Innovent Biologics has announced the final analysis data of ORIENT-15, a Phase III study of sintilimab along with chemotherapy for the first-line oesophageal squamous cell carcinoma (OSCC) treatment.
The global randomised, double-blind, multicentre study enrolled 659 patients with unresectable locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma, during interim analysis.
Patients were divided into the experimental group or control group in a 1:1 ratio.
Overall survival (OS) in all randomised patients and OS in PD-1 / PD-Ligand 1 (PD-L1) positive patients were measured as primary endpoints of the trial.
Median overall survival (mOS) with a 33.9% reduction in risk of death was observed in patients who received sintilimab plus chemotherapy against placebo plus chemotherapy.
A 4.6-month improvement in mOS in all randomised patients, 36.5% reduction in death risk and a 3.9-month improvement in mOS in PD-L1 positive patients were also observed in the study.
In addition, no additional safety signals were observed for the sintilimab and chemotherapy combination with nearly 16 months of extended follow-up.
Peking University Cancer Hospital and Institute professor and the ORIENT-15 study principal investigator Shen Lin said: “The interim analysis of ORIENT-15 met all endpoints, and sintilimab in combination with chemotherapy has been approved by the NMPA to be a first-line treatment option for patients with advanced OSCC.
“In addition, this new indication of sintilimab has been included in the updated China National Reimbursement Drug List (NRDL), benefiting broader patient groups.”
Innovent senior vice-president Dr Hui Zhou said: “In this final analysis, the continued significant OS benefits have been verified in advanced OSCC patients with an acceptable safety profile over time, and further demonstrated that sintilimab as a first-line treatment option will benefit OSCC patients in China.”