Camrelizumab plus Chemotherapy for Metastatic Esophageal Squamous Cell Cancer

The immune checkpoint inhibitor pembrolizumab combined with chemotherapy was recently approved by the FDA for first-line treatment of esophageal and gastroesophageal junction squamous cell cancer (SCC) and adenocarcinoma. In China, the anti–programmed death receptor 1 (PD-1) antibody camrelizumab is approved in the second-line treatment of esophageal SCC.

Investigators in China now report results of an industry-sponsored, double-blind, placebo-controlled, randomized, phase 3 trial of camrelizumab (200 mg) combined with first-line chemotherapy (paclitaxel and cisplatin every 3 weeks) in advanced esophageal SCC. Of 596 patients, PD-1 ligand (PDL-1) expression by tumor proportion score (TPS) was positive at ≥1% in 55%, 35% underwent prior esophagectomy, and 9% received prior neoadjuvant treatment or chemoradiotherapy.

At a median follow-up of 10.8 months, the coprimary endpoints of overall survival (OS) and progression-free survival (PFS) were improved with camrelizumab-chemotherapy compared with placebo-chemotherapy: OS was a median 15.3 vs. 12.0 months (hazard ratio, 0.70; P=0.001); PFS was a median 6.9 vs. 5.6 months (HR 0.56; P<0.001). Response rate was higher with camrelizumab (72.1% vs. 62.1%). Hazard ratios for OS indicated superior OS for patients with TPS ≥1% compared with <1%.