., Schadendorf, D., Callahan, M. K., Nyakas, M., Atkinson, V., Gomez-Roca, C. A., Yamazaki, N., Tawbi, H. A., Sarkis, N., Warad, D., Dolfi, S., … Grob, J.-J. (2023). 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. Journal of Clinical Oncology, 41(15), 2724–2735. https://doi.org/10.1200/jco.22...