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BeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024

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BeiGene announced new data presentations at ASH 2024, featuring 21 abstracts including four oral presentations. The five-year follow-up results of the Phase 3 SEQUOIA study showed sustained progression-free survival benefits with BRUKINSA in CLL/SLL patients. Long-term extension studies demonstrated durable responses and favorable safety profiles across multiple B-cell malignancies.

The company also presented promising early data for their BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax. The first-in-human Phase 1/2 CaDAnCe-101 study showed manageable safety and promising efficacy for BGB-16673, while sonrotoclax in combination with BRUKINSA demonstrated promising efficacy in treatment-naïve CLL/SLL patients.

BeiGene ha annunciato nuove presentazioni di dati all'ASH 2024, con 21 abstract tra cui quattro presentazioni orali. I risultati del follow-up a cinque anni dello studio di Fase 3 SEQUOIA hanno mostrato benefici sostenuti nella sopravvivenza libera da progressione con BRUKINSA nei pazienti con CLL/SLL. Gli studi di estensione a lungo termine hanno dimostrato risposte durature e profili di sicurezza favorevoli in diverse neoplasie a cellule B.

La società ha anche presentato dati preliminari promettenti per il loro degradatore di BTK BGB-16673 e l'inibitore di BCL2 sonrotoclax. Lo studio di Fase 1/2 CaDAnCe-101, il primo sull'uomo, ha mostrato una sicurezza gestibile e un'efficacia promettente per BGB-16673, mentre sonrotoclax in combinazione con BRUKINSA ha dimostrato un'efficacia promettente nei pazienti CLL/SLL trattati per la prima volta.

BeiGene anunció nuevas presentaciones de datos en ASH 2024, que incluye 21 resúmenes, de los cuales cuatro fueron presentaciones orales. Los resultados del seguimiento a cinco años del estudio de Fase 3 SEQUOIA mostraron beneficios sostenidos en la supervivencia libre de progresión con BRUKINSA en pacientes con CLL/SLL. Los estudios de extensión a largo plazo demostraron respuestas duraderas y perfiles de seguridad favorables en múltiples neoplasias de células B.

La compañía también presentó datos preliminares prometedores para su degradador de BTK BGB-16673 e inhibidor de BCL2 sonrotoclax. El estudio CaDAnCe-101 de Fase 1/2, el primero en humanos, mostró una seguridad manejable y eficacia prometedora para BGB-16673, mientras que sonrotoclax en combinación con BRUKINSA demostró una eficacia prometedora en pacientes CLL/SLL que no han sido tratados previamente.

BeiGene는 ASH 2024에서 21개의 초록과 4개의 구두 발표를 포함한 새로운 데이터 발표를 했습니다. 3상 SEQUOIA 연구의 5년 추적 결과, CLL/SLL 환자에서 BRUKINSA에 의한 지속적인 무진행 생존 혜택이 나타났습니다. 장기 확장 연구는 여러 B세포 악성종양에서 지속적인 반응과 우수한 안전성 프로파일을 보여주었습니다.

회사는 BTK 분해제 BGB-16673 및 BCL2 억제제 sonrotoclax에 대한 유망한 초기 데이터도 발표했습니다. 인간을 대상으로 하는 1/2상 CaDAnCe-101 연구는 BGB-16673에 대한 관리 가능한 안전성과 유망한 효능을 보여주었으며, sonrotoclax는 BRUKINSA와 함께 초기 치료를 받지 않은 CLL/SLL 환자에서 유망한 효능을 나타냈습니다.

BeiGene a annoncé de nouvelles présentations de données lors de l'ASH 2024, comprenant 21 résumés dont quatre présentations orales. Les résultats du suivi de cinq ans de l'étude de Phase 3 SEQUOIA ont montré des avantages soutenus en matière de survie sans progression avec BRUKINSA chez les patients atteints de CLL/SLL. Des études d'extension à long terme ont démontré des réponses durables et des profils de sécurité favorables dans plusieurs malignités des cellules B.

La société a également présenté des données préliminaires prometteuses pour son dégradeur de BTK BGB-16673 et l'inhibiteur de BCL2 sonrotoclax. La première étude sur l'homme en Phase 1/2 CaDAnCe-101 a montré une sécurité gérable et une efficacité prometteuse pour BGB-16673, tandis que le sonrotoclax en combinaison avec BRUKINSA a démontré une efficacité prometteuse chez les patients CLL/SLL n'ayant jamais été traités.

BeiGene gab neue Datenpräsentationen auf der ASH 2024 bekannt, darunter 21 Abstracts mit vier mündlichen Präsentationen. Die Ergebnisse der fünfjährigen Nachverfolgung der Phase-3-Studie SEQUOIA zeigten anhaltende Vorteile in Bezug auf das progressionsfreie Überleben mit BRUKINSA bei CLL/SLL-Patienten. Langfristige Verlängerungsstudien zeigten nachhaltige Antworten und günstige Sicherheitsprofile bei verschiedenen B-Zell-Malignomen.

Das Unternehmen präsentierte auch vielversprechende frühe Daten für seinen BTK-Degrader BGB-16673 und den BCL2-Inhibitor sonrotoclax. Die erste Phase 1/2-Studie CaDAnCe-101, die am Menschen durchgeführt wurde, zeigte ein handhabbares Sicherheitsprofil und vielversprechende Wirksamkeit für BGB-16673, während sonrotoclax in Kombination mit BRUKINSA vielversprechende Wirksamkeit bei zuvor unbehandelten CLL/SLL-Patienten demonstrierte.

Positive
  • Five-year SEQUOIA study results showed sustained progression-free survival benefits with BRUKINSA
  • Long-term extension studies demonstrated durable responses up to 6.5 years
  • Promising early safety and efficacy data for new BTK degrader BGB-16673
  • Positive initial results for sonrotoclax-BRUKINSA combination therapy
Negative
  • None.

Insights

The ASH 2024 data presentations for BRUKINSA and BeiGene's pipeline demonstrate significant clinical progress. The 5-year SEQUOIA study results show sustained progression-free survival benefits in CLL/SLL patients, while long-term extension studies reveal durable responses lasting up to 6.5 years. Key pipeline developments include promising early data for BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax.

The data strengthens BRUKINSA's market position in B-cell malignancies and validates BeiGene's development strategy. The successful patient transition from acalabrutinib to BRUKINSA without loss of efficacy could drive market share gains. The pipeline compounds, particularly the novel BTK degrader, represent potential future growth drivers and demonstrate BeiGene's innovation in hematologic oncology.

The clinical data presented is remarkably robust. The durability of response in both treatment-naïve and relapsed/refractory settings is particularly impressive. The safety profile remains consistent across long-term follow-up, with no new concerns emerging after extended treatment periods.

The BTK degrader BGB-16673 represents an exciting new approach, potentially offering solutions for patients who develop resistance to traditional BTK inhibitors. The combination of sonrotoclax with BRUKINSA shows promise in achieving deep molecular responses in CLL/SLL, suggesting potential for fixed-duration therapy approaches. This comprehensive development program positions BeiGene strongly in the competitive hematologic oncology landscape.

Five-year results of Phase 3 SEQUOIA study demonstrate durable benefits of BRUKINSA in patients with CLL

Two oral presentations showcase promising safety and efficacy data for BTK chimeric degradation activation compound (CDAC), BGB-16673

Oral presentation highlights continued deep and durable responses and manageable tolerability observed in Phase 1 study of BCL2 inhibitor, sonrotoclax, in combination with BRUKINSA for patients with treatment-naïve CLL/SLL

SAN MATEO, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data across a range of B-cell malignancies and assets, including best-in-class Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib), at the 66th ASH Annual Meeting and Exposition in San Diego, December 7-10. BeiGene has 21 abstracts accepted at ASH 2024, with four selected for oral presentation.

“In the five years since its initial approval, BRUKINSA has become a standard of care for patients facing many B-cell malignancies, and our data featured at ASH demonstrated how long-term follow-up of treatment with BRUKINSA elicited deep and durable responses, including in patients with chronic lymphocytic leukemia and Waldenström’s macroglobulinemia,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “BRUKINSA is just the starting point – pipeline data for our BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax showcase our continued leadership across the hematology landscape and our commitment to bringing innovative medicines to as many people with cancer as possible.”

Presentations Highlight Sustained Progression-Free Survival and Deepening Durable Responses for Patients Treated with BRUKINSA in Treatment-Naïve and Relapsed/Refractory (R/R) Settings

  • Five-year follow-up results from Cohort 1 of the Phase 3 SEQUOIA study showed sustained progression-free survival (PFS) benefit with BRUKINSA in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with no new safety signals observed.
  • Results from the LTE (long-term extension rollover) study of patients with treatment-naïve and R/R CLL also showed that treatment with BRUKINSA as a single agent or as an investigational treatment in combination with obinutuzumab achieved high overall and complete response rates. With a median follow-up of up to 6.5 years, the responses were sustained, and no new safety signals were observed.
  • Results from an LTE study of patients with Waldenström macroglobulinemia (WM) from the Phase 3 ASPEN study, with a median follow-up of up to 5.8 years, demonstrated that treatment with BRUKINSA monotherapy remained durable and the safety/tolerability profile remained favorable.
  • Data from a Phase 2 study showed patients with prior intolerance to acalabrutinib were able to safely and effectively switch to BRUKINSA, with the majority of patients not experiencing recurrence of prior acalabrutinib-intolerance events while maintaining or deepening responses.

Pipeline Data Show Early Safety and Efficacy Across Multiple B-cell Malignancies

  • First-in-human Phase 1/2 CaDAnCe-101 presentations (two oral, one poster) highlighted generally manageable safety and promising efficacy results for BTK degrader, BGB-16673, in patients with R/R CLL/SLL, WM, and R/R indolent non-Hodgkin’s lymphoma. BGB-16673, which induces BTK degradation, is the first and most advanced asset from BeiGene’s chimeric degradation activation compound (CDAC) platform.
  • Oral presentation of the BGB-11417-101 Phase 1 study demonstrated B-cell lymphoma 2 (BCL2) inhibitor sonrotoclax in combination with BRUKINSA continued to show promising efficacy and was generally well-tolerated in patients with treatment-naïve CLL/SLL; this combination is being evaluated in the Phase 3 CELESTIAL-TNCLL study (NCT06073821).

BeiGene Presentations During ASH 2024

Abstract Title

Presentation Details

Lead Author

BRUKINSA

Prospective patient preference study for Bruton tyrosine kinase inhibitor (BTKi) treatment attributes and factors affecting patient shared decision-making CLL/SLL in the USA

Publication #2265

Poster

Dec. 7, 5:30-7:30 p.m.

S. Ailawadhi

Real-world Bruton tyrosine kinase inhibitor (BTKi) utilization and clinical outcomes among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

Publication #2353

Poster

Dec. 7, 5:30-7:30 p.m.

J. Hou

Long-term clinical outcomes in patients with Waldenström macroglobulinemia (WM) who received zanubrutinib in the phase 3 ASPEN study: A report from the zanubrutinib extension study

Publication #3031

Poster

Dec. 8, 6-8 p.m.

S. D’Sa

Patient medication preferences in follicular lymphoma (FL) in the United States (USA): A discrete choice experiment (DCE)

Publication #3655

Poster

Dec. 8, 6-8 p.m.

S. Gaballa

Evaluating reasons for differences in real-world (RW) clinical outcomes among patients with R/R MCL on covalent BTKis

Publication #3732

Poster

Dec. 8, 6-8 p.m.

T. Phillips

Sustained superiority of zanubrutinib vs bendamustine + rituximab in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL): 5-year follow-up of cohort 1 from the SEQUOIA study

Publication #3249

Poster

Dec. 8, 6-8 p.m.

M. Shadman

Deep and sustained responses in patients with CLL treated with zanubrutinib or zanubrutinib + obinutuzumab in phase 1/2 AU-003 and phase 1b GA-101 studies: A report from the zanubrutinib extension study

Publication #3255

Poster

Dec. 8, 6-8 p.m.

C. Tam

Comparative efficacy of zanubrutinib plus obinutuzumab versus last prior treatment in relapsed/refractory follicular lymphoma: Growth modulation index analysis from ROSEWOOD study

Publication #3029

Poster

Dec. 8, 6-8 p.m.

J. Trotman

Impact of novel therapies (NTs) on real-world (RW) clinical outcomes of patients (pts) with relapsed/refractory (R/R) mantle-cell lymphoma (MCL) by race/ethnicity and TP53 mutation status

Publication #5097

Poster

Dec. 9, 6-8 p.m.

T. Phillips

Zanubrutinib is well tolerated and effective in acalabrutinib-intolerant patients with B-cell malignancies

Publication #4632

Poster

Dec. 9, 6-8 p.m.

M. Shadman

Long-term impact of dose interruptions (DIs) of Bruton tyrosine kinase inhibitors (BTKis) on change in IgM levels and clinical outcomes in Waldenström macroglobulinemia (WM)

Publication #4412

Poster

Dec. 9, 6-8 p.m.

J. Trotman

Final analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma

Publication #986

Oral

Dec. 9, 4:45 p.m.

Z. Song

Treatment with zanubrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with another Bruton tyrosine kinase inhibitor in a US community oncology setting

Publication #7763

Online

D. Andorsky

BGB-16673 (BTK CDAC)

Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory (R/R) indolent NHL: Results from the phase 1 CaDAnCe-101 study

Publication #1649

Poster

Dec. 7, 5:30-7:30 p.m.

C. Tam

Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory Waldenström macroglobulinemia: Results from the phase 1 CaDAnCe-101 study

Publication #860

Oral

Dec. 9, 3 p.m.

J. Seymour

Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the phase 1 CaDAnCe-101 study

Publication #885

Oral

Dec. 9, 3:15 p.m.

M. Thompson

BGB-16673, a selective BTK degrader, exhibits deeper inhibition of cancer cell signaling pathways and better efficacy in MCL models

Publication #5833

Online

H. Wang

Sonrotoclax (BCL2 Inhibitor)

Sonrotoclax and zanubrutinib as frontline treatment for CLL demonstrates high MRD clearance rates with good tolerability: Data from an ongoing phase 1/1b study BGB-11417-101

Publication #1012

Oral

Dec. 9, 5:15 p.m.

J. Soumerai

CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive CLL

Publication #6807

Online

P. Patten

BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia

Publication #6289

Online

H. Lee

Cell Therapy Research

iPSC-derived CAR-γδT with SOCS1/CISH/BIM/FAS combinatorial KO demonstrated extended longevity and profound anti-tumor efficacy without cytokine support in preclinical studies

Publication #4790

Poster

Dec. 7, 5:30-7:30 p.m.

J. Yu

Select Investigator-Initiated Trial

Multicenter Phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in treatment-naïve chronic lymphocytic leukemia: 5-year follow up, retreatment outcomes, and impact of MRD kinetics (ΔMRD400)

Publication #1867

Poster

Dec. 7, 5:30-7:30 p.m.

J. Soumerai

About BRUKINSA® (zanubrutinib)

BRUKINSA is an orally available, 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.

BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. The global BRUKINSA clinical development program includes about 6,000 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 70 markets, and more than 100,000 patients have been treated globally.

U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib)

INDICATIONS

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Waldenström’s macroglobulinemia (WM).
  • Mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
  • Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.

The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.

Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information including U.S. Patient Information.

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. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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 continued leadership in hematology and commitment to bringing innovative medicines to as many people with cancer as possible; the safety and efficacy of BeiGene’s pipeline assets; 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 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.

Investor Contact:

Liza Heapes

+1 857-302-5663

ir@beigene.com

Media Contact:

Kim Bencker

+1 610-256-8932

media@beigene.com

To access BeiGene media resources, please visit our News & Media site.

Source: BeiGene, Ltd.

FAQ

What were the key findings from BeiGene's BRUKINSA five-year SEQUOIA study presented at ASH 2024?

The five-year follow-up results showed sustained progression-free survival benefit with BRUKINSA in treatment-naïve CLL/SLL patients, with no new safety signals observed.

How many abstracts did BeiGene (BGNE) present at ASH 2024?

BeiGene presented 21 abstracts at ASH 2024, with four selected for oral presentation.

What were the results of BeiGene's BGB-16673 BTK degrader trials presented at ASH 2024?

The Phase 1/2 CaDAnCe-101 trials showed generally manageable safety and promising efficacy results for BGB-16673 in patients with R/R CLL/SLL, WM, and R/R indolent non-Hodgkin's lymphoma.

What were the outcomes of sonrotoclax combination therapy trials presented by BeiGene at ASH 2024?

The Phase 1 study showed sonrotoclax in combination with BRUKINSA demonstrated promising efficacy and was generally well-tolerated in treatment-naïve CLL/SLL patients.

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