Phase 3 Trial Tests Tyvyt as Esophageal Cancer Therapy
The ORIENT-15 Phase 3 clinical trial evaluating Tyvyt (sintilimab injection) combined with chemotherapies Taxol (paclitaxel) and Platinol (cisplatin) as treatment for esophageal squamous cell carcinoma is now underway.
Tyvyt was developed by Innovent Biologics and Eli Lilly and Company in China as an immune checkpoint inhibitor that will work against PD-1, a protein found on the surface of immune T-cells. When PD-1 joins with PD-L1, the protein produced by cancer cells, the immune system is stopped from destroying the cancerous cells and they grow rapidly. Using immune checkpoint inhibitors like Tyvyt to block PD-1 from interacting with PD-L1 is a way of triggering the immune system to fight off cancer.
Immune checkpoint inhibitors have offered new options for cancer patients to fight their disease. Previous trials have shown that Tyvyt in combination with chemotherapy has the potential to be both safe and effective in treating esophageal cancer. Based on the early results of those trials, ORIENT-15 will work to approve Tyvyt with chemotherapy as a first-line treatment for this cancer.
The trial is taking place in China, and it involves patients whose cancers have advanced locally and have not responded to prior treatments, or patients whose cancers have spread to other organs and they are not candidates for surgery. 640 patients will be randomly chosen to either receive Tyvyt or a placebo, both combined with the chemotherapy drugs.
The study aims to determine whether Tyvyt can prolong survival in patients with esophageal cancer, especially those whose tumor cells produce the PD-L1 factor. That factor is a biomarker that typically indicates a response to PD-1/PD-L1 inhibitors. The trial also hopes to determine whether Tyvyt can slow down disease progression or delay death.
This treatment has already been approved in China as an alternative option for Hodgkin’s lymphoma patients. But it will be particularly useful in Asian countries to treat esophageal squamous cell carcinoma, as incidents of this cancer are much more frequent there. According to Lin Shen, MD of the Beijing Cancer Hospital, patients in Asian countries “have no treatment options other than chemotherapy and radiation therapy.” If the results of the trial are promising, the drug could fulfill what Michael Yu, founder of Innovent, calls “a huge unmet medical need” for countries like China, in which esophageal cancer is the third most common cancer.