BeiGene and CLL Society Partner to Advance Test Before Treat™ Campaign, Promoting Biomarker Testing to Improve Patient Outcomes in CLL
BeiGene (NASDAQ: BGNE) has partnered with CLL Society to launch the Test Before Treat™ campaign, focusing on promoting biomarker testing for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients. The initiative emphasizes the importance of testing before initial treatment and retesting at subsequent treatments to ensure optimal therapy selection.
About 50% of CLL/SLL patients have high-risk molecular features that may limit treatment effectiveness. Approximately 10% have high-risk del(17p) and/or TP53 mutation before starting treatment, while 40% develop these mutations after relapsing. The campaign highlights that genetic profiles can change over time and promotes blood testing to identify mutations for better treatment guidance.
BeiGene (NASDAQ: BGNE) ha collaborato con la CLL Society per lanciare la campagna Test Before Treat™, focalizzandosi sulla promozione del test dei biomarcatori per i pazienti affetti da leucemia linfocitica cronica (CLL) e linfoma linfocitico piccolo (SLL). L'iniziativa sottolinea l'importanza di effettuare test prima del trattamento iniziale e di ripetere i test nei trattamenti successivi per garantire una selezione ottimale della terapia.
Circa il 50% dei pazienti CLL/SLL presenta caratteristiche molecolari ad alto rischio che possono limitare l'efficacia del trattamento. Circa il 10% presenta mutazioni ad alto rischio del(17p) e/o mutazione TP53 prima di iniziare il trattamento, mentre il 40% sviluppa queste mutazioni dopo una ricaduta. La campagna evidenzia che i profili genetici possono cambiare nel tempo e promuove il test del sangue per identificare le mutazioni, al fine di fornire una migliore guida per il trattamento.
BeiGene (NASDAQ: BGNE) se ha asociado con CLL Society para lanzar la campaña Test Before Treat™, enfocándose en promover pruebas de biomarcadores para pacientes con leucemia linfocítica crónica (CLL) y linfoma linfocítico pequeño (SLL). La iniciativa enfatiza la importancia de realizar pruebas antes del tratamiento inicial y de volver a realizar pruebas en tratamientos posteriores para asegurar una selección terapéutica óptima.
Cerca del 50% de los pacientes con CLL/SLL tienen características moleculares de alto riesgo que pueden limitar la efectividad del tratamiento. Aproximadamente el 10% tiene mutaciones de alto riesgo del(17p) y/o mutación TP53 antes de empezar el tratamiento, mientras que el 40% desarrolla estas mutaciones después de recaer. La campaña destaca que los perfiles genéticos pueden cambiar con el tiempo y promueve análisis de sangre para identificar mutaciones que ofrezcan una mejor orientación en el tratamiento.
BeiGene (NASDAQ: BGNE)는 CLL Society와 협력하여 Test Before Treat™ 캠페인을 시작했습니다. 이 캠페인은 만성 림프구성 백혈병 (CLL) 및 소림프구 림프종 (SLL) 환자를 위한 바이오마커 검사를 홍보하는 데 중점을 둡니다. 이 이니셔티브는 초기 치료 전 검사와 이후 치료에서 다시 검사의 중요성을 강조하여 최적의 치료 선택을 보장합니다.
약 50%의 CLL/SLL 환자가 치료 효과를 제한할 수 있는 고위험 분자적 특징을 가지고 있습니다. 초기 치료 시작 전 10%가 고위험 del(17p) 및/또는 TP53 변이를 가지고 있으며, 40%는 재발 후 이러한 변이를 개발합니다. 이 캠페인은 시간이 지남에 따라 유전자 프로필이 변화할 수 있음을 강조하고, 더 나은 치료 지침을 제공하기 위해 변이를 식별하기 위한 혈액 검사를 촉진합니다.
BeiGene (NASDAQ: BGNE) a établi un partenariat avec la CLL Society pour lancer la campagne Test Before Treat™, qui vise à promouvoir le test des biomarqueurs pour les patients atteints de leucémie lymphoïde chronique (CLL) et de lymphome lymphocytaire petit (SLL). Cette initiative souligne l'importance de tester avant le traitement initial et de renouveler les tests lors des traitements suivants afin de garantir une sélection thérapeutique optimale.
Environ 50% des patients CLL/SLL présentent des caractéristiques moléculaires à haut risque qui peuvent limiter l'efficacité du traitement. Environ 10% présentent des mutations à haut risque del(17p) et/ou TP53 avant de commencer le traitement, tandis que 40% développent ces mutations après une rechute. La campagne met en avant le fait que les profils génétiques peuvent évoluer avec le temps et promeut les analyses sanguines pour identifier les mutations en vue d'une meilleure orientation thérapeutique.
BeiGene (NASDAQ: BGNE) hat sich mit der CLL Society zusammengeschlossen, um die Kampagne Test Before Treat™ zu starten, die sich auf die Förderung von Biomarkertests für Patienten mit chronischer lymphatischer Leukämie (CLL) und kleinem lymphatischen Lymphom (SLL) konzentriert. Die Initiative hebt die Bedeutung von Tests vor der ersten Behandlung und von Nachtests bei weiteren Behandlungen hervor, um eine optimale Therapieauswahl sicherzustellen.
Etwa 50% der CLL/SLL-Patienten weisen hochriskante molekulare Merkmale auf, die die Behandlungswirksamkeit einschränken können. Ungefähr 10% weisen vor Beginn der Behandlung hohes Risiko del(17p) und/oder TP53-Mutationen auf, während 40% diese Mutationen nach einem Rückfall entwickeln. Die Kampagne betont, dass sich genetische Profile im Laufe der Zeit ändern können, und fördert Bluttests zur Identifizierung von Mutationen, um eine bessere Behandlungsempfehlung zu geben.
- Partnership with CLL Society strengthens BeiGene's position in the CLL/SLL treatment market
- Campaign aligns with NCCN guidelines recommending BTK inhibitors as preferred treatment
- Initiative potentially increases demand for BeiGene's targeted therapies
- None.
Insights
The partnership between BeiGene and CLL Society to promote biomarker testing represents an important strategic initiative in the CLL/SLL treatment landscape. The campaign addresses a critical gap in patient care, as approximately
The Test Before Treat campaign's focus on personalized medicine through biomarker testing aligns with current NCCN guidelines and the shift away from chemotherapy toward targeted therapies like BTK inhibitors. This is particularly significant given that about
While this partnership may not have an immediate financial impact, it could potentially drive increased adoption of BeiGene's BTK inhibitor treatments and strengthen their market position in the CLL space by promoting better patient identification and targeted therapy selection.
From a market perspective, this educational campaign could strategically benefit BeiGene's position in the competitive BTK inhibitor market. By promoting biomarker testing, BeiGene is positioning itself to capture a larger share of the high-risk CLL patient segment, where targeted therapies are especially crucial.
The partnership with CLL Society, a respected authority in the field, lends credibility to the campaign and could help drive physician adoption of routine biomarker testing. This could lead to increased identification of patients who would benefit most from BTK inhibitors, potentially expanding BeiGene's addressable market.
However, while this initiative shows promise for long-term market development, it's unlikely to have material near-term impact on BeiGene's financial performance or stock value.
About
Campaign highlights national treatment guidelines supporting targeted therapies rather than chemotherapy for improved CLL outcomes
BeiGene and CLL Society launch partnership during the American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 7-10 in
(Graphic: Business Wire)
"While scientific advancements have significantly expanded treatment options for people with CLL, too many patients do not receive the therapies that will work best for them based on their unique disease prognostic parameters. In particular, high-risk CLL, including disease with deletion(17p) and/or TP53 mutations1,2, has vastly different outcomes depending on the choice of therapy,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology, BeiGene. “By partnering with CLL Society for the Test Before Treat campaign, we hope to educate people living with CLL on the importance of biomarker testing and how it can help chart a course for better individualized care and ultimately improved patient outcomes.”
The Test Before Treat campaign highlights how a patient’s genetic profile can change over time and encourages the use of a blood test to identify mutations to provide important insights into disease aggressiveness and help guide treatment.1,3 The campaign is anchored by a real patient’s journey with CLL and how his experience with testing before treatment helped him select a treatment that offered a potentially better outcome.
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For example, about
50% of CLL/SLL patients have high-risk molecular features that may limit the effectiveness of some treatments and increase the likelihood of disease progression if not treated correctly.4,5 -
In fact, of those patients, about
10% of CLL/SLL patients have the high-risk del(17p) and/or TP53 mutation before starting treatment, and about40% of patients will develop del(17p) and/or TP53 mutation after relapsing or not responding to treatment.6,7 This reinforces the critical importance of biomarker testing before initial treatment and retesting at each subsequent treatment to ensure patients get the best treatment at each stage of their disease. -
Unmutated IGHV is present in approximately
40% of patients and is associated with unfavorable prognosis and significantly shorter survival compared to mutated IGHV in patients treated with chemotherapy-based regimens, independent of the stage of the disease.8,9 - Guidelines from the National Comprehensive Cancer Network® (NCCN®) recommend covalent Bruton’s tyrosine kinase (BTK) inhibitors as a preferred treatment for people with CLL/SLL who have or haven’t been treated before and with or without certain genetic mutations (e.g., del(17p) or TP53 mutations).1,10 BTK inhibitors work to shut down (or inhibit) a protein within cancerous B cells called Bruton’s tyrosine kinase.1 By shutting down the BTK protein it can stop sending signals to cancerous B cells, such as those that cause CLL/SLL to grow and spread.1
"Highlighting the important connections between biomarker testing with regard to personalized targeted therapies versus outdated chemotherapy may offer better patient outcomes. This is core to CLL Society’s commitment to addressing the needs of the CLL/SLL communities through education, advocacy, support and research," said Brian Koffman, MDCM (retired), DCFP, FCFP, DABFP, MSEd, Co-Founder, EVP, Chief Medical Officer, CLL Society. "Through our partnership with BeiGene on the Test Before Treat campaign, we hope to further empower patients and healthcare providers with information to advance shared decision-making and optimal care.”
Test Before Treat empowers CLL patients and HCPs to make informed, personalized treatment decisions through a comprehensive awareness initiative. Through targeted digital outreach, direct-to-consumer efforts and tailored in-office HCP resources, Test Before Treat equips patients and HCPs with tools for shared decision-making, ensuring treatments align with each patient’s unique genetic profile to drive better outcomes in CLL management.
To learn more about the Test Before Treat campaign visit https://CLLTestBeforeTreat.org.
About Chronic Lymphocytic Leukemia
A life-threatening cancer of adults, chronic lymphocytic leukemia (CLL) is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow and lymphoid tissues.11,12 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases of leukemia.12,13 Approximately 20,700 new cases of CLL will be diagnosed in the
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines, 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 nearly 11,000 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.
About CLL Society
CLL Society is a leading authority for chronic lymphocytic leukemia patients, families, caregivers and medical professionals. Founded in 2013 by Dr. Brian Koffman, a physician, CLL patient and advocate, and Patricia Koffman, a care partner and advocate, the nonprofit organization addresses the unmet needs of the chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) community through patient education, advocacy, support and research. CLL Society is a registered 501(c)(3) tax-exempt organization. To learn more, visit https://cllsociety.org/.
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 ability of biomarker testing to provide better individualized care and improved patient outcomes; the success of the Test Before Treat™ campaign in educating patients and HCPs; and BeiGene’s plans, commitments, aspirations and goals under the caption “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
To access BeiGene media resources, please visit our News & Media site.
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References:
- NCCN. (2024). NCCN Guidelines for Patients: Chronic Lymphocytic Leukemia. National Comprehensive Cancer Network. https://www.nccn.org/patients/guidelines/content/PDF/cll-patient.pdf
- Nguyen, T. T., Nhu, N. T., Tran, V. K., et al. (2023). Efficacy and Safety of Bruton Tyrosine Kinase Inhibitor Monotherapy Compared with Combination Therapy for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma: A Systematic Review and Meta-Analysis. Cancers, 15(7), 1996. https://doi.org/10.3390/cancers15071996
- Hallek, M., Cheson, B. D., Catovsky, D., et al. (2018). iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood, 131(25), 2745–2760. https://doi.org/10.1182/blood-2017-09-80639
- Leukemia and Lymphoma Society. Chronic Lymphocytic Leukemia. Revised June 2021. Accessed November 5, 2024. https://www.lls.org/sites/default/files/2021-07/PS34_CLL_Booklet_2021.pdf
- Döhner H., Stilgenbauer S., James M.R., et al. 11q deletions identify a new subset of B-cell chronic lymphocytic leukemia characterized by extensive nodal involvement and inferior prognosis. Blood. 1997;89(7):2516-2522.
- Griffin, R., Wiedmeier-Nutor, J.E., Parikh, S.A., et al. (2023). Differential prognosis of single and multiple TP53 abnormalities in high-count MBL and untreated CLL. Blood advances, 7(13), 3169–3179. https://doi.org/10.1182/bloodadvances.2022009040
- Brieghel, C., Aarup, K., Torp, M. H., et al. (2021). Clinical Outcomes in Patients with Multi-Hit TP53 Chronic Lymphocytic Leukemia Treated with Ibrutinib. Clinical Cancer Research, 27(16), 4531–4538. https://doi.org/10.1158/1078-0432.ccr-20-4890
- Gaidano G, Rossi D. The mutational landscape of chronic lymphocytic leukemia and its impact on prognosis and treatment. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):329-337. doi: 10.1182/asheducation-2017.1.329. PMID: 29222275; PMCID: PMC6142556.
- Education, M. (2023, October 16). IGHV and TP53 sequencing: Clinical utility in chronic lymphocytic leukemia (CLL). Mayo Clinic Laboratories.
- Wierda, W. G., Brown, J., Abramson, J. S., et al. (2022). NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 3.2022. Journal of the National Comprehensive Cancer Network: JNCCN, 20(6), 622–634. https://doi.org/10.6004/jnccn.2022.0031
- National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2024. https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq.
- American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
- American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Updated July 1, 2024. Accessed November 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241204999940/en/
BeiGene Investor
Liza Heapes
+1 857-302-5663
ir@beigene.com
BeiGene Media
Kim Bencker
+1 610-256-8932
media@beigene.com
CLL Society Media
Allison DuBois, Mekky Media Relations
920-680-8483
cllsocietypr@mekkymedia.com
Source: BeiGene, Ltd.
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