Innovent Biologics has started testing on patients its Tyvyt, fully human anti-PD-1 therapeutic monoclonal antibody, with generic name sintilimab injection, in combination with capecitabine and oxaliplatin, patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ).
The ORIENT-16 a phase III clinical trial is a randomized, double-blind, multi-center, phase III trial conducted in China. The phase III study will enroll 650 patients. The study follows a phase Ib study that evaluated Tyvyt in combination with chemotherapy in patients with gastric cancer.
“Over the past decade, the treatment of various malignant tumors has progressed rapidly. From traditional chemotherapy to targeted molecular therapy and immunotherapy, the prognosis of cancer patients has been improved remarkably. However, breakthroughs in the treatment of gastric cancer have been few. With the exception of trastuzumab in first-line use for HER-2 positive patients, several phase III clinical trials have failed successively. Based on the efficacy signals and the safety profile from previous trials, we hope to validate the therapeutic potential of sintilimab in combination with chemotherapy in ORIENT-16, a phase III trial,” said Dr. Jianming Xu, a professor from the Chinese PLA General Hospital.
“Gastric cancer is the second most common malignant tumor in China. The development of new agents for the treatment of advanced gastric cancer has been stagnant, and unmet clinical need is huge. Based on the encouraging efficacy signal we have observed in our phase Ib study, we have decided to conduct ORIENT-16, a phase III study in first-line gastric cancer. Our goal is to provide more effective cancer treatment options for the benefit of these patients and for their families,” said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.