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

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BeiGene, a global oncology innovator, is set to present new data at the 2024 ASCO Annual Meeting showcasing the efficacy and safety of BRUKINSA and TEVIMBRA across various B-cell malignancies and solid tumors. The company will highlight BRUKINSA's differentiated clinical profile and present data comparing its efficacy with other treatments in chronic lymphocytic leukemia. TEVIMBRA will be featured in multiple presentations, demonstrating its potential across different tumor types. The company's solid tumor development program will be a focal point at the meeting, with new data from the RATIONALE-306 study on TEVIMBRA's efficacy in esophageal squamous cell carcinoma. BeiGene's commitment to addressing unmet patient needs through innovative treatments is evident in the research outcomes they will share at ASCO.
BeiGene, un innovatore globale in oncologia, presenterà nuovi dati durante il Meeting Annuale dell'ASCO del 2024, evidenziando l'efficacia e la sicurezza di BRUKINSA e TEVIMBRA in vari tumori maligni delle cellule B e tumori solidi. L'azienda sottolineerà il profilo clinico differenziato di BRUKINSA e presenterà dati che ne confrontano l'efficacia con altri trattamenti nella leucemia linfocitica cronica. TEVIMBRA sarà oggetto di molteplici presentazioni, dimostrando il suo potenziale in diversi tipi di tumori. Il programma di sviluppo di tumori solidi dell'azienda sarà un punto focale dell'incontro, con nuovi dati dello studio RATIONALE-306 sulla efficacia di TEVIMBRA nel carcinoma squamoso dell'esofago. L'impegno di BeiGene nel rispondere alle esigenze dei pazienti non soddisfatte attraverso trattamenti innovativi è evidente nei risultati della ricerca che condivideranno all'ASCO.
BeiGene, un innovador global en oncología, está preparado para presentar nuevos datos en la Reunión Anual de ASCO 2024, destacando la eficacia y seguridad de BRUKINSA y TEVIMBRA en diversas malignidades de células B y tumores sólidos. La compañía destacará el perfil clínico diferenciado de BRUKINSA y presentará datos que comparan su eficacia con otros tratamientos en la leucemia linfática crónica. TEVIMBRA será destacada en múltiples presentaciones, demostrando su potencial en distintos tipos de tumores. El programa de desarrollo de tumores sólidos de la compañía será un punto focal en la reunión, con nuevos datos del estudio RATIONALE-306 sobre la eficacia de TEVIMBRA en el carcinoma de células escamosas esofágicas. El compromiso de BeiGene para abordar las necesidades no satisfechas de los pacientes a través de tratamientos innovadores es evidente en los resultados de investigación que compartirán en ASCO.
글로벌 종양 혁신 기업인 BeiGene이 2024년 ASCO 연례 회의에서 B세포 악성 종양 및 고형 종양에 대한 BRUKINSA 및 TEVIMBRA의 효능과 안전성에 대한 새로운 데이터를 발표할 예정입니다. 회사는 BRUKINSA의 차별화된 임상 프로필을 강조하고 만성 림프구성 백혈병에서 다른 치료법과의 효능을 비교하는 데이터를 발표할 것입니다. TEVIMBRA는 다양한 종류의 종양을 대상으로 잠재력을 보여주는 여러 발표에서 소개될 예정입니다. 회사의 고형 종양 개발 프로그램은 이번 회의에서 주요 초점이 될 것이며, 식도 편평 세포 암에서 TEVIMBRA의 효과에 대한 RATIONALE-306 연구의 새로운 데이터가 발표됩니다. BeiGene이 ASCO에서 공유할 연구 결과에서 혁신적인 치료를 통해 충족되지 않은 환자의 요구를 해결하려는 회사의 노력이 명확히 드러납니다.
BeiGene, un innovateur mondial en oncologie, est prêt à présenter de nouvelles données lors de la Réunion Annuelle de l'ASCO 2024, mettant en avant l'efficacité et la sécurité de BRUKINSA et TEVIMBRA dans diverses malignités des cellules B et des tumeurs solides. L'entreprise mettra en lumière le profil clinique différencié de BRUKINSA et présentera des données comparant son efficacité à d'autres traitements dans la leucémie lymphoïde chronique. TEVIMBRA sera mise en avant dans plusieurs présentations, démontrant son potentiel sur différents types de tumeurs. Le programme de développement de tumeurs solides de la société sera un point central lors de la réunion, avec de nouvelles données de l'étude RATIONALE-306 sur l'efficacité de TEVIMBRA dans le carcinoma épidermoïde de l'œsophage. L'engagement de BeiGene à répondre aux besoins non satisfaits des patients à travers des traitements innovants est évident dans les résultats de recherche qu'ils partageront à l'ASCO.
BeiGene, ein weltweit führender Innovator in der Onkologie, steht kurz davor, neue Daten auf der Jahresversammlung 2024 der ASCO zu präsentieren, die die Wirksamkeit und Sicherheit von BRUKINSA und TEVIMBRA bei verschiedenen B-Zell-Malignomen und soliden Tumoren zeigen. Das Unternehmen wird das differenzierte klinische Profil von BRUKINSA hervorheben und Daten vorstellen, die dessen Wirksamkeit mit anderen Behandlungen bei chronisch lymphatischer Leukämie vergleichen. TEVIMBRA wird in mehreren Präsentationen vorgestellt, um sein Potenzial bei verschiedenen Tumorarten zu demonstrieren. Das Entwicklungsprogramm für feste Tumoren des Unternehmens wird ein Schwerpunkt des Treffens sein, mit neuen Daten aus der RATIONALE-306-Studie zur Wirksamkeit von TEVIMBRA bei Ösophagus-Plattenepithelkarzinom. BeiGenes Engagement für die Bereitstellung innovativer Behandlungen, die den ungedeckten Bedürfnissen von Patienten entsprechen, wird in den Forschungsergebnissen offensichtlich, die sie bei ASCO teilen werden.
Positive
  • BeiGene will showcase the efficacy and safety of BRUKINSA across B-cell malignancies at the 2024 ASCO Annual Meeting.
  • New data on BRUKINSA will include a network meta-analysis comparing its efficacy with acalabrutinib in chronic lymphocytic leukemia.
  • TEVIMBRA will be featured in multiple presentations at ASCO, highlighting its potential across different tumor types.
  • BeiGene's solid tumor development program will be a key focus, with data from the RATIONALE-306 study on TEVIMBRA's efficacy in esophageal squamous cell carcinoma.
  • The company's commitment to developing innovative treatments for patients with unmet needs is evident in the research outcomes they will share at the meeting.
Negative
  • None.

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)-- 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.

Investor Contact:

Liza Heapes

+1 857-302-5663

ir@beigene.com

Media Contact:

Kyle Blankenship

+1 667-351-5176

media@beigene.com

Source: BeiGene, Ltd.

FAQ

What new data will BeiGene present at the 2024 ASCO Annual Meeting?

BeiGene will present new data on the efficacy and safety of BRUKINSA and TEVIMBRA across various B-cell malignancies and solid tumors.

What will be the focus of BeiGene's presentations at ASCO?

BeiGene will showcase the differentiated clinical profile of BRUKINSA and the potential of TEVIMBRA across different tumor types.

What key highlights will be featured in the presentations at ASCO?

Key highlights include a network meta-analysis comparing BRUKINSA's efficacy with acalabrutinib in chronic lymphocytic leukemia and data from the RATIONALE-306 study on TEVIMBRA's efficacy in esophageal squamous cell carcinoma.

What is the aim of BeiGene's solid tumor development program?

BeiGene's solid tumor development program aims to showcase the potential of TEVIMBRA in treating various solid tumors, including esophageal squamous cell carcinoma.

What does the research outcomes shared at ASCO reflect about BeiGene's commitment?

The research outcomes shared at ASCO reflect BeiGene's commitment to developing innovative treatments that address unmet needs of cancer patients.

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About BGNE

BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment. BeiGene has developed several pharmaceuticals, including tislelizumab, a checkpoint inhibitor, and zanubrutinib.