ASH: BeiGene presents encouraging data on zanubrutinib in MCL

China’s BeiGene (Nasdaq: BGNE) on Saturday announced clinical data from two ongoing trials of its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, in patients with mantle cell lymphoma (MCL), at the 60th Annual Meeting of the American Society of Hematology (ASH), taking place December 1-4, 2018 in San Diego, USA.

Results from the pivotal Phase II trial of zanubrutinib in Chinese patients with relapsed or refractory (R/R) MCL (ClinicalTrials.gov Identifier: NCT03206970) were featured in an oral presentation, while updated results from the global Phase I trial of zanubrutinib in patients with multiple subtypes of B-cell malignancies, including treatment naïve (TN) and R/R MCL (ClinicalTrials.gov Identifier: NCT02343120), were featured in a poster presentation.

“Taken together, we believe that these two studies provide encouraging evidence for the use of zanubrutinib as a potential therapy in patients with MCL,” said Dr Jane Huang, chief medical officer, hematology, at BeiGene. “The results from 86 patients enrolled in our pivotal Phase II study in Chinese patients with R/R MCL presented today at ASH, provide a thorough look into the data included in our first New Drug Application (NDA) in China for zanubrutinib. Additionally, the results from 48 patients with MCL enrolled in our global Phase I study illustrated consistent outcomes for patients studied outside of China. We are excited by the prospect that zanubrutinib may be a differentiated BTK inhibitor with deep, durable responses for patients with MCL and potentially for other B-cell malignancies,” she added.