Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting

Multiple presentations to showcase the efficacy and safety of BRUKINSA^® across a range of B-cell malignancies

Company to present three-year data from RATIONALE-306 study of TEVIMBRA^® in advanced or metastatic esophageal squamous cell carcinoma (ESCC)

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE #BeiGene–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 – June 4, 2024.

“Our presentations at this year’s ASCO highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “The exciting data we will share during ASCO showcase BRUKINSA’s uniquely differentiated clinical profile and add to the growing body of evidence supporting its role across the blood cancer treatment paradigm.”

BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include:

• A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and
• A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications.

Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include:

• New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and
• Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA.

“Our data at ASCO are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC.”

BeiGene Presentations During ASCO 2024

Abstract Title	Abstract #	Presentation Details	Lead Author
Hematology
Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis (NMA)	7048	Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia   Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT	M. Shadman
Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL)	11158	Session Type and Title: Poster Session – Quality Care/Health Services Research   Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT	M. Krackeler
Risk of hypertension in patients with CLL/SLL who participated in ALPINE: a post hoc analysis	N/A	Online	D. Ramirez
Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated with Bruton tyrosine kinase inhibitors (BTKi): A real-world data study using the Symphony Health Solution database	N/A	Online	T. Kou
Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL	N/A	Online	J. Pinilla-Ibarz
Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma	N/A	Online	B. Shah
Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis	N/A	Online	T. Munir
Clinical and financial burden of mental health (MH) conditions in patients (pts) with low-grade non-Hodgkin lymphoma (LG-NHL)	7072	Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia   Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT	K. Yang
Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)	N/A	Online	S. Gaballa
Real-world Bruton tyrosine kinase inhibitor (BTKi) treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices	N/A	Online	J. Hou
BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia	TPS7090	Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia   Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT	H. Lee
CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL	TPS7087	Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia   Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT	M. Shadman
Solid Tumor/IO
Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): minimum 3-year survival follow-up	4032	Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary   Session Date and Time: June 1 at 1:30-4:30 PM CDT	H. Yoon
BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors	2610	Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy   Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT	L. Yufei
Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study	3599	Session Type and Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal   Session Date and Time: June 1 at 1:30-4:30 PM CDT	K. Ding
Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305	2605	Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy   Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT	D. Serrano
A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors	2585	Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy   Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT	S. Deva
Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.	N/A	Online	C. Zhou

About BRUKINSA® (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

Please see full U.S. Prescribing Information for BRUKINSA® (zanubrutinib), including U.S. Patient Information or visit www.brukinsa.com.

About TEVIMBRA^® (tislelizumab-jsgr)

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Please see full U.S. Prescribing Information for TEVIMBRA® (tislelizumab-jsgr), including Medication Guide.

About Sonrotoclax (BGB11417)

Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations.

About BeiGene

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), and Facebook.

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 the strength and future growth of BeiGene’s oncology portfolio; BeiGene’s ability to develop treatments that address the unmet needs of patients with B-cell malignancies and solid tumors; the versatility of tislelizumab across tumor types; and BeiGene’s plans, commitments, aspirations, and goals under the heading “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, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and 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 Contact:
Liza Heapes

+1 857-302-5663

ir@beigene.com

Media Contact:
Kyle Blankenship

+1 667-351-5176

media@beigene.com