An interim analysis of a Phase III study shows that a combination of Innovent’s sintilimab with chemotherapy significantly improves overall survival compared with placebo in the first-line management of patients with advanced gastric cancer.
An interim analysis of a Phase III study shows that a combination of Innovent Biologics’ sintilimab with chemotherapy significantly improves overall survival (OS) compared with placebo in the first-line management of patients with advanced gastric cancer.
Sintilimab is a PD-1 inhibitor developed under a joint collaboration between Eli Lilly and Innovent. Last year, the two companies’ supplemental New Drug Application (sNDA) for sintilimab injection plus gemcitabine and platinum in lung cancer was accepted by China’s National Medical Products Administration (NMPA). The acceptance of this sNDA was based on a data analysis showing the first-line combination was superior to placebo for improving progression-free survival in patients with squamous non-small cell lung cancer.
The most recent ORIENT-16 study enrolled patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study represents the first late-stage trial in China to show that a combination of an anti-PD-1 antibody with chemotherapy results in a significantly prolonged OS when administered as front-line therapy for advanced gastric cancer.
Sintilimab featured a safety profile that was considered consistent with previous reports of the agent. Additionally, there were no new safety signals associated with the sintilimab and chemotherapy combination in the Phase III trial.
The current prognosis of advance gastric cancer is poor, explained Professor Jianming Xu, M.D., from the Fifth Medical Center of People’s Liberation Army General Hospital, who served as the principal investigator of the ORIENT-16 study. “Gastric cancer is one of the most common malignant tumor types globally and nearly half of all cases are diagnosed in China,” explained Xu. “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.”
Although immunotherapy has transformed the treatment landscape for several different types of malignancies, there is still a need for optimal therapies in gastric cancer. As such, findings from the ORIENT-16 study may help address an unmet clinical need in this disease, explained Innovent’s senior vice president of Clinical Development, Dr. Zhou Hui. “These results are very encouraging and confirmed the clinical value of sintilimab plus chemotherapy in the first-line treatment of advanced gastric cancer,” said Hui.
“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, esophageal squamous cell carcinoma, and gastric cancer,” added Hui.
Innovent is following recommendations from the trial’s Independent Data Monitoring Committee (IDMC), which recommends a thorough review of the study data and subsequent filing of an sNDA for sintilimab with China’s Drug Evaluation Center (CDE) of the NMPA.
In addition to the progression of sintilimab with Innovent, Lilly announced a recent clinical trial showed its interleukin-13 inhibitor lebrikizumab significantly improved itch and skin clearance in patients with moderate-to-severe atopic dermatitis. These study findings could make lebrikizumab the company’s next big win in atopic dermatitis, but full results of the clinical trial won’t be available until next year.
