BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL
BeiGene announced new analyses for BRUKINSA® (zanubrutinib) at the ASCO Annual Meeting 2024. The data underline BRUKINSA's efficacy and safety in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) compared to other BTK inhibitors (BTKis).
A network meta-analysis highlighted BRUKINSA's superior progression-free survival (PFS) over acalabrutinib in high-risk relapsed/refractory CLL patients. Additional findings indicated a trend towards better overall survival (OS) and overall response (ORR) rates.
A retrospective analysis from Kaiser Permanente revealed that BRUKINSA is well-tolerated, with lower treatment-limiting adverse events, particularly cardiac-related, compared to ibrutinib. A post-hoc analysis of the ALPINE trial showed patients on BRUKINSA had less frequent initiation of new antihypertensive medications.
Overall, BRUKINSA demonstrates a favorable clinical profile, offering significant insights for oncologists in treatment decision-making for CLL and SLL patients.
- BRUKINSA shows statistically significant improvements in PFS over acalabrutinib in high-risk R/R CLL patients.
- Trend towards better OS and ORR rates with BRUKINSA compared to other BTKis.
- Lower treatment-limiting adverse events (TLAEs) with BRUKINSA compared to ibrutinib.
- No treatment-related deaths reported in patients switching to BRUKINSA from ibrutinib.
- Less frequent initiation of new antihypertensive medications in patients treated with BRUKINSA vs. ibrutinib.
- Network meta-analyses do not establish superior efficacy or safety, by the context of analysis and available clinical trial data.
- Higher cardiac TLAE and non-TLAE rates with ibrutinib compared to BRUKINSA.
Insights
BRUKINSA’s new data from the ASCO conference offers important insights into its efficacy and safety for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The network meta-analysis reveals statistically significant improvement in progression-free survival (PFS) for BRUKINSA over acalabrutinib and other BTK inhibitors, such as ibrutinib. This suggests BRUKINSA may offer superior disease control for patients with high-risk relapsed/refractory CLL. PFS is a critical measure in oncology as it indicates the length of time during and after treatment that a patient lives with the disease without it worsening. The favorable PFS and observed trends towards improved overall survival (OS) and response rates are promising, although it is necessary to consider that network meta-analyses have inherent limitations due to combining data from different trials.
Moreover, the analysis of real-world data from the Kaiser Permanente database indicating comparable treatment-emergent adverse events (TEAEs) and lower treatment-limiting adverse events (TLAEs) for BRUKINSA provides further validation of its safety profile. Notably, the lower cardiac toxicity observed with BRUKINSA compared to ibrutinib is a significant finding, as cardiac issues can substantially impact a patient’s quality of life.
Another critical aspect is the reduction in the initiation of antihypertensive medications in the BRUKINSA arm compared to ibrutinib. This suggests a lower likelihood of treatment-induced hypertension, a common side effect of BTK inhibitors, which can be a important consideration for long-term patient management.
Overall, the data reinforce BRUKINSA as a potentially superior option for certain patient populations, albeit with the caveat that head-to-head randomized trials would provide stronger evidence.
The new findings presented about BRUKINSA at the ASCO Annual Meeting have several implications for investors. From a financial perspective, the positive clinical data demonstrating superior progression-free survival (PFS) and a trend towards improved overall survival could translate into increased adoption of BRUKINSA by oncologists. This can potentially drive higher revenue for BeiGene, considering the competitive landscape of BTK inhibitors in treating CLL and SLL. Positive patient outcomes often lead to higher demand and extended market share, especially in markets where payer decisions heavily weigh clinical efficacy and safety profiles.
The real-world data from the Kaiser Permanente analysis further corroborates BRUKINSA's safety and efficacy, particularly in patients switching from ibrutinib. This may encourage current users of other BTK inhibitors to switch to BRUKINSA, again bolstering its market position.
However, it is essential to recognize the limitations of network meta-analyses, as they are not as robust as direct head-to-head clinical trials. Regulatory bodies and payers may still require more conclusive data before making coverage decisions or recommendations. Therefore, investors should cautiously monitor further developments and additional clinical data that could solidify BRUKINSA’s standing in the treatment landscape.
Given the current data, the stock might experience short-term gains as the market reacts to these promising results. For long-term investments, keeping an eye on subsequent head-to-head trials and real-world usage patterns will be crucial.
BRUKINSA’s latest results presented at ASCO provide a strong competitive edge in the BTK inhibitor market. The differentiated clinical profile, particularly in terms of progression-free survival (PFS), positions BRUKINSA favorably against competitors like acalabrutinib and ibrutinib. This is particularly relevant in the context of the increasing focus on personalized medicine, where efficacy and safety profiles play a pivotal role in treatment decisions.
The finding that BRUKINSA is effective and generally well-tolerated by patients switching from ibrutinib is noteworthy. It indicates potential for capturing market share from existing BTK inhibitors, as clinicians may prefer a treatment with fewer cardiac side effects and lower incidences of treatment-limiting adverse events (TLAEs). Additionally, the reduced need for initiating antihypertensive medications with BRUKINSA could be a significant selling point in discussions with healthcare providers and payers.
The oncology market is highly competitive and ongoing innovation is critical for maintaining and growing market share. BeiGene’s presentation at ASCO underscores their commitment to continuous improvement and providing substantial clinical evidence. Investors and stakeholders should view these developments as positive indicators of BRUKINSA’s trajectory in the market, although it is essential to stay updated with further clinical outcomes and regulatory feedback.
New network meta-analysis demonstrates favorable progression-free survival for patients treated with BRUKINSA vs other BTKi's
Analysis of Kaiser Permanente database shows BRUKINSA effective and generally well tolerated, including in patients switching to BRUKINSA from ibrutinib
ALPINE post hoc analysis shows less frequent initiation of new antihypertensives or a new class of antihypertensives in patients treated with BRUKINSA vs. ibrutinib
“At this year’s ASCO, multiple presentations continue to add to our extensive body of evidence demonstrating BRUKINSA’s uniquely differentiated clinical profile,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “These new analyses, which highlight improved PFS and response rates and a low usage of antihypertensive medicines, provide valuable insights for oncologists to consider when making treatment decisions for their patients with CLL and SLL.”
BRUKINSA Survival and Response Rates for CLL vs. Acalabrutinib and other BTKis in a Network Meta-Analysis
A network meta-analysis evaluated the relative efficacy of available treatments for patients with high-risk relapsed/refractory (R/R) CLL using data from three randomized controlled clinical trials: ALPINE, ELEVATE-RR and ASCEND. The analysis found a statistically significant improvement in PFS for BRUKINSA over acalabrutinib in high-risk patients and a trend toward improvement in overall survival (OS), overall response (ORR) and complete response (CR). BRUKINSA led to statistically significant improvements in PFS, as well as a trend toward improvement in OS, vs. ibrutinib and bendamustine + rituximab/idelalisib + rituximab (BR/IR).
“Given the lack of head-to-head trials comparing BTK inhibitors in high-risk R/R CLL patients, we undertook a network meta-analysis to estimate the relative efficacy of available treatments,” said Mazyar Shadman, M.D. M.P.H, Associate Professor and Innovators Network Endowed Chair, Assistant Medical Director, Cellular Immunotherapy, Fred Hutch Cancer Center and University of
Network meta-analyses are intended to be hypothesis-generating, and do not establish superior efficacy or safety of one drug over another. Results should be viewed in the context of analysis limitations and available randomized clinical trial data.
- This poster will be presented Monday, June 3, from 9 a.m. – noon CT (Abstract #7048).
BRUKINSA Effective and Generally Well-Tolerated for Patients with CLL/SLL Regardless of Prior Ibrutinib Use
A retrospective analysis assessed treatment patterns, treatment-emergent adverse events (TEAEs), treatment-limiting adverse events (TLAEs) and treatment-related mortality among patients with CLL/SLL treated at Kaiser Permanente Northern California. Among 281 patients who received BRUKINSA, 190 switched from ibrutinib and 91 received only BRUKINSA, with a median follow up of 24.4 and 8.2 months, respectively. Similar TEAE rates were seen with both BTKi therapies, with lower TLAE rates with BRUKINSA. Cardiac TLAE and non-TLAE rates overall were higher with ibrutinib than BRUKINSA, and the rates decreased after switching to BRUKINSA. There were no reports of treatment-related deaths.
- This poster will be presented Monday, June 3, from 9 a.m. – noon CT (Abstract #11158).
ALPINE Post Hoc Analysis Shows Less Frequent Initiation of Anti-hypertensive Medications in Patients Treated with BRUKINSA vs. Ibrutinib
A post-hoc analysis of the ALPINE clinical trial data evaluated the risk of developing hypertension based on initiation of anti-hypertensive medications among patients with CLL/SLL treated with BRUKINSA vs. ibrutinib. The analysis found that initiation of new anti-hypertensives or a new class of anti-hypertensives occurred less frequently in the BRUKINSA arm vs. the ibrutinib arm. In addition, initiation of anti-hypertensives occurred sooner for patients treated with ibrutinib vs. BRUKINSA. Data from this analysis provide important insights when evaluating the overall safety profile of individual BTKi treatments.
- This abstract is available online (Abstract #e19016).
During the meeting, BeiGene will also sponsor a virtual panel discussion featuring perspectives from leading hematology/oncology experts as they discuss the BTKi treatment evolution, and the considerations healthcare providers and patients should weigh when choosing treatment for CLL. The panel, titled “Exploring the landscape of next-generation BTK inhibitors in blood cancers” will take place during the Endpoints at #ASCO24 event on June 4 at 12:35 – 1:05 p.m. ET (register here).
For additional information about BeiGene’s presence at the 2024 ASCO Annual Meeting, please visit our meeting hub in our newsroom.
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.
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.
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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 BRUKINSA’s differentiated clinical profile; the efficacy of zanubrutinib for patients with high-risk R/R CLL compared to other BTKi treatments; 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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Liza Heapes
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ir@beigene.com
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Source: BeiGene, Ltd.
FAQ
What is the significance of BRUKINSA's progression-free survival data presented at ASCO 2024?
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What were the findings of the ALPINE post-hoc analysis regarding antihypertensive medication use?
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