Combination therapy with nivolumab and relatlimab prolongs progression-free survival compared with nivolumab alone among patients with previously untreated, unresectable or metastatic melanoma, according to a study scheduled to be presented at the annual meeting of the American Society of Clinical Oncology, held virtually from June 4 to 8.
Evan J. Lipson, M.D., from the Johns Hopkins Kimmel Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy in Baltimore, and colleagues conducted a multicenter randomized phase II/III trial involving 714 patients with previously untreated, unresectable or metastatic melanoma. Patients were randomly assigned to receive a fixed-dose combination of nivolumab and relatlimab or nivolumab alone (355 and 359 patients, respectively). The primary end point was progression-free survival.
During a median follow-up of 13.2 months, the researchers found that median progression-free survival was significantly longer in the combination group versus the nivolumab-alone group (10.1 versus 4.6 months; hazard ratio, 0.75). At 12 months, progression-free survival rates were 47.7 and 36.0 percent, respectively. Across key prespecified subgroups, progression-free survival favored the combination group. The incidence of grade 3/4 treatment-related adverse events (TRAEs) was 18.9 and 9.7 percent in the combination group and the nivolumab-alone group, respectively. TRAEs resulted in treatment discontinuation in 14.6 and 6.7 percent of patients, respectively.
“Combination therapy with nivolumab and relatlimab is a potential novel treatment option for patients with previously untreated, unresectable, or metastatic melanoma,” Lipson said in a statement. “This is the first phase III study to validate inhibition of the lymphocyte-activation gene 3 immune checkpoint as a therapeutic strategy for patients with cancer.”
Several authors disclosed financial ties to biopharmaceutical companies, including Bristol Myers Squibb, which manufactures nivolumab and relatlimab and funded the trial.
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