BeiGene Announces Clinical Data on Zanubrutinib to Be Presented at the 15th International Conference on Malignant Lymphoma (ICML)

On June 12, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported upcoming data in three oral presentations and one poster presentation on its investigational BTK inhibitor zanubrutinib at the 15thInternational Conference on Malignant Lymphoma (ICML), taking place June 18-22, 2019 in Lugano, Switzerland (Press release, BeiGene, JUN 12, 2019, View Sourcenews-releases/news-release-details/beigene-announces-clinical-data-zanubrutinib-be-presented-15th" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-announces-clinical-data-zanubrutinib-be-presented-15th" rel="nofollow">View Source [SID1234537042]). The company will also host an investor conference call and webcast of mid-2019 clinical data updates on Thursday, June 20 at 8:00 a.m. EDT.

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Oral Presentations:

Title: Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
Session: Focus on Mantle Cell Lymphoma
Date: Wednesday, June 19
Time: 17:45 CEST
Lead Author: Yuqin Song, M.D., Ph.D.

Title: Zanubrutinib for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Session: Session 3 – CLL
Date: Thursday, June 20
Time: 14:45 CEST
Lead Author: Wei Xu, M.D.

Title: Zanubrutinib Plus Obinutuzumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
Session: Focus on Non-Clinical and Early Clinical Data with New Combinations
Date: Thursday, June 20
Time: 17:25 CEST
Lead Author: Constantine S. Tam, M.D.
Poster Presentation:

Title: Updated Safety and Efficacy Data in the Phase 1 Trial of Patients with Mantle Cell Lymphoma (MCL) Treated with Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib (BGB-3111)
Abstract Code: 191
Session: Mantle Cell Lymphomas section
Dates and Times: Wednesday, June 19 (12:00-17:00), Thursday, June 20 (9:00-17:00) and Friday, June 21 (9:00-18:30) CEST
Lead Author: Constantine S. Tam, M.D.

Mid-2019 Clinical Data Update Conference Call and Webcast Information:

BeiGene will host a conference call and webcast on Thursday, June 20 at 8:00 a.m. EDT. Investors and analysts are invited to join the conference call using the following dial-in information:

U.S. Toll-Free: +1 (844) 461-9930
U.S. Toll: +1 (478) 219-0535
Hong Kong Toll-Free: +852 800 279 19250
China Toll-Free: +86 800 914 686
Conference ID: 1790069

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

About Zanubrutinib

Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a pivotal Phase 2 trial in patients with R/R marginal zone lymphoma (MZL); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted by the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of patients with WM, and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy. The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.