SHR‐1316, an anti‐PD‐L1 antibody, plus chemotherapy as the first‐line treatment for advanced esophageal squamous cell carcinoma: A multicentre, phase 2 study

Abstract Background This multicentre, open‐label study evaluated the efficacy and safety of antiprogrammed death ligand 1 antibody SHR‐1316 plus liposomal irinotecan and 5‐fluorouracil as the first‐line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC). Methods Eligible patients received SHR‐1316 (10 mg/kg), liposomal irinotecan (60 mg/m2 for the first cycle, 80 mg/m2 thereafter), and 5‐fluorouracil (2400 mg/m2) every 14 days until disease progression, intolerable toxicity or withdrawal of consent. The primary endpoint was progression‐free survival (PFS). Secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Results We enrolled 23 patients between 11 March 2019 and 31 May 2019. The median follow‐up duration was 15.2 months (95% CI 14.2–16.2). The median PFS was 8.5 months (95% CI 1.2–15.8), and ORR and DCR were 52.2% (95% CI 30.1–74.3) and 73.9% (95% CI 54.5–93.3), respectively. The median OS was 11.6 months (95% CI 6.7–16.6). The most common treatment‐related grade 3–4 adverse events (AEs) were neutropenia (17.4%), nausea (13.0%), and anorexia (13.0%). Treatment‐related serious AEs occurred in two patients. No treatment‐related deaths occurred. Conclusions SHR‐1316 plus liposomal irinotecan and 5‐fluorouracil has a promising efficacy and manageable safety profile, and could be a new first‐line treatment approach for patients with unresectable locally advanced or distant metastatic ESCC.