Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment

Phase 2 Completed 190 enrolled Innovent Biologics (Suzhou) Co. Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

Efficacy and safety evaluation of IBI308 versus paclitaxel/irinotecan in patients with advanced/metastatic esophageal squamous cell carcinoma after failure of first-line treatment: a randomized, open-label, multicenter, phase 2 study

Timeline

Start: 2017-05-10
Primary completion: 2019-10-02
Completion: 2019-10-02

Outcome

Met primary endpoint

paper The results demonstrate a significant improvement in OS of sintilimab compared to chemotherapy as second-line treatment for advanced or metastatic ESCC. PMID 35165274 ↗

registry analysis (superiority test); Sintilimab vs Chemotherapy; p = 0.032; Hazard Ratio (HR) 0.701 (95% CI 0.504 to 0.972); Log Rank NCT03116152 ↗

Publications

Xu J, Li Y, Fan Q, Shu Y, Yang L, Cui T, Gu K, Tao M, Wang X, Cui C, Xu N, Xiao J, Gao Q, Liu Y, Zhang T, Bai Y, Li W, Zhang Y, Dai G, Ma D, Zhang J, Bai C, Huang Y, Liao W, Wu L, Chen X, Yang Y, Wang J, Ji S, Zhou H, Wang Y, Ma Z, Wang Y, Peng B, Sun J, Mancao C. Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma: a randomized, open-label phase 2 study (ORIENT-2). Nat Commun. 2022 Feb 14;13(1):857. doi: 10.1038/s41467-022-28408-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Irinotecan	Small molecule	180 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	175 mg/m2	Intravenous
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous