Date: 2018-07-22
Type of
information: Interim results
phase: 2
Announcement: interim results
Company: BeiGene (China)
Product: tislelizumab (BGB-A317)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor. BGB-A317 is an investigational humanized monoclonal antibody 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. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
- Tislelizumab is also being studied in global Phase 3 trials in a number of malignancies, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T-and NK-cell lymphomas, and an additional pivotal Phase 2 trial in China in urothelial cancer.
Disease: relapsed or refractory Hodgkin lymphoma
Therapeutic
area: Cancer - Oncology
Country: China
Trial
details:
Latest
news:
- • On July 22, 2018, BeiGene announced preliminary topline results from the independent review of response data from the pivotal Phase 2 trial of tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL).
- The single-arm pivotal trial enrolled 70 patients with cHL who either failed autologous stem cell transplantation (ASCT) or who were ineligible for ASCT. The primary endpoint was overall response rate (ORR) as defined by the Lugano 2014 criteria. Secondary endpoints included progression-free survival (PFS), duration of response (DOR), complete response (CR) rate, time to response, safety, and tolerability. As of the data cutoff, the median follow-up time was approximately 6.0 months.
- A review of responses by an independent review committee, provided in June 2018, demonstrated:
- The ORR was 73 percent, including 50 percent CR, and the median DOR had not been reached.
- Frequency and severity of adverse events were generally consistent with the previously reported Phase 1 safety and tolerability data for tislelizumab, or, in the case of certain immune-related events such as hypothyroidism and fever, consistent with previous reports of other PD-1 antibodies for the treatment of cHL.
- These cHL data, along with additional follow-up data from the clinical trial, are expected to be included in BeiGene’s Biologics License Application (BLA) planned to be filed with the China Drug Administration (CDA) later this year. Full results of the trial are expected to be presented at an upcoming medical conference.
- • On April 21, 2017, BeiGene announced that the first patient was dosed in a pivotal clinical trial of BGB-A317 in Chinese patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The Phase II single-arm, multi-center study is designed to investigate the efficacy and safety of BGB-A317 in patients with relapsed or refractory cHL. The trial’s primary endpoint is the overall response rate as defined by the Lugano Classification. Secondary endpoints include progression-free survival, duration of response, complete response rate, time to response, safety, and tolerability. Professor Jun Zhu of the Peking University Cancer Hospital is the lead principal investigator of the trial.
Is
general: Yes
