BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024
BeiGene announced it will present new data from its hematology portfolio at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June 13-16, 2024.
Highlights include 28 abstracts, with four oral presentations. Key studies focus on BRUKINSA® (zanubrutinib), sonrotoclax, and BGB-16673. BRUKINSA, in combination with venetoclax, showed strong efficacy and favorable safety in high-risk CLL/SLL patients.
Sonrotoclax demonstrated promising safety and efficacy as a monotherapy and in combination therapies, particularly with BRUKINSA. Also, BGB-16673, a BTK degrader, showed encouraging results in BTK inhibitor-resistant diseases.
These findings underscore BeiGene's commitment to advancing treatment options for B-cell malignancies and other hematological conditions.
- BRUKINSA and venetoclax combination showed strong efficacy and favorable safety in high-risk CLL/SLL patients.
- Sonrotoclax demonstrated promising safety and efficacy as both monotherapy and in combination with other treatments.
- BGB-16673 showed encouraging efficacy and tolerability, particularly in BTK inhibitor-resistant diseases.
- BRUKINSA's adverse event management was cost-saving and associated with quality of life benefits compared to acalabrutinib.
- Multiple presentations highlighted the real-world effectiveness and patient outcomes for BRUKINSA.
- High frequency of new or new class anti-hypertensive medications needed for patients in the ibrutinib arm compared to the BRUKINSA arm in the ALPINE trial.
- Potential competitive pressure from other BTK inhibitors and treatments for CLL/SLL and other B-cell malignancies.
- Ongoing and future phase trials may reveal adverse safety profiles or less-than-expected efficacy.
Insights
The recent announcements by BeiGene at the European Hematology Association 2024 Congress offer substantial information that warrants attention from investors. The clinical data shared, particularly regarding BRUKINSA® and sonrotoclax, indicate strong efficacy and favorable safety profiles, which are important indicators for future financial performance. For example, the combination of BRUKINSA and venetoclax in high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) shows promising results. This can potentially lead to expanded market approval and increased revenue. Additionally, the adverse event-based economic analysis comparing BRUKINSA with acalabrutinib highlights cost-saving benefits, which could attract healthcare providers and insurers.
In terms of financial implications, the success of these clinical trials could bolster BeiGene's market position against competitors and potentially drive higher sales. It also suggests the likelihood of BeiGene securing more partnerships and collaborations, further enhancing their financial outlook. However, investors should be cautious about the inherent risks in drug development, including the potential for unexpected adverse events in larger, real-world populations.
The clinical data presented by BeiGene at EHA2024 are significant from a medical perspective. The novel BCL2 inhibitor, sonrotoclax, demonstrates deep and durable responses both as monotherapy and in combination with BRUKINSA. This suggests an effective treatment strategy for patients with relapsed/refractory blood cancers, potentially addressing unmet medical needs. The Phase 1/2 results for the BTK degrader BGB-16673 are also noteworthy, particularly for patients resistant to current BTK inhibitors. This could represent a major advancement in treating BTK inhibitor-resistant diseases.
For patients, the emphasis on safety and efficacy is reassuring. The data indicate that these new treatments could improve quality of life and extend survival rates. The tolerable safety profiles are particularly important, as they can significantly influence patient adherence and overall treatment success.
The data released by BeiGene at the EHA2024 Congress highlight the company's robust pipeline and strategic focus on hematology. The positive outcomes from various clinical trials, including those for BRUKINSA and sonrotoclax, underscore BeiGene's potential to capture a larger share of the hematology market. The differentiation of BRUKINSA among BTK inhibitors through economic and quality of life benefits is a strategic advantage, likely to enhance its competitive position.
From a market perspective, these developments could significantly boost BeiGene's valuation by strengthening its product portfolio. The success of these therapies in clinical trials can lead to increased market penetration and set the stage for future growth. This aligns with current industry trends where personalized and combination therapies are becoming the norm in treating hematological malignancies. However, market risks include potential competition from other emerging therapies and the need for continuous innovation.
Study evaluating BRUKINSA® in combination with venetoclax in high-risk, treatment-naïve CLL/SLL patients to be shared as oral presentation
BCL2 inhibitor sonrotoclax subject of multiple presentations highlighting promising safety and efficacy as monotherapy and in combinations, including with backbone therapy BRUKINSA
Phase 1/2 results for BTK degrader BGB-16673 showcasing encouraging efficacy and tolerability, including in BTK inhibitor resistant disease
“As part of our dedication to bringing high-quality therapies to patients around the world, our presentations at EHA2024 underscore our continued commitment to expanding our hematology portfolio and our efforts to build on the success of BRUKINSA’s unique clinical profile across multiple B-cell malignancies,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “The data highlight the potential of our differentiated investigational BCL2 inhibitor, sonrotoclax, as a monotherapy and in combination regimens, and the promise of BTK degradation to address the unmet needs of patients facing certain blood cancers.”
New Data Expand Evidence Base for BRUKINSA (zanubrutinib)
- Oral presentation of new data from an arm of the SEQUOIA study in patients with high-risk treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation treated with BRUKINSA and venetoclax, demonstrating strong efficacy and favorable safety (Abstract S160)
- Oral presentation sharing the results of an adverse event (AE) based economic analysis comparing BRUKINSA with acalabrutinib; in terms of AE management, BRUKINSA was cost-saving and associated with quality of life benefits compared to acalabrutinib (Abstract S333)
- Presentation of a post hoc analysis evaluating the risk of developing hypertension among ALPINE trial participants with relapsed or refractory (R/R) CLL/SLL, which demonstrated patients in the ibrutinib arm initiated new and/or a new class of anti-hypertensive medications more frequently than patients in the BRUKINSA arm (Abstract P1836)
- Results of an intra-patient comparative analysis from ROSEWOOD study of BRUKINSA plus obinutuzumab in patients with R/R follicular lymphoma (FL), supporting the efficacy benefit of the combination in this patient population (Abstract P1143)
- Multiple additional presentations featuring patient-reported outcomes and real-world differentiation of BRUKINSA among BTK inhibitors
Emerging Data Demonstrate Hematology Pipeline Strengths
- Oral presentation of a Phase 1 study of BeiGene’s novel BCL2 inhibitor sonrotoclax (BGB-11417) in combination with BRUKINSA, demonstrating deep and durable responses with a tolerable safety profile in patients with R/R CLL/SLL; the combination of sonrotoclax with backbone therapy BRUKINSA is being evaluated in the randomized Phase 3 CELESTIAL study (NCT06073821) in patients with TN CLL (Abstract S156)
- Poster presentation of Phase 1a/1b open-label dose escalation and expansion study of sonrotoclax in combination with BRUKINSA in R/R mantle cell lymphoma (MCL), showing the combination was generally well tolerated and demonstrated promising efficacy, including high rate of deep and durable responses (Abstract P1112)
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Additional presentations highlighting Phase 1 results for sonrotoclax, demonstrating encouraging response rates, durable responses and manageable safety profiles spanning multiple indications across B-cell and myeloid malignancies, including:
- As monotherapy in R/R Waldenström's macroglobulinemia (Abstract P1110)
- In combination with azacitidine in both TN and R/R acute myeloid leukemia (Abstracts P538 and P562)
- In combination with dexamethasone in R/R multiple myeloma harboring t(11;14) (Abstract P898)
- Oral presentation of data from the ongoing, first-in-human Phase 1/2 study of BeiGene’s Bruton tyrosine kinase (BTK) degrader BGB-16673, highlighting tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL (NCT05006716); BGB-16673, which induces BTK degradation, is the first investigational drug from BeiGene’s chimeric degradation activation compound (CDAC) platform (Abstract S157)
- Additional data from the Phase 1/2 study of BTK CDAC BGB-16673, demonstrating a tolerable safety profile and preliminary efficacy in heavily pretreated patients with different types of non-Hodgkin lymphoma, including those with BTKi-resistant disease (Abstract P1119)
BeiGene Presentations During EHA2024
Abstract Title |
Abstract # |
Presentation Type |
Presenting Author |
BTK CDAC (investigational compound) |
|||
Preliminary efficacy and safety of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients with relapsed or refractory (R/R) CLL/SLL: Results from the phase 1 BGB-16673-101 study |
S157 |
Oral |
R. Parrondo |
Preliminary efficacy and safety of the Bruton tyrosine kinase (BTK) degrader BGB-16673 in patients with relapsed or refractory (R/R) indolent NHL: Results from the phase 1 BGB-16673-101 study |
P1119 |
Poster |
C. Cheah |
Sonrotoclax (investigational compound) |
|||
Results from the phase 1 study of the novel BCL2 inhibitor sonrotoclax (sonro) in combination with zanubrutinib (zanu) for relapsed/refractory (R/R) CLL/SLL show deep and durable responses |
S156 |
Oral |
S. Opat |
Combination treatment with novel BCL-2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib induces high rate of complete remission for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) |
P1112 |
Poster |
C. Tam |
Safety and efficacy results of a phase 1 study of the novel BCL2 inhibitor sonrotoclax (BGB-11417) for relapsed/refractory Waldenström's macroglobulinemia |
P1110 |
Poster |
C Cheah |
Preliminary safety and antileukemic activity of sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in treatment-naive patients with acute myeloid leukemia |
P538 |
Poster |
S. Tan |
Preliminary safety and antileukemic activity of sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in patients with relapsed/refractory acute myeloid leukemia |
P562 |
Poster |
P. Montesinos |
Sonrotoclax plus dexamethasone is tolerable and demonstrates antimyeloma activity in patients with relapsed/refractory (R/R) multiple myeloma harboring t(11;14) |
P898 |
Poster |
B. Dhakal |
BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia |
PB2954 |
Online abstract |
J. Matous |
CELESTIAL-TN CLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive (TN) CLL |
PB2540 |
Online abstract |
P. Patten |
Zanubrutinib |
|||
Combination of zanubrutinib + venetoclax for treatment-naive (TN) CLL/SLL with del(17p) and/or TP53: Preliminary results from SEQUOIA arm D |
S160 |
Oral |
P. Ghia |
Intra-patient comparative analysis of zanubrutinib plus obinutuzumab efficacy in relapsed/refractory follicular lymphoma using the Growth Modulation Index |
P1143 |
Poster |
K. Bouabdallah |
Risk of hypertension in patients with CLL/SLL who participated in ALPINE: A post hoc analysis |
P1836 |
ePoster |
W. White |
Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia patients treated with Bruton tyrosine kinase inhibitors: A real-world study using the Symphony Health Solutions database |
P1847 |
ePoster |
W. White |
Zanubrutinib vs. acalabrutinib in B-cell malignancies: an adverse event-based economic analysis |
S333 |
Oral |
T. Munir |
Efficacy of zanubrutinib versus acalabrutinib in the treatment of relapsed or refractory chronic lymphocytic leukemia (R/R CLL): A matching-adjusted indirect comparison (MAIC) |
P700 |
Poster |
M. Shadman |
Efficacy and safety of zanubrutinib vs. venetoclax+ibrutinib in the treatment-naïve (TN) chronic lymphocytic leukemia (CLL): A matching-adjusted indirect comparison (MAIC) |
P702 |
Poster |
T. Munir |
Matching-adjusted indirect comparison (MAIC) of zanubrutinib versus real-world chemoimmunotherapy (CIT) or chemotherapy (chemo) in relapsed/refractory marginal zone lymphoma (R/R MZL) |
P1123 |
Poster |
R. Walewska |
Indirect comparison of efficacy of zanubrutinib versus acalabrutinib in the treatment of relapsed/refractory mantle cell lymphoma |
P2058 |
ePoster |
B. Shah |
Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: A network meta-analysis |
P701 |
Poster |
M. Shadman |
Zanubrutinib vs other Bruton’s tyrosine kinase inhibitors in relapsed/refractory chronic lymphocytic leukemia: A multilevel network meta-regression |
P698 |
Poster |
M. Shadman |
Patient-reported outcome (PRO)–based recurrent symptomatic deterioration predicts disease progression: Results from the ALPINE trial |
P1834 |
ePoster |
J. Brown |
Real-world comparative effectiveness of covalent Bruton tyrosine kinase inhibitors (cBTKi) among patients with relapsed/refractory mantle cell lymphoma (R/R MCL) |
P1139 |
Poster |
T. Phillips |
Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL |
P697 |
Poster |
J. Pinilla-Ibarz |
Real-world Bruton tyrosine kinase inhibitor treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices |
P685 |
Poster |
J. Hou |
Real-world evaluation of treatment pattern, time to next treatment, healthcare resource utilization, and cost of care in follicular lymphoma |
P1124 |
Poster |
S. Gaballa |
Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma |
P2045 |
ePoster |
B. Shah |
Recent patterns of care with BTK inhibitors and distribution of social determinants of health among patients with CLL/SLL in the US community setting |
PB2546 |
Online abstract |
D. Andorsky |
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.
About Sonrotoclax (BGB-11417)
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 BGB-16673
BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC) designed to induce degradation of wildtype and multiple mutant forms of BTK, including those that commonly confer resistance to BTK inhibitors in patients who experience progressive disease.
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.
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), 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 BeiGene’s continued commitment to expanding its hematology portfolio; the promise of BTK degradation to address unmet needs of blood cancer patients; 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
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Investor Contact:
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+1 857-302-5663
ir@beigene.com
Media Contact:
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Source: BeiGene, Ltd.
FAQ
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What is sonrotoclax and how effective is it?
What new data did BeiGene present about BGB-16673 at EHA2024?
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