For patients with previously untreated, advanced esophageal squamous cell carcinoma, treatment with nivolumab plus chemotherapy or nivolumab plus ipilimumab results in significantly longer overall survival than chemotherapy alone, according to a study published in the Feb. 3 issue of the New England Journal of Medicine .

Yuichiro Doki, M.D., from the Osaka University Graduate School of Medicine in Japan, and colleagues conducted an open-label, phase 3 trial involving 970 adults with previously untreated, unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma who were randomly assigned to receive nivolumab plus chemotherapy, nivolumab plus the monoclonal antibody ipilimumab, or chemotherapy alone in a 1:1:1 ratio.

The researchers found that at a minimum follow-up of 13 months, overall survival was significantly longer with nivolumab plus chemotherapy than chemotherapy alone among patients with tumor-cell programmed death ligand 1 (PD-L1) expression of 1 percent or greater (median 15.4 versus 9.1 months; hazard ratio, 0.54) and in the overall population (median, 13.2 versus 10.7 months; hazard ratio, 0.74). Significantly longer overall survival was also seen with nivolumab plus ipilimumab than with chemotherapy alone among patients with tumor-cell PD-L1 expression of 1 percent or more (median, 13.7 versus 9.1 percent; hazard ratio, 0.64) and in the overall population (median, 12.7 versus 10.7 months; hazard ratio, 0.78). Among patients with tumor-cell PD-L1 expression of 1 percent or greater, nivolumab plus chemotherapy, but not nivolumab plus ipilimumab, was associated with a significant progression-free survival benefit over chemotherapy alone.

"Overall survival favored the nivolumab-containing regimens across most of the prespecified subgroups," the authors write.

The study was funded by Bristol Myers Squibb and Ono Pharmaceutical. Bristol Myers Squibb is the manufacturer of nivolumab.

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