BeiGene announces preliminary topline results of Hodgkin's Lymphoma trial
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. The single-arm pivotal trial enrolled 70 patients with cHL who either failed autologous stem cell transplantation or who were ineligible for ASCT. The primary endpoint was overall response rate as defined by the Lugano 2014 criteria. Secondary endpoints included progression-free survival, duration of response, complete response rate, time to response, safety, and tolerability. As of the data cutoff, the median follow-up time was approximately 6 months. A review of responses by an independent review committee, provided in June 2018, demonstrated: the ORR was 73%, including 50% 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 planned to be filed with the China Drug Administration later this year. 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.