New data, designation bolster BeiGene's planned submissions

BeiGene Ltd. (NASDAQ:BGNE) reported response rate data from a pivotal, Chinese Phase II trial of PD-1 inhibitor tislelizumab (BGB-A317) to treat classical Hodgkin's lymphoma (cHL), for which the company is planning a regulatory submission this year. The company also said zanubrutinib (BGB-3111) received Fast Track designation from FDA to treat Waldenström macroglobulinemia, for which BeiGene now hopes to submit an NDA in 1H19 seeking the candidate's accelerated approval.

The single-arm trial of tislelizumab had a primary endpoint of overall response rate (ORR). Among 70 cHL patients with relapsed or refractory disease who failed or were ineligible for autologous stem cell transplantation (ASCT), tislelizumab led to an ORR of 73%, including a complete response rate of 50%, based on independent review. Median duration of response has not yet been reached at a median follow-up of about six months. Full results are to be presented at a future medical meeting...