On March 2, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a pivotal clinical trial of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, in Chinese patients with relapsed or refractory mantle cell lymphoma (MCL) (Press release, BeiGene, MAR 2, 2017, View Source [SID1234517970]). BGB-3111 is also currently being evaluated in a global Phase III study in comparison with ibrutinib for the treatment of patients with Waldenström’s Macroglobulinemia. Schedule your 30 min Free 1stOncology Demo! "We are pleased to announce the beginning of the first pivotal clinical trial of BGB-3111 in China. BGB-3111 has been under clinical investigation since August 2014, and over 300 patients with various B-cell malignancies have been treated with BGB-3111 in Australia, New Zealand, the United States, Korea, and China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The initiation of the first pivotal trial in China with one of our portfolio compounds is an important step towards our goal of advancing innovative cancer treatments for patients in China," commented Lai Wang, Ph.D., Head of China Development.
The Phase II single-arm, open-label, multi-center study is designed to investigate the efficacy and safety of BGB-3111 in patients with relapsed or refractory MCL. The study’s primary endpoint is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug. Secondary endpoints include progression free survival, duration of response, time to response, safety, and tolerability. Professor Jun Zhu of the Beijing Cancer Hospital is the lead principal investigator of the trial.
About BGB-3111
BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays, higher exposure than ibrutinib based on their respective Phase I experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.