Clinical Trials

Date: 2018-04-16

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the last patient

Company: BeiGene (China)

Product: tislelizumab (BGB-A317)

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor/immunomodulator. Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It 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.
BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).
Tislelizumab is also being studied in global Phase 3 trials in solid tumors, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma, and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer.

Disease: relapsed or refractory mature T- and natural killer (NK)-cell lymphomas

Therapeutic area: Cancer - Oncology

Country: Canada, China, France, Germany, Italy, Taiwan, USA

Trial details:

The Phase 2, open-label, multi-center trial is designed to assess the efficacy and safety of tislelizumab in patients with relapsed or refractory mature T- and NK-cell neoplasms. Patients will receive 200 mg of tislelizumab every three weeks in each of the trial’s two histological cohorts:
Cohort 1 – patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type); and Cohort 2 – patients with other mature T-cell neoplasms, limited to histologies including peripheral T-cell lymphoma not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma, and anaplastic large cell lymphoma. Approximately 90 patients who had previously received appropriate first-line systemic therapy and experienced disease progression are planned to be enrolled in Greater China (including Hong Kong and Taiwan), Italy, Germany, France and the United States. The primary efficacy endpoint is objective response rate as determined by independent central review. Secondary endpoints include duration of response, progression-free survival, overall survival, rate of complete response or complete metabolic response, and time to response. (NCT03493451)

Latest news:

• On April 16, 2018, BeiGene announced that the first patient was dosed in a global Phase 2 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, in patients with relapsed or refractory mature T- and natural killer (NK)-cell lymphomas.