Sintilimab regimen extends OS in gastric, gastroesophageal junction adenocarcinoma
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The addition of sintilimab to first-line chemotherapy extended OS among patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, according to topline results of a randomized phase 3 trial.
Sintilimab (Innovent Biologics/Eli Lilly) is a PD-1 inhibitor.
The ORIENT-16 study assessed whether the addition of sintilimab to first-line oxaliplatin and capecitabine would improve outcomes for patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
OS in the intention-to-treat population and among those with PD-L1-positive disease served as the primary endpoint.
Results of an interim analysis showed the sintilimab-chemotherapy combination significantly improved survival for both groups.
Sintilimab exhibited a safety profile consistent with reports from prior studies of the agent. Researchers observed no new safety signals.
Complete results of ORIENT-16 will be submitted for presentation at a medical meeting.
“Gastric cancer is one of the most common malignant tumor types globally and nearly half of all cases are diagnosed in China. The prognosis of advanced gastric cancer is very poor,” principal investigator Jianming Xu, MD, of Fifth Medical Center of People’s Liberation Army General Hospital in Beijing, said in an Innovent Biologics-issued press release. “Currently, chemotherapy is the primary treatment option and targeted agents have offered limited benefit. The results of the ORIENT-16 study have the potential to bring a new and more effective treatment option to people with gastric cancer.”
Sintilimab is not approved for use in the United States. The agent is approved in China for treatment of certain patients with Hodgkin lymphoma, non-small cell lung cancer or hepatocellular carcinoma.
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