Results from subanalyses of RATIONALE-303 and -304 add to the growing body of data on tislelizumab as a potential treatment for non-small cell lung cancer

Biomarker studies shed light on patient characteristics driving improved response to PD-(L)1 inhibitors

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 that clinical results, as well as biomarker data, from its immuno-oncology program in solid tumors will be presented at the American Academy for Cancer Research (AACR) Annual Meeting 2022. The AACR meeting will take place April 8-13, 2022, as a hybrid event in New Orleans and in a virtual format.

“Data at AACR this year build on the growing body of clinical evidence supporting the potential use of tislelizumab for the treatment of non-small cell lung cancer,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, at BeiGene. “Through biomarker analyses in patients with solid tumors, we are also beginning to better understand the tumor characteristics that may predict response to tislelizumab and help improve treatment outcomes for patients. We look forward to sharing more details with the medical community in New Orleans.”

To bring forth potential new treatment options and uncover further insights into checkpoint inhibition in solid tumors and hematological malignancies, BeiGene is evaluating tislelizumab, a potentially differentiated anti-PD-1 antibody, in a broad clinical program, including 17 Phase 3 trials and four pivotal Phase 2 trials, and in collaboration with Novartis.

Growing Body of Data on Tislelizumab in Lung Cancer

RATIONALE-303 and -304 are both Phase 3 studies evaluating tislelizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC). Patient subgroup analyses from these studies will be presented at AACR. Results from these subanalyses reflect and support earlier safety and efficacy findings from those studies.

Additional analyses of early-stage clinical studies evaluating potential biomarkers (tumor mutational burden and gene hyper-amplification) and patient characteristics (co-enrichment of CD8 T cells and macrophages) that may predict response to tislelizumab will be presented.

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.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment in seven indications, including multiple approvals in NSCLC. Tislelizumab has been submitted for regulatory review in two additional indications in China and as a potential treatment for unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy in the US, 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 US, EU 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 United States, China, the EU and 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 FDA review, BeiGene and Novartis announced two new agreements in December 2021 granting Novartis an option to co-develop, manufacture, and commercialize BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development and adding five approved Novartis oncology products to the BeiGene product portfolio 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 non-small cell lung cancer (NSCLC), BeiGene's advancement, anticipated clinical development, regulatory milestones and commercialization of tislelizumab, 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 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.

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