Researchers will assess tislelizumab as a second-line treatment for advanced unresectable or metastatic esophageal squamous cell carcinoma, or ESCC. The antibody targets the PD-1 protein associated with many cancers.
The research team will compare tislelizumab’s effectiveness and safety with a chemotherapy that a trial investigator chooses — Taxol (paclitaxel), Taxotere (docetaxel), or irinotecan.
“Patients with advanced unresectable or metastatic esophageal carcinomas face poor prognosis, especially those with squamous histology, due to the extremely aggressive nature of the disease,” Amy Peterson, BeiGene’s chief medical officer of immuno-oncology, said in a press release. An unresectable cancer is one that can’t be removed by surgery. A metastatic cancer is one that has spread to other parts of the body.
“We are hopeful that this Phase 3 trial will establish safety and efficacy of tislelizumab as an important treatment option for these patients,” Peterson said.
Tislelizumab belongs to a class of immunotherapies known as immune checkpoint inhibitors. These medicines are designed to bind to PD-1, boosting immune T-cells’ ability to recognize and kill cancer cellscontaining the protein.
A key difference between tislelizumab and other PD-1 antibodies is that tislelizumab contains an engineered region than minimizes the possibility of negative interactions with other immune cells.
“Treatment options for esophageal squamous cell carcinoma have been limited to chemotherapy,” said Lin Shen, vice president of Beijing Cancer Hospital and the lead trial investigator. “Tislelizumab has shown promising anti-tumor activity and has been generally well-tolerated in clinical trials to date in patients with a variety of cancers, including esophageal cancer, and we are hopeful that data from this Phase 3 trial will lead to a new treatment option where it is so greatly needed.”
BeiGene expects to enroll 450 patients in the global trial. Participants will come from the United States, Greater China, Korea, Japan, Belgium, France, Germany, Italy, Spain and the United Kingdom.
Researchers will randomize patients to receive either 200 mg of tislelizumab every three weeks or one of three single-agent chemotherapies.
The primary measure of tislelizumab’s effectiveness will be whether it lengthens patients’ overall survival rate. Two of the secondary measures are whether it increases the time it takes for patients’ disease to progress and the duration of their response to treatment. Other secondary objectives include whether it improves patients’ health-related quality of life, whether it’s safe and whether patients can tolerate it well.
“We are pleased to be leading the third global Phase 3 study of tislelizumab under our strategic collaboration with Celgene,” said John V. Oyler, BeiGene’s chief executive officer and chairman. “These studies are designed to support regulatory filings both in China and globally, and take advantage of our unique global clinical development organization as well as the recent regulatory reforms in China. In 2018, we look forward to further expanding the development program for tislelizumab and to accomplishing key milestones, including a planned NDA [New Drug Application] submission in China.”
BeiGene is developing tislelizumab as both a stand-alone treatment for solid tumors and blood cancers and in combination with other therapies.
The company is also studying it in Phase 3 trials as a treatment for non-small cell lung cancer and liver cancer and in Phase 2 trials in China as a treatment for relapsed or refractory classical Hodgkin’s lymphoma and urothelial cancer.