BeiGene Highlights Waldenström’s Macroglobulinemia Innovation at IWWM 2024
BeiGene (NASDAQ: BGNE) announced its participation in the 12th International Workshop on Waldenström's Macroglobulinemia (IWWM) with seven presentations featuring research on BRUKINSA® (zanubrutinib), BTK CDAC degrader BGB-16673, and BCL2 inhibitor sonrotoclax. Key findings include:
1. Long-term safety and efficacy data from ASPEN LTE1 study showing maintained or improved efficacy in ibrutinib-treated patients who switched to BRUKINSA.
2. Preliminary data from CaDAnCe-101 study demonstrating BGB-16673's tolerable safety profile and promising antitumor activity in heavily pretreated patients.
3. Updated results from a Phase 2 study showing BRUKINSA's efficacy in patients intolerant to other BTK inhibitors.
4. Analysis of ASPEN study indicating faster peripheral neuropathy symptom resolution with BRUKINSA compared to ibrutinib.
5. Phase 1 study results showing sonrotoclax's tolerability and encouraging antitumor activity in heavily pretreated R/R WM patients.
BeiGene (NASDAQ: BGNE) ha annunciato la sua partecipazione al 12° Workshop Internazionale sulla Macroglobulinemia di Waldenström (IWWM) con sette presentazioni che mostrano ricerche su BRUKINSA® (zanubrutinib), il degradatore di BTK CDAC BGB-16673 e l'inibitore di BCL2 sonrotoclax. I risultati chiave includono:
1. Dati di sicurezza ed efficacia a lungo termine dallo studio ASPEN LTE1 che evidenziano un'efficacia mantenuta o migliorata nei pazienti trattati con ibrutinib che sono passati a BRUKINSA.
2. Dati preliminari dallo studio CaDAnCe-101 che dimostrano il profilo di sicurezza tollerabile di BGB-16673 e una promettente attività antitumorale in pazienti gravemente pretrattati.
3. Risultati aggiornati da uno studio di Fase 2 che mostrano l'efficacia di BRUKINSA in pazienti intolleranti ad altri inibitori di BTK.
4. Analisi dello studio ASPEN che indica una risoluzione più rapida dei sintomi di neuropatia periferica con BRUKINSA rispetto a ibrutinib.
5. Risultati di uno studio di Fase 1 che mostrano la tollerabilità di sonrotoclax e incoraggianti attività antitumorali in pazienti R/R WM gravemente pretrattati.
BeiGene (NASDAQ: BGNE) anunció su participación en el 12º Taller Internacional sobre Macroglobulinemia de Waldenström (IWWM) con siete presentaciones que presentan investigaciones sobre BRUKINSA® (zanubrutinib), el degradador de BTK CDAC BGB-16673 y el inhibidor de BCL2 sonrotoclax. Los hallazgos clave incluyen:
1. Datos de seguridad y eficacia a largo plazo del estudio ASPEN LTE1 que muestran eficacia mantenida o mejorada en pacientes tratados con ibrutinib que cambiaron a BRUKINSA.
2. Datos preliminares del estudio CaDAnCe-101 que demuestran el perfil de seguridad tolerable de BGB-16673 y prometedora actividad antitumoral en pacientes gravemente pretratados.
3. Resultados actualizados de un estudio de Fase 2 que muestran la eficacia de BRUKINSA en pacientes intolerantes a otros inhibidores de BTK.
4. Análisis del estudio ASPEN que indica una resolución más rápida de los síntomas de neuropatía periférica con BRUKINSA en comparación con ibrutinib.
5. Resultados de un estudio de Fase 1 que muestran la tolerabilidad de sonrotoclax y una alentadora actividad antitumoral en pacientes R/R WM gravemente pretratados.
BeiGene (NASDAQ: BGNE)는 일곱 개의 발표로 구성된 12번째 국제 월덴스트롬 대형 글로불린 혈증 워크숍(IWWM) 참여를 발표했습니다. 발표 내용에는 BRUKINSA®(자누브루티닙), BTK CDAC 분해제 BGB-16673 및 BCL2 억제제 소노로토클락스에 대한 연구가 포함됩니다. 주요 결과는 다음과 같습니다:
1. BRUKINSA로 전환한 ibrutinib 치료 환자들의 유지되거나 개선된 효과를 보여주는 ASPEN LTE1 연구의 장기 안전성 및 효능 데이터.
2. 중증 재치료 환자에서 BGB-16673의 용인 가능한 안전성 프로필과 유망한 항종양 활성을 보여주는 CaDAnCe-101 연구의 예비 데이터.
3. 다른 BTK 억제제에 불내성이 있는 환자에 대한 BRUKINSA의 효능을 보여주는 2상 연구의 업데이트된 결과.
4. BRUKINSA와 ibrutinib 간의 말초신경병증 증상 해결이 더 빠르다는 ASPEN 연구의 분석.
5. 중증 재치료 R/R WM 환자에서 소노로토클락스의 내약성과 고무적인 항종양 활성을 보여주는 1상 연구 결과.
BeiGene (NASDAQ: BGNE) a annoncé sa participation au 12e Atelier International sur la Macroglobulinémie de Waldenström (IWWM) avec sept présentations portant sur la recherche sur BRUKINSA® (zanubrutinib), le dégradateur BTK CDAC BGB-16673 et l'inhibiteur de BCL2 sonrotoclax. Les conclusions clés incluent :
1. Données sur la sécurité et l'efficacité à long terme de l'étude ASPEN LTE1 montrant une efficacité maintenue ou améliorée chez les patients traités par ibrutinib qui sont passés à BRUKINSA.
2. Données préliminaires de l'étude CaDAnCe-101 démontrant le profil de sécurité tolérable de BGB-16673 et une activité antitumorale prometteuse chez des patients fortement prétraités.
3. Résultats mis à jour d'une étude de phase 2 montrant l'efficacité de BRUKINSA chez des patients intolérants à d'autres inhibiteurs de BTK.
4. Analyse de l'étude ASPEN indiquant une résolution plus rapide des symptômes de neuropathie périphérique avec BRUKINSA par rapport à l'ibrutinib.
5. Résultats d'une étude de phase 1 montrant la tolérabilité de sonrotoclax et une activité antitumorale encourageante chez des patients R/R WM fortement prétraités.
BeiGene (NASDAQ: BGNE) kündigte seine Teilnahme am 12. Internationalen Workshop zur Makroglobulinämie von Waldenström (IWWM) mit sieben Präsentationen an, die Forschung zu BRUKINSA® (Zanubrutinib), dem BTK CDAC Degrader BGB-16673 und dem BCL2-Inhibitor Sonrotoclax präsentieren. Wichtige Ergebnisse beinhalten:
1. Langfristige Sicherheits- und Wirksamkeitsdaten aus der ASPEN LTE1-Studie, die eine erhaltene oder verbesserte Wirksamkeit bei Patienten zeigen, die mit Ibrutinib behandelt wurden und zu BRUKINSA gewechselt sind.
2. Vorläufige Daten aus der CaDAnCe-101-Studie, die das tolerierbare Sicherheitsprofil von BGB-16673 und vielversprechende antitumorale Aktivität bei stark vorbehandelten Patienten zeigen.
3. Aktualisierte Ergebnisse einer Phase-2-Studie, die die Wirksamkeit von BRUKINSA bei Patienten zeigen, die gegenüber anderen BTK-Inhibitoren intolerant sind.
4. Analyse der ASPEN-Studie, die auf eine schnellere Lösung der Symptome von peripherer Neuropathie mit BRUKINSA im Vergleich zu Ibrutinib hinweist.
5. Ergebnisse einer Phase-1-Studie zeigen die Tolerierbarkeit von Sonrotoclax und ermutigende antitumorale Aktivität bei stark vorbehandelten R/R-WM-Patienten.
- BRUKINSA demonstrated maintained or improved efficacy in ibrutinib-treated patients who switched to BRUKINSA in the ASPEN LTE1 study
- BGB-16673 showed promising antitumor activity in heavily pretreated patients with BTK inhibitor-exposed relapsed/refractory WM
- BRUKINSA maintained or improved efficacy in patients intolerant to other BTK inhibitors
- BRUKINSA showed faster peripheral neuropathy symptom resolution compared to ibrutinib in the ASPEN study
- Sonrotoclax demonstrated encouraging antitumor activity in heavily pretreated R/R WM patients
- None.
Insights
The presentations at IWWM 2024 highlight BeiGene's significant progress in Waldenström's macroglobulinemia (WM) treatment. Key findings include:
- Long-term data from ASPEN LTE1 shows BRUKINSA maintains or improves efficacy in patients switching from ibrutinib, with rare worsening of adverse events.
- Phase 1 results for BGB-16673 (BTK CDAC degrader) demonstrate a tolerable safety profile and promising activity in heavily pretreated, BTK inhibitor-exposed R/R WM patients, including those with BTK and CXCR4 mutations.
- Phase 2 data on BRUKINSA in BTK inhibitor-intolerant patients shows most adverse events leading to prior intolerance did not recur, with maintained or improved efficacy.
- Sonrotoclax (BCL2 inhibitor) Phase 1 results indicate good tolerability and encouraging preliminary activity in heavily pretreated R/R WM patients.
These findings suggest BeiGene is advancing multiple promising therapies for WM, potentially expanding treatment options for patients with alternatives. The company's focus on addressing unmet needs in this rare cancer could strengthen its position in the hematology-oncology market.
BeiGene's strong presence at IWWM 2024 with seven presentations underscores its commitment to WM research and treatment. This focus on a rare cancer could yield several benefits:
- Market Expansion: Positive data for BRUKINSA in WM, including in BTK inhibitor-intolerant patients, may help capture market share from competitors like ibrutinib.
- Pipeline Value: Promising early-stage data for BGB-16673 and sonrotoclax could enhance BeiGene's pipeline value, particularly if these assets progress to later-stage trials.
- Diversification: Success in WM helps diversify BeiGene's portfolio beyond its primary focus on broader hematological malignancies.
- Regulatory Advantage: Fast Track Designation for BGB-16673 in CLL/SLL could accelerate development and potentially lead to earlier market entry.
While these developments are positive, investors should note that early-stage data requires further validation in larger trials. The impact on near-term financials may be , but the long-term potential in WM treatment could be significant for BeiGene's growth trajectory.
Studies of BRUKINSA® (zanubrutinib), BTK CDAC degrader BGB-16673 and BCL2 inhibitor sonrotoclax featured in invited talks and oral presentations
BeiGene has seven presentations at IWWM 2024, and Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene, will give the opening ceremony keynote, “Innovating for Impact: How BeiGene is Advancing Products and Pipeline to Address Waldenstrom’s Macroglobulinemia and Beyond.”
“Waldenström’s macroglobulinemia is a rare and incurable cancer, and many patients face treatment failure after initial lines of therapy,” Dr. Mobasher said. “Our BTK inhibitor BRUKINSA has become a standard of care for these patients and as shown through our long-term follow-up data at IWWM, continues to demonstrate deep and durable responses with favorable safety. Additional presentations demonstrate our continued commitment to developing and evaluating new treatment options for Waldenström’s macroglobulinemia patients and include results from Phase 1 studies of our BTK CDAC degrader BGB-16673 and BCL2 inhibitor sonrotoclax. We are encouraged by these results and look forward to advancing these assets to help more patients with WM.”
During IWWM, BeiGene research will be shared in two invited talks, three oral presentations and two posters. Key presentations are outlined below.
IWWM Session
|
Session
|
Asset |
Key Findings |
BTK-Inhibitors in WM I (Oct. 18, 11:30 a.m.-12:30 p.m.) |
Oral presentation |
BRUKINSA |
Long-term safety and efficacy data from |
BTK-I Intolerant and Resistant Disease (Oct. 18, 2:30-3:30 p.m.) |
Invited talk |
BGB-16673 |
Preliminary safety and efficacy data from the phase 1 CaDAnCe-101 study demonstrates that BGB-16673 has a tolerable safety profile and shows promising antitumor activity in heavily pretreated patients with BTK inhibitor-exposed relapsed/refractory (R/R) WM, including those with BTK and CXCR4 mutations. BGB-16673 was recently granted Fast Track Designation by the |
Invited talk |
BRUKINSA |
Updated results from a Phase 2 study of WM patients who switched to BRUKINSA after becoming intolerant to other BTK inhibitors, including ibrutinib and acalabrutinib, show that most adverse events (AEs) that led to intolerance did not recur after treatment with BRUKINSA. Additionally, efficacy was maintained or improved in these patients. |
|
WM Poster Presentations & Reception (Oct. 18, 4:30-6:30 p.m.) |
Poster |
BRUKINSA |
An analysis of the Phase 3 ASPEN study demonstrates that peripheral neuropathy (PN) symptom resolution with BTK inhibitors correlates with depth of disease response, with faster symptom resolution with BRUKINSA than ibrutinib in patients achieving PN resolution. |
Poster |
N/A |
Results of a |
|
Plenary Session II (Oct. 19, 9-10 a.m.) |
Oral Presentation |
Sonrotoclax |
Results from the Phase 1 study show that sonrotoclax was generally well tolerated and the preliminary antitumor activity is encouraging in patients with heavily pretreated R/R WM. |
Clinical Trials in Progress for WM II (Oct. 19, 4-5 p.m.) |
Oral presentation |
Sonrotoclax |
Trial-in-progress presentation provides an overview of a Phase 2 study of sonrotoclax in patients with R/R WM, who have been previously treated with a BTK inhibitor therapy or anti-CD20–based systemic therapy. |
About Waldenström’s Macroglobulinemia (WM)
Waldenström’s macroglobulinemia (WM) is a rare B-cell lymphoma that occurs in less than
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.
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
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
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 (
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
Cardiac Arrhythmias
Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in
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 (≥
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
This information is intended for a global audience. Product indications vary by region.
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 BRUKINSA’s ability to provide deep and durable responses with favorable safety for WM patients; BeiGene’s ability to further advance its BTK CDAC degrader BGB-16673 and BCL2 inhibitor sonrotoclax; 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
1 Buske, C, et al. Treatment and outcome patterns in European patients with Waldenström’s macroglobulinaemia: a large, observational, retrospective chart review. The Lancet Haematology 2018; 5: e0299-309. |
2 Lymphoma Research Foundation. Getting the Facts: Waldenström Macroglobulinemia. Accessed March 2022. Available at https://lymphoma.org/wp-content/uploads/2021/12/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf |
3 IWMF. Frequently Asked Questions – Waldenstrom’s Macroglobulinemia. https://iwmf.com/frequently-asked-questions-waldenstrom-macroglobulinemia/ |
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Media:
Kim Bencker
+1 610-256-8932
media@beigene.com
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Source: BeiGene, Ltd.
FAQ
What are the key findings for BRUKINSA in Waldenström's macroglobulinemia presented at IWWM 2024?
What were the results of the CaDAnCe-101 study for BGB-16673 presented at IWWM 2024?
What did the Phase 1 study of sonrotoclax in Waldenström's macroglobulinemia reveal at IWWM 2024?
How many presentations did BeiGene (BGNE) have at the IWWM 2024 conference?
