A pioneer of domestically-made innovative drugs, the Phase III clinical study of Xinda Biologicals for the treatment of adenocarcinoma of the stomach or gastroesophageal junction reached the primary research endpoint of overall survival

On August 16, Innovent announced that the innovative drug PD-1 inhibitor Daboshu® jointly developed with Eli Lilly combined with chemotherapy (oxaliplatin + capecitabine) for the first-line treatment of unresectable locally advanced and recurrent unresectable Or metastatic gastric or gastroesophageal junction adenocarcinoma, a randomized, double-blind, multi-center phase III clinical trial interim analysis reached the primary research endpoint

Currently in China, the first-line treatment for advanced or metastatic gastric cancer is mainly platinum-containing two- or three-drug chemotherapy.

It is reported that more than 20 clinical studies have been conducted so far to evaluate the anti-tumor effect of Sintilimab on various solid tumors and hematological tumors

This phase III clinical study (ORIENT-16) is a comparison of Sintilimab or placebo, combined with chemotherapy (oxaliplatin + capecitabine) for the first-line treatment of unresectable locally advanced, recurrent or metastatic A randomized, double-blind, multicenter, phase III study of the effectiveness and safety of adenocarcinoma at the gastroesophageal junction (ClinicalTrials.

Interim analysis data based on the independent data monitoring committee (iDMC) showed that for both the intention-to-treat (ITT) population and the PD-L1 positive population, sintilimab combined with chemotherapy compared with placebo combined with chemotherapy significantly prolonged the overall survival of patients At the end of the period (OS), the pre-determined superiority standard is reached, and the safety characteristics are consistent with the previously reported clinical research results of Sintilimab, and there is no new safety signal