BeiGene to Showcase Broad Clinical Portfolio at 2021 ASCO Annual Meeting

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that clinical results and updates from its broad portfolio will be presented at the 2021 Annual Meeting of the American Society of Cancer Oncology (ASCO) being held June 4 – 8, 2021.

“We are pleased to share updates from our growing clinical portfolio across solid tumors and hematologic malignancies at this year’s ASCO, including multiple novel combinations of tislelizumab with our investigational Fc-competent anti-TIGIT-antibody ociperlimab and other therapeutic agents, and the ongoing evaluation of our next-generation BTK inhibitor zanubrutinib,” commented Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We believe that these presentations underscore the breadth and diversity, as well as the remarkable progress and momentum, in BeiGene’s integrated global clinical development program, which we hope will lead to innovative new medicines that offer expanded access and improved affordability for patients worldwide. Through our R&D approach, we share ASCO’s ambition of promoting greater health equity for all patients regardless of where they live.”

To learn more about BeiGene’s research and development and activities around ASCO, please visit https://beigenevirtualexperience.com/. All presentations will be available on Friday, June 4 at 9:00 a.m. ET on ASCO Digital Program.

BeiGene’s Diverse Research and Development Program Designed to Address Unmet Patient Needs

BeiGene takes a diverse approach in its research and development efforts by evaluating different mechanisms of action in prevalent cancer types by biomarker, histology, and line of therapy in a broad, global clinical program. At ASCO 2021, some of the highlights include:

• Initial report from the Phase 3 RATIONALE 302 trial (NCT03430843) of tislelizumab in second-line advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC);
• Initial report from the Phase 2 trial (NCT03736889) of tislelizumab in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors; and
• Long-term follow-up efficacy and safety results from the pivotal Phase 2 trial (NCT03209973) in patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL).

Novel Combination Trials with Tislelizumab Designed to Improve the Clinical Benefit of Checkpoint Inhibition

Although checkpoint inhibition has revolutionized cancer treatment over the past decade, tumor immune escape induced by many mechanisms and factors presents limitations in clinical benefit. To address this issue, BeiGene has been evaluating its potentially differentiated anti-PD-1 antibody tislelizumab in a broad program combining tislelizumab with over 14 therapies or therapeutic candidates, from chemotherapies and targeted therapies to other immunotherapies, and will be presenting results or trial design details on three of these combinations – with BeiGene’s investigational anti-TIGIT-antibody ociperlimab, with chemotherapy, and with investigational anti-HER2 bispecific antibody zanidatamab (ZW25), licensed from Zymeworks, at ASCO 2021.

Ongoing Evaluation of Next-Generation BTK Inhibitor BRUKINSA

BTK inhibition has become an emerging standard of care in B-cell malignancies, but not all patients respond to treatment with BTK inhibitors and adverse events are the most common reason for treatment discontinuation. BeiGene’s next-generation BTK inhibitor BRUKINSA (zanubrutinib) was designed to maximize BTK occupancy and minimize off-target binding for improved efficacy and decreased side effects compared to the first-generation BTK inhibitor.

At ASCO 2021, updated data from the Phase 2 trial (NCT04116437) of zanubrutinib in patients with previously treated B-cell malignancies who were intolerant to prior BTK inhibitors will be available in an abstract. Results from this trial at a prior data cutoff were presented in a poster at the 62^nd ASH Annual Meeting in December 2020, including that most intolerable adverse events patients experienced on the other BTK inhibitors ibrutinib and/or acalabrutinib did not recur with BRUKINSA treatment, and that the vast majority of patients who were evaluable for response at the time of data cutoff maintained or improved their responses on zanubrutinib. Updated results will also be available in a poster at the upcoming EHA2021 Virtual Congress.

BeiGene recently announced positive results from a planned interim analysis in the Phase 3 ALPINE trial comparing BRUKINSA against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA demonstrated superiority in objective response rate per investigator assessment and non-inferiority in ORR per both investigator assessment and independent review committee (IRC). Data pertaining to progression-free survival (PFS), a secondary endpoint of the trial, were immature at the data cutoff for the interim analysis; however, the descriptive summaries of PFS showed an early trend favoring BRUKINSA. In addition, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter compared to ibrutinib, and the overall safety profile of BRUKINSA was consistent with the previously seen profile in its clinical development program.

BeiGene’s Presentations at 2021 ASCO Annual Meeting

Abstract #	Title	Session	Time	Lead Author
4012	RATIONALE 302: Randomized, Phase 3 study of tislelizumab vs chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma.	Poster Discussion Session, Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary	Friday, June 4 at 9:00 a.m. ET	Lin Shen, M.D. Peking University Cancer Hospital and Institute, China
9102	RATIONALE-307: Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients aged ≥65.	Lung Cancer—Non-Small Cell Metastatic	Friday, June 4 at 9:00 a.m. ET	Jie Wang, M .D. Chinese Academy of Medical Sciences and Peking Union Medical College, China
2569	A Phase 2 study of tislelizumab monotherapy in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high/mismatch repair deficient solid tumors.	Developmental Therapeutics—Immunotherapy	Friday, June 4 at 9:00 a.m. ET	Jian Li, M.D. Beijing Cancer Hospital, China
9069	The Effects of Tislelizumab Treatment on the Health-Related Quality of Life of Non−Small Cell Lung Cancer Patients Who Progressed on a Prior Platinum-Containing Regimen.	Lung Cancer—Non-Small Cell Metastatic	Friday, June 4 at 9:00 a.m. ET	Caicun Zhou, M.D., Ph.D. Shanghai Pulmonary Hospital, Tongji University School of Medicine, China
3109	PARALLEL 303: Phase 2 randomized study of pamiparib vs placebo as maintenance therapy in patients (pts) with inoperable locally advanced or metastatic gastric cancer that responded to platinum-based first-line (1L) chemotherapy.	Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology	Friday, June 4 at 9:00 a.m. ET	Fortunato Ciardiello, M.D., Ph.D. Second University of Naples, Italy
1087	A Phase 2 study of pamiparib in the treatment of patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutation.	Breast Cancer—Metastatic	Friday, June 4 at 9:00 a.m. ET	Tao Sun, M.D. Liaoning Cancer Hospital and Institute, China
2583	AdvanTIG-105: Phase 1 dose-escalation study of anti-TIGIT monoclonal antibody ociperlimab (BGB-A1217) in combination with tislelizumab in patients with advanced solid tumors.	Developmental Therapeutics—Immunotherapy	Friday, June 4 at 9:00 a.m. ET	Sophia Frentzas, M.D. Monash Health, Monash University School of Medical and Health Sciences, Australia
TPS5595	AdvanTIG-202: A Phase 2 study investigating anti-TIGIT monoclonal antibody ociperlimab plus anti-PD-1 monoclonal antibody tislelizumab in patients with previously treated recurrent or metastatic cervical cancer.	Gynecologic Cancer	Friday, June 4 at 9:00 a.m. ET	Lingying Wu, M.D., Ph.D. Chines Academy of Medical Sciences, China
TPS4150	AdvanTIG-203: A randomized Phase 2 study comparing anti-TIGIT ociperlimab plus tislelizumab vs tislelizumab plus placebo as second-line treatment in patients with advanced or recurrent esophageal squamous cell carcinoma expressing programmed death-ligand 1	Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary	Friday, June 4 at 9:00 a.m. ET	Ruihua Xu, M.D., Ph.D. Sun Yat-Sen University Cancer Center, China
TPS9128	AdvanTIG-302: Anti-TIGIT monoclonal antibody ociperlimab plus tislelizumab vs pembrolizumab in programmed death ligand 1 selected, previously untreated, locally advanced, unresectable, or metastatic non-small cell lung cancer	Lung Cancer—Non-Small Cell Metastatic	Friday, June 4 at 9:00 a.m. ET	Mark A. Socinski, M.D. AdventHealth Cancer Institute
TPS2656	Zanidatamab, an anti-HER2 bispecific antibody, plus chemotherapy with/without tislelizumab as first-line treatment for patients with advanced HER2-positive breast cancer or gastric/ gastroesophageal junction adenocarcinoma: A Phase 1B/2 trial-in-progress	Developmental Therapeutics—Immunotherapy	Friday, June 4 at 9:00 a.m. ET	Keun Wook Lee, M.D., Ph.D. Seoul National University Hospital, South Korea
e19506	Preliminary results of the phase 2 study of zanubrutinib in patients with previously treated B-cell malignancies intolerant to ibrutinib and/or acalabrutinib	Abstract Only	N/A	Mazyar Shadman, M.D. University of Washington, Seattle
e19507	Tislelizumab (BGB-A317) for relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL): long-term follow-up efficacy and safety results from a phase 2 study	Abstract Only	N/A	Yuqin Song, M.D., Ph.D. Beijing Cancer Hospital, China

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 team of approximately 2,300 colleagues dedicated to advancing more than 80 clinical trials involving more than 13,000 patients. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. 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. The Company currently markets three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and 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 and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations, including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

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 committed to expediting the development of our diverse pipeline of novel therapeutics through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for two billion more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 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 drug candidates and medicines in its broad portfolio, 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 the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q 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.

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