Sonrotoclax

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 SAN MATEO, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data from its hematology portfolio and pipeline at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June 13-16, 2024. BeiGene has 28 abstracts accepted at EHA2024, with four scheduled for oral presentations. “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 pro 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 pro 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) 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 pro 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. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) 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 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. 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 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. 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 (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. 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 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. 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 (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). 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 U.S. Prescribing Information including U.S. Patient Information. 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 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 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. To access BeiGene media resources, please visit our News & Media site. View source version on businesswire.com: Contacts Investor Contact: Liza Heapes +1 857-302-5663 ir@beigene.com Source: BeiGene, Ltd. View this news release online at:

BeiGene, a leading pharmaceutical company, has achieved remarkable success in the first quarter of 2024. With total revenue surpassing 5.3 billion yuan, the company has witnessed substantial growth and made significant strides in penetrating global markets. BeiGene recently released its Q1 2024 financial report, revealing a total revenue of 5.359 billion yuan, representing a remarkable year-on-year growth of 74.8%. The global product revenue reached an impressive 5.325 billion yuan, marking a substantial increase of 89.6%. Notably, two core products, Baiyueze® and Baizean®, played a pivotal role in driving these exceptional results, contributing nearly 4.5 billion yuan in sales. Baiyueze®, the first "billion-dollar molecule" in China, witnessed an outstanding sales growth of 140.2% in Q1 2024, generating revenue of 3.476 billion yuan. This remarkable achievement can be attributed to its dominance in the treatment of chronic lymphocytic leukemia (CLL), where it has captured a significant market share. In the United States alone, Baiyueze® accounted for 70% of the sales revenue, amounting to 2.496 billion yuan, reflecting a substantial year-on-year growth of 162.7%. Additionally, the European market experienced a significant surge in Baiyueze® sales, with a remarkable growth rate of 256.8%, further expanding the market share. In the domestic market, Baiyueze® achieved sales revenue of 413 million yuan, representing a growth rate of 25.5%. Baizean®, another core self-developed product of BeiGene, also showcased exceptional performance in Q1 2024, with total sales revenue of 1.044 billion yuan, reflecting a growth rate of 32.8%. Particularly in the field of PD-1 inhibitors in China, Baizean® has established a leading market share. To date, Baizean® has obtained regulatory approvals for 12 indications in the domestic market. Furthermore, the global expansion of Baizean® has been accelerating, with regulatory approvals secured in various regions, including the European Union, the United Kingdom, and the United States. In the European market, Baizean® received approval for the treatment of three indications of non-small cell lung cancer, following its initial approval for esophageal squamous cell carcinoma (ESCC). In the United States, Baizean® obtained its first indication approval for the second-line treatment of ESCC and is expected to be launched in the second half of 2024. The inclusion of Baizean® as a preferred treatment option in the National Comprehensive Cancer Network (NCCN) guidelines for ESCC further validates its high-quality research data and excellent efficacy. With the remarkable success of these two core products, BeiGene is accelerating the development of its pipeline and has established a comprehensive, diverse, and rich portfolio of investigational drugs. In the field of solid tumors, BeiGene is actively advancing differentiated projects, with several new molecular entities entering the clinical stage in 2024. These include pan-KRAS inhibitors, MTA synergistic PRMT5 inhibitors, EGFR-CDAC, CEA-ADC, and FGFR2b-ADC, covering indications such as lung cancer, breast cancer, and gastrointestinal cancer. In the field of hematology, BeiGene is driving the research of BCL-2 inhibitor sonrotoclax, with four registration clinical trials currently underway, including a global Phase 3 trial in combination with Baiyueze® for the first-line treatment of CLL. Furthermore, BTK CDAC has initiated two expansion cohort studies and is expected to commence a Phase 3 clinical trial for R/R CLL by the end of 2024. BeiGene's outstanding performance in Q1 2024, with revenue exceeding 5.3 billion yuan, highlights the company's rapid expansion and increasing global presence. The impressive sales growth of core products, Baiyueze® and Baizean®, demonstrates the company's commitment to innovation and its ability to capture significant market share. With a robust pipeline of investigational drugs, BeiGene is poised to further enhance its operational efficiency and achieve more breakthroughs in the years to come.