Clinical Trials

Date: 2018-01-02

Type of information: Treatment of the first patient

phase: 3

Announcement: treatment of the first patient

Company: BeiGene (China)

Product: tislelizumab (BGB-A317)

Action mechanism:

  • monoclonal antibody/immune checkpoint inhibitor. Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody designed to bind to immune checkpoint inhibitor PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells.
  • Tislelizumab is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells.
  • Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Along with two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer, and a global Phase 3 trial in patients with non-small cell lung cancer, tislelizumab is now being evaluated in pivotal trials in four distinct indications.
  • BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

Disease: hepatocellular carcinoma

Therapeutic area: Cancer - Oncology

Country: China, France, Czech Republic, Germany, Italy, Japan, Spain, UK, USA

Trial details:

  • The Phase 3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab versus sorafenib as a potential first-line treatment in patients with unresectable HCC. Approximately 640 patients will be enrolled at approximately 110 cancer centers in China, the United States, Japan, the United Kingdom, Germany, Spain, Czech Republic, France, and Italy. Patients will be randomized to receive either tislelizumab at 200 mg every three weeks or sorafenib at 400 mg twice daily.
  • The trial’s primary endpoint is overall survival, and secondary endpoints include overall response rate, progression free survival, duration of response, time to progression, health-related quality of life, disease control rate, clinical benefit rate, and safety profile.

Latest news:

  • • On January 2, 2018, BeiGene announced that in December 2017 the first patient was dosed in a global Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, in patients with previously untreated advanced hepatocellular carcinoma.

Is general: Yes