Investigators have dosed the first patient in a global Phase 3 trial evaluating the PD-1 inhibitor tislelizumab (BGB-A317) as a first-line therapy for advanced hepatocellular carcinoma (HCC) — the most common form of liver cancer — announced BeiGene, the company developing the investigational drug.
The trial’s primary goal is to determine if tislelizumab is superior to the current standard of care at improving patient survival. It is part of a collaboration between BeiGene and Celgene, which aims to develop this anti-PD-1 antibody for the treatment of solid tumors.
“We are pleased to announce the initiation of this global Phase 3 trial of tislelizumab as part of our collaboration with our partner Celgene,” John V. Oyler, founder, CEO, and chairman of BeiGene, said in a press release.
“We look forward to continuing to leverage our strong presence in Asia and global clinical development organization to broadly develop tislelizumab,” he added.
The study is expected to include 640 patients across 110 clinical centers in the U.S., U.K., Japan, China, Germany, Spain, Czech Republic, France, and Italy. Participants will be randomly assigned to either tislelizumab (200 mg every three weeks) or Bayer’s Nexavar (sorafenib) twice daily.
In addition to the overall survival rate, researchers will also examine other, secondary, measures. These include progression-free survival, overall response rate, duration of response, safety, and health-related quality of life parameters.
“We are hopeful that this Phase 3 trial will establish safety and efficacy of tislelizumab in a head-to-head comparison to sorafenib [Nexavar], the current global standard of care for advanced liver cancer,” said Amy Peterson, MD, chief medical officer for the immuno-oncology department of BeiGene.
Tislelizumab was designed to bind the PD-1 receptor and block its inhibitory effect on immune T-cells, boosting the anti-cancer immune response. This novel antibody is expected to be highly specific and more effective than other currently available versions of PD-1 inhibitors.
In addition to the global Phase 3 trial in HCC, tislelizumab is being evaluated in two pivotal Phase 2 trials in China in patients with relapsed or refractory classical Hodgkin’s lymphoma and urothelial cancer. It is also being tested in a global Phase 3 trial in patients with non-small cell lung cancer (NSCLC).
Results from a Phase 1 trial (NCT02407990) in patients with relapsed or refractory solid tumors have shown that tislelizumab is overall well-tolerated and safe. The drug also showed anti-cancer activity against a broad range of solid tumors types.
“I am excited for the opportunity to evaluate the safety and efficacy of tislelizumab, which has been dosed in more than 850 patients in either monotherapy or combination clinical trials,” said Andrew Zhu, an MD and PhD, director of liver cancer research at Massachusetts General Hospital, professor at Harvard Medical School, and co-lead investigator of the trial.
“Based on preliminary data from a dose expansion cohort of HCC patients in a Phase 1 trial, we are hopeful that tislelizumab will be well-tolerated and exhibit meaningful anti-tumor activity in this Phase 3 trial,” he said.
Patients and physicians seeking additional information on the trial can contact the company by email at: BGBA317clinicaltrials@beigene.com.