BeiGene to Present Clinical Data from Innovative Oncology Portfolio at 2022 ASCO Annual Meeting

Plenary presentation of Phase 3 tislelizumab trial in first-line RM-NPC

Primary analysis of zanubrutinib Phase 2 ROSEWOOD trial in follicular lymphoma

Long-term data from zanubrutinib Phase 3 trial in Waldenström macroglobulinemia

CAMBRIDGE, Mass. & BEIJING & BASEL, Switzerland--()--BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced presentations from the Company’s global clinical development programs in hematologic malignancies and solid tumors at the 2022 Annual Meeting of the American Society of Cancer Oncology (ASCO) being held on June 3-7, 2022.

“We have more than 800 oncology researchers at BeiGene, and these data presentations highlight our important work to deliver potential new therapies to patients worldwide,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We are pleased to have a robust presence at this year’s ASCO and very much look forward to meeting with fellow cancer researchers in person.”

BeiGene presentation highlights:

  • ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia.
  • ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial.
  • RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer.

BeiGene Poster and Oral Presentations at the 2022 ASCO Annual Meeting

Abstract Title and Number

Session

Date and Time
(all times CDT)

Presenting Author

Hematologic Malignancies Clinical Data

Zanubrutinib plus obinutuzumab (Z-O) versus obinutuzumab (O) monotherapy in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): primary analysis of the phase 2 randomized ROSEWOOD trial

Abstract Number: 7510

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM - 11:00 AM
and
3:00 PM - 4:30 PM

Pier L. Zinzani, M.D., Ph.D.

ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) vs ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM)

Abstract Number: 7521

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4

3:00 PM - 4:30 PM
and

8:00 AM - 11:00 AM

Constantine S. Tam, M.D.

Tislelizumab, a PD-1 inhibitor for relapsed/refractory mature T/NK-cell neoplasms: results from a phase 2 study

Abstract Number: 7552

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM - 11:00 AM

Emmanuel Bachy. M.D., Ph.D.

Solid Tumor Clinical Data

RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer

Abstract Number: 384950

Plenary Session

Sunday, June 5
1:00 PM - 4:00 PM

Li Zhang, M.D.

Clinical outcomes associated with tislelizumab in patients (pts) with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (SOR) or lenvatinib (LEN) in RATIONALE-208.

Abstract Number: 4072

Poster session - Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM - 11:00 AM

Julien Edeline, M.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line (1L) therapy for patients (pts) with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study.

Abstract Number: 1031

Poster session - Breast Cancer - Metastatic

Monday, June 6
8:00 AM - 11:00 AM

Keun Seok Lee, M.D., M.S., Ph.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) and tislelizumab (TIS) as first line (1L) therapy for patients (pts) with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC): Preliminary results from a Phase 1b/2 study.

Abstract Number: 4032

Poster session - Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM - 11:00 AM

Keun-Wook Lee, M.D., M.S., Ph.D.

AdvanTIG-206: Anti-TIGIT monoclonal antibody (mAb) ociperlimab (BGB-A1217; OCI) plus anti-programmed cell death protein 1 (PD-1) mAb tislelizumab (TIS) plus BAT1706 versus TIS plus BAT1706 as first-line (1L) treatment for advanced hepatocellular carcinoma (HCC)

Abstract Number: TPS4172

Poster session - Gastrointestinal cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday, June 4
8:00 AM - 11:00 AM

Jia Fan, M.D.

BeiGene Online Only Abstracts at 2022 ASCO Annual Meeting

Abstract Title

Abstract Number

Lead Author

Hematologic Malignancies Clinical Data

A phase 2 expanded access study of zanubrutinib (ZANU) in patients (pts) with Waldenström Macroglobulinemia (WM)

e19522

Jorge J. Castillo, M.D.

Solid Tumor Clinical Data

Clinical outcomes in patients (pts) with previously treated advanced hepatocellular carcinoma (HCC) experiencing hepatitis B virus (HBV) DNA increases during tislelizumab (TIS) treatment in RATIONALE-208.

e16181

Ann-Lii Cheng, M.D.

RATIONALE 302 PRO (encore): Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life

e16095

Eric Van Cutsem, M.D., Ph.D.

Randomized, Phase 3 study of second-line tislelizumab versus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (ESCC), RATIONALE 302: Asia subgroup.

e16107

Kuaile Zhao, M.D.

Updated analysis from a Phase 2 study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable/metastatic microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors.

e14556

Jian Li, M.D., Ph.D

 

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 45 countries and regions, including the United States, China, the EU, Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

About Tislelizumab

Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: https://www.beigene.com/en-us/science-and-product-portfolio/pipeline

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab is currently in regulatory review in first line recurrent/metastatic nasopharyngeal cancer in China and as a potential treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy in the U.S. and in NSCLC and ESCC in Europe. In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the U.S., Europe, and Japan.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA® in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene's advancement, anticipated clinical development, regulatory milestones and commercialization of tislelizumab and zanubrutinib, and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Contacts

Investor
Kevin Mannix
+1 240-410-0129
ir@beigene.com

Media
Kyle Blankenship
+1 667-351-5176
media@beigene.com

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Contacts

Investor
Kevin Mannix
+1 240-410-0129
ir@beigene.com

Media
Kyle Blankenship
+1 667-351-5176
media@beigene.com