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August 16, 2021

Innovent’s sintilimab meets primary goal in Phase III gastric cancer trial

Innovent intends to file a supplemental new drug application with the Chinese regulatory agency for sintilimab in gastric cancer.

Innovent Biologics has reported that its sintilimab plus chemotherapy met the predefined primary goal of Phase III ORIENT-16 clinical trial as first-line treatment for unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Co-developed by Innovent and Eli Lilly and marketed as Tyvyt (sintilimab injection) in China, sintilimab is an immunoglobulin G4 monoclonal antibody.

It attaches to and hinders programmed cell death protein 1 (PD-1) molecules or PD-Ligand 1 (PD-L1) pathway on the surface of T-cells and reactivates T-cells to destroy cancer cells.

The randomised, double-blind, multi-centre Phase III clinical trial analysed sintilimab plus chemotherapy regimen of oxaliplatin and capecitabine versus placebo plus chemotherapy for the treatment of gastric or GEJ adenocarcinoma.

Overall survival in all randomised, as well as in PD-L1 positive subjects was the trial’s primary goal.

According to the interim analysis data from the trial, sintilimab plus chemotherapy showed a statistically significant improvement in OS versus placebo in the intention-to-treat (ITT) arm and PD-L1 positive arm.

Furthermore, sintilimab’s safety profile in the trial was in line with that seen in earlier trials of the drug. No new safety signals linked to the combination therapy were observed.

According to the advice of the independent data monitoring committee (IDMC) of the trial, Innovent intends to review these data.

The company also plans to submit a supplemental new drug application (sNDA) for sintilimab to the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China.

Innovent Biologics Clinical Development senior vice-president Dr Zhou Hui said: “These results are very encouraging and confirmed the clinical value of sintilimab plus chemotherapy in the first-line treatment of advanced gastric cancer.

“Today, sintilimab is one of a few PD-1 inhibitors that has shown to be efficacious in the first-line treatment of five major types of cancer – non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, hepatocellular carcinoma, oesophageal squamous cell carcinoma, and gastric cancer.”

Earlier this month, Innovent reported that its antibody therapy, IBI306, met the primary goal of the Phase III CREDIT-2 trial for heterozygous familial hypercholesterolemia in Chinese patients.

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