Sintilimab plus Chemotherapy for First-Line Treatment of Metastatic Esophageal Cancer

Immune checkpoint inhibitors are now approved to combine with first-line chemotherapy in the treatment of metastatic esophagogastric cancer. Findings from previous trials led to approval of use of nivolumab or pembrolizumab as second-line treatment in metastatic squamous cancer of the esophagus.

Investigators now report the results of an industry-sponsored, international, randomized trial comparing chemotherapy with paclitaxel plus cisplatin plus either placebo or the anti–PD-1 agent sintilimab in patients with metastatic esophageal squamous cancer. Of 659 patients, the majority had combined positive score (CPS) >5% (74%) or >10% (58%) and a minority had undergone prior surgery (31%) or radiation therapy (19%).

The primary endpoint, overall survival in all patients, was superior in patients treated with sintilimab compared with placebo (median, 16.7 vs. 12.5 months; hazard ratio, 0.63; P<0.001). Overall survival was similarly superior with sintilimab in the subset of patient with CPS >10% (median, 17.2 vs. 13.6 months; HR, 0.64; P=0.002). Survival improvements with sintilimab were seen across subgroups with the exception of the small group (8%) with CPS <1% (HR, 1.32). Progression-free survival in all patients was superior with sintilimab (median, 7.2 vs. 5.7 months; HR, 0.56; P<0.001) as was response rate (66% vs. 45%). No new safety signals were observed.