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Business Wire
a day ago
- Business
- Business Wire
BeOne Medicines Receives Positive CHMP Opinion for TEVIMBRA ® in Neoadjuvant/Adjuvant NSCLC Treatment
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA ® (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. This recommendation is based on the Phase 3 RATIONALE-315 study (NCT04379635). 'Patients with resectable, early-stage NSCLC face an urgent challenge – despite surgery and current therapies, recurrence rates remain alarmingly high,' said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at the Faculty of Medicine of Universidad Autonoma de Madrid in Spain. 'The significant clinical benefit observed in the RATIONALE-315 study has important implications for patients. If approved, perioperative tislelizumab will offer oncologists a powerful new option to improve outcomes and potentially alter the course of this difficult-to-treat disease.' RATIONALE-315 is a double-blind, placebo-controlled, multicenter, Phase 3 study that randomized 453 patients with resectable NSCLC 1:1 to receive either TEVIMBRA plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by TEVIMBRA as adjuvant treatment or placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. As previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024 1, the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses of the RATIONALE-315 study. Results include: Statistically significant and clinically meaningful improvement in MPR and pathological complete response (pCR) rates: 56.2% of NSCLC patients treated with TEVIMBRA in combination with chemotherapy before surgery achieved MPR compared to 15.0% of patients treated with chemotherapy in combination with placebo (difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001) 40.7% of patients on the TEVIMBRA-based regimen achieved pCR, compared to 5.7% of patients treated with chemotherapy in combination with placebo (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001) Statistically significant EFS (HR [95% CI], 0.56 [0.40–0.79]; 1-sided P=0.0003) and trend for overall survival (OS) (HR [95% CI], 0.62 [0.39–0.98]; 1-sided P=0.0193) benefits favoring TEVIMBRA in early data. Consistent safety profile of the TEVIMBRA arm with that of individual therapies, with 72.1% of patients in the TEVIMBRA arm (vs. 66.4% in the placebo arm) experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% of patients in the TEVIMBRA arm (vs. 8.0% in the placebo arm) experiencing serious TRAEs. There were no new safety signals identified with this regimen, and the most common Grade 3 or 4 TRAEs (≥ 10%) in the TEVIMBRA arm were decreased neutrophil count and decreased white blood cell count. No impact on the feasibility and completeness of surgery, a key concern around neoadjuvant treatment. Updated EFS and OS data from the pre-planned final analysis of RATIONALE-315 will be submitted for presentation at an upcoming medical conference. 'TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'As the foundational asset of our solid tumor portfolio, TEVIMBRA continues to demonstrate its strength and versatility across the continuum of care, bringing us closer to our goal of delivering more comprehensive and effective cancer treatment to more patients.' In lung cancer, TEVIMBRA is already approved in the EU for the first-line treatment of patients with squamous NSCLC, for the first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression, for the treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy, and as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It is also approved as a first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, and as a first-line treatment for patients with nasopharyngeal carcinoma (NPC). About NSCLC Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide. 2 In Europe, lung cancer is the third most frequent cancer with 484,306 new cases diagnosed in 2022. 3 NSCLC accounts for 80–90% of all lung cancers 4, of which resectable NSCLC patients at diagnosis represent around 25–30% 5. About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Important Safety Information The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency. This information is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its 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 BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom site.
Business Wire
10-07-2025
- Health
- Business Wire
European Commission Approves TEVIMBRA ® in Combination with Chemotherapy as a First-Line Treatment for Nasopharyngeal Carcinoma
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved TEVIMBRA ® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. Nasopharyngeal carcinoma is a rare cancer in which malignant cells form in the nasopharynx, the upper part of the throat located behind the nose. 1 'The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease,' said Prof. Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. 'Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care.' The approval in NPC is based on results of RATIONALE-309 (NCT03924986), a double-blind, placebo-controlled, multicenter, Phase 3 study, which randomized 263 treatment-naïve patients who received either TEVIMBRA in combination with gemcitabine plus cisplatin or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001), showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm. An updated analysis with an additional 12 months of follow-up showed efficacy results consistent with the interim analysis. Clinically meaningful and sustained improvement in overall survival (OS) was observed, with a median OS of 45.3 months for TEVIMBRA plus chemotherapy compared to 31.8 months for placebo plus chemotherapy. TEVIMBRA plus chemotherapy was generally well tolerated, and no new safety signals were identified. Pooled safety data included over 3,900 patients who received TEVIMBRA, either as monotherapy (n=1,952) or in combination with chemotherapy (n=1,950), at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 10%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and thrombocytopenia. 'Following our recent EU approval of TEVIMBRA for extensive-stage small cell lung cancer, this new authorization in nasopharyngeal carcinoma reflects strong momentum in broadening access to our immunotherapy across solid tumors,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.' TEVIMBRA was previously approved in the EU as a first-line treatment for eligible patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings. About Nasopharyngeal Cancer (NPC) Nasopharyngeal cancer, also known as nasopharyngeal carcinoma, is a type of head and neck cancer that starts in the nasopharynx, the upper throat passage that connects the nose to the lungs. 2 NPC, which can be categorized into different pathological subtypes (keratinizing squamous, non-keratinizing, and basaloid squamous) 3, is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging. 4 In 2020, NPC accounted for approximately 133,000 new cancer cases and 80,000 deaths per year globally and exhibits a unique geographical pattern, with its prevalence notably concentrated in Asia. 5 While the overall 5-year survival rate for NPC is approximately 63%, in advanced disease the survival rate decreases to 49%. 6 About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Important Safety Information The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency. This information is intended for a global audience. Product availability and approved indications vary by country. Please refer to local prescribing information for complete details. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 TEVIMBRA plus chemotherapy to significantly reduce the risk of disease progression or death for patients with recurrent or metastatic NPC; BeOne's ability to expand patient access to cancer treatments; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its 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 BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom. 1 National Cancer Institute at the National Institutes of Health. Nasopharyngeal Cancer Treatment (PDQ®)–Patient Version. 2 Cleveland Clinic. Nasopharynx. 3 American Cancer Society. What Is Nasopharyngeal Cancer? 4 Wei, X., et al. (2024) Nasopharyngeal cancer risk assessment by country or region worldwide from 1990 to 2019. BMC Public Health, 24, 1931. 5 Yang, Y., et al. (2023) Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell, 41(7): 1061–1072. 6 American Cancer Society. Survival Rates for Nasopharyngeal Cancer.
Business Upturn
26-06-2025
- Business
- Business Upturn
BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day
San Carlos, Calif., United States: BRUKINSA, sonrotoclax, and BTK CDAC data, including combinations, are designed to comprehensively address unmet needs across CLL patient populations Promising new data from pipeline assets in breast, lung, and GI cancer franchises, including CDK4 inhibitor, B7-H4 ADC, and novel PRMT5 inhibitor, will be featured Pipeline is at an exciting inflection point with 20 near-term milestones in the next 18 months In a significant showcase for investors, BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will announce major advancements to its industry-leading oncology pipeline during today's investor R&D Day. The event comes at a pivotal moment for the Company, which has more than 40 clinical and commercial stage assets in development, a signal of both scale and ambition. 'At BeOne, our mission is simple yet bold: to create the world's first next-generation oncology company,' said John V. Oyler, Co-Founder, Chairman, and CEO. 'What we will unveil demonstrates our progress towards this goal today, and the promise for tomorrow. From our innovative discovery engine to one of the broadest pipelines in oncology, we are well-positioned to bring transformative medicines to patients worldwide—and to do so with speed, quality, and purpose.' BeOne's integrated, end-to-end R&D model is engineered for efficiency without compromise. The Company's differentiated approach—combining in-house discovery targeting unmet patient needs, parallel early-stage exploration at low incremental cost, and rapid proof-of-concept generation—enables swift progression from bench to clinic. Our in-house manufacturing around the world, including our flagship facility in Hopewell, NJ, means we have a sustainable business model, purpose built with competitive advantages. This rigorous model has fueled a pipeline of more than 40 clinical and commercial-stage assets, making it one of the most productive in the industry. To complement this research engine, BeOne has built a robust global clinical development platform, with more than 170 trials conducted across 40 countries and more than 25,000 patients enrolled to date. In hematologic cancers, the Company's program is driven by its wholly-owned assets including BRUKINSA® (zanubrutinib), a second-generation covalent BTK inhibitor and the backbone of the hematology franchise, sonrotoclax, a potential best-in-class next-generation BCL2 inhibitor, and BGB-16673, a BTK CDAC. New clinical data from CaDAnCe-101 highlight the promise of BGB-16673, a potential first-in-class BTK degrader, for patients with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL). Meanwhile, early data show the combination of sonrotoclax and BRUKINSA has demonstrated compelling efficacy and the potential to offer a best-in-class fixed-duration treatment in CLL, setting the stage for a possible new standard of care. In solid tumors, the Company is advancing multiple targeted modalities beyond its foundational PD-1 inhibitor TEVIMBRA® (tislelizumab-jsgr), including CDK4 inhibitor BGB-43395, which has shown clear pharmacodynamic activity and is expected to enter registration-enabling studies for the treatment of breast cancer within the next six to 12 months. Promising new data for the B7-H4 ADC (BG-C9074) point to a potential first-in-class therapeutic option for patients with B7-H4 expressing tumors, including those without selection criteria. Additionally, early data from the novel PRMT5 inhibitor suggest a favorable safety profile and promising efficacy, supporting its potential for differentiation in the competitive lung cancer field. 'Our R&D team is running at full speed,' said Lai Wang, Ph.D., Global Head of R&D. 'With more than 1,200 scientists and more than 3,700 clinical development and medical affairs colleagues dedicated to pushing the boundaries of oncology, we have built the infrastructure, mindset, and capabilities to deliver sustained innovation. The volume of clinical milestones we anticipate over the next few years is extraordinary, and our agility in moving from idea to execution sets us apart.' Speakers at today's event include BeOne's executive leadership team, senior R&D leaders, and distinguished key opinion leaders, offering a multi-faceted view of the Company's scientific strategy and execution momentum. The live webcast begins at 8:30 a.m. U.S. Eastern Time and is available on the investor relations section of BeOne's website, where an archived version will also be accessible. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, 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 the future success of BeOne's pipeline assets; BeOne's ability to bring transformative medicines to patients worldwide with both speed and quality; the productivity of BeOne's pipeline; the ability of BeOne's assets to provide a new standard of care; the timing for BGB-43395 to enter registration-enabling studies; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit ourNewsroom. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Business Wire
11-06-2025
- Business
- Business Wire
U.S. FDA Approves Tablet Formulation of BeOne's BRUKINSA
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA ® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. 1 BRUKINSA tablets have the same efficacy and safety as BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies of healthy adults designed to establish bioequivalence. BRUKINSA is the only BTK inhibitor to offer the flexibility of once or twice daily dosing, with the ability to tailor the schedule to patient needs. It also continues to be the only BTK inhibitor with recommended dosing for severe hepatic impairment. 'BRUKINSA's leadership in the U.S. underscores the trust physicians and patients have placed in its differentiated clinical profile,' said Matt Shaulis, General Manager of North America, BeOne. 'With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients facing certain B-cell cancers.' The recommended dose of BRUKINSA remains at 320 mg daily. The new BRUKINSA tablets are 160 mg each, allowing patients to take two tablets daily rather than four of the current 80 mg capsules. Additionally, BRUKINSA tablets are smaller than the capsules and have a film coating, making them easier to swallow. The BRUKINSA tablets will replace capsules starting in October 2025. The European Medicines Agency is currently reviewing a Type II variation marketing authorization application (MAA) for the new tablet formulation of BRUKINSA in all currently approved indications, with approval expected later this year. About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, 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. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets in at least one indication, and more than 200,000 patients have been treated globally. 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. 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 (≥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 BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 physicians and patients trust in BRUKINSA; whether the new tablet formulation for BRUKINSA will result in better patient experience; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our News & Media site.
Business Wire
02-06-2025
- Business
- Business Wire
BeOne Medicines Unveils Promising Clinical Data for Two Novel Breast Cancer Therapies at ASCO 2025
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced new clinical data from its emerging breast cancer pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Poster presentations feature preliminary results of the dose escalation studies of two investigational molecules: BG-C9074, a novel B7-H4-targeting antibody-drug conjugate (ADC) in patients with advanced solid tumors, including breast cancer, and BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), in HR+/HER2- breast cancer patients with prior CDK4/6i exposure. 'Presenting the first clinical data for two novel breast cancer candidates at ASCO 2025 marks a pivotal moment for BeOne,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'These early results highlight the strong potential of our B7-H4-targeting ADC and CDK2 inhibitor to address critical gaps in breast cancer treatment. Alongside our advancing CDK4 inhibitor, they represent just the beginning of a pipeline built on targeted, biology-driven innovation. As we debut our new identity as BeOne, this milestone reflects the momentum behind our science and our commitment to delivering impactful therapies to cancer patients worldwide.' BeOne is advancing a robust pipeline of differentiated investigational medicines for breast cancer that may both effectively combat the disease and potentially improve quality of life for patients receiving treatment. BG-C9074, a B7-H4-targeting ADC (Abstract #3033) BeOne presented initial results of the ongoing first-in-human, Phase 1a dose escalation study of BG-C9074 monotherapy in 78 patients with advanced solid tumors, of which more than a quarter were breast cancer patients. BG-C9074, an investigational topoisomerase I inhibitor ADC that targets the B7-H4 protein, which is broadly expressed in breast and gynecologic cancers, is designed with an innovative drug linker to deliver a potent cancer-killing drug directly to the cancer cells. With limited follow-up among the 56 efficacy-evaluable patients, preliminary clinical responses were observed at multiple dose levels across various tumor types without selection for B7-H4 expression in these heavily pretreated patients. Confirmed overall response rate (ORR) was 16.1% (9/56; 95% CI: 7.6%–28.3%), with 9 confirmed partial responses; unconfirmed ORR was 25.0% (14/56; 14.4%-38.4%) (n=14 partial responses). Confirmed disease control rate (DCR) was 73.2% (59.7%-84.2%) and confirmed clinical benefit rate (CBR) was 17.9% (8.9%-30.4%). Pharmacokinetics (PK) were observed to be approximately dose-proportional across dose levels. BG-C9074 showed a manageable safety and tolerability profile in patients with B7-H4 advanced solid tumors, including breast cancer. There were 5 dose-limiting toxicities (DLTs) reported among 3 dose levels, all related to treatment: grade 3 fatigue (n=1); grade 3 febrile neutropenia (n=2); and grade 4 platelet count decreased (n=2). The most common treatment-emergent adverse events (TEAEs) were nausea, fatigue, and neutropenia*. The most common grade ≥3 TEAEs were neutropenia and thrombocytopenia†. There were no TEAEs leading to treatment discontinuation or death. These data support the continued development of BG-C9074 in patients with advanced solid tumors. (NCT06233942) BG-68501, a CDK2 inhibitor (Abstract# 3115) Dose-escalation data from the first-in-human, Phase 1a study of a novel CDK2 inhibitor, BG-68501, were presented as a poster today. BG-68501 is designed to address elevated CDK2 activity as well as cyclin E1-driven upregulation, two key resistance mechanisms that often limit the effectiveness of CDK4/6 inhibitors in treating HR+/HER2- breast cancer. CDK inhibitors target checkpoint proteins that control cell division to stop the growth of cancer cells. A total of 57 enrolled patients with advanced solid tumors, including 19 patients with HR+/HER2- metastatic breast cancer, received BG-68501 as monotherapy or in combination with fulvestrant in escalating dose cohorts (all received prior CDK4/6i). Of the 37 efficacy-evaluable patients (all with monotherapy), unconfirmed overall response rate (ORR) was 5.4% (2/37; 95% CI: 0.7%–18.2%). Two extensively pretreated patients (5.4%) experienced unconfirmed partial response (PR), 15 patients (40.5%) had stable disease (SD), 15 patients (40.5%) had progressive disease (PD), and 5 patients (13.5%) were not evaluable/not assessed. Of the 2 patients with PR, both were breast cancer patients, and one was ongoing with treatment at the time of data cutoff, while the other had discontinued treatment. Unconfirmed clinical benefit rate (CBR) was 8.1% (3/37; 95% CI: 1.7%-21.9%) and unconfirmed disease control rate (DCR) was 45.9% (17/37; 95% CI: 29.5%-63.1%). BG-68501 demonstrated a linear PK profile consistent with preclinical data and signs of pharmacodynamic responses. BG-68501 demonstrated a manageable safety and tolerability profile, with no DLTs observed to date during dose escalation. The most common TEAEs were vomiting, nausea, and fatigue, and TEAEs leading to treatment discontinuation occurred in 4 patients (7%) across all dose levels. There were no TEAEs leading to death. The data support continued development of BG-68501 as a next-line option for tumors with CDK2 dependency. (NCT06257264) For additional information about our presence at the 2025 ASCO Annual Meeting, please visit our meeting hub: BeOne will host an investor R&D Day on June 26 at 8:30 am ET covering its deep and broad global innovation pipeline and platforms, as well as the Company's vision, differentiated capabilities, and value creation drivers. A live webcast will be accessible from the investors section of BeOne's website at or An archived replay will be available for 90 days following the event. About Our Breast Cancer Pipeline BeOne is advancing a robust portfolio of investigational medicines for breast cancer, including three molecules in clinical development – two cyclin-dependent kinase (CDK) inhibitors, BGB-43395, a CDK4 inhibitor, and BG-68501, a CDK2 inhibitor, and an antibody-drug conjugate (ADC), BG-C9074. BeOne also plans to evaluate the potential of BCL2 inhibition in breast cancer, with next-generation BCL2 inhibitor, BGB-21447, expected to begin clinical testing in solid tumor indications soon. Multispecific antibodies and targeted protein degraders with potential applications in breast cancer are among the preclinical assets being developed. About Breast Cancer Breast cancer accounts for close to one in four cancer cases and one in six cancer deaths in women worldwide. 1 Globally, breast cancer is the second most common cancer and the fourth highest cause of cancer mortality as well as the leading cause of cancer death in women. 1 More than 2.3 million patients were diagnosed with breast cancer in 2022, and over 666,000 deaths were reported globally. 1 Approximately two-thirds of breast cancer cases are the HR+/HER2- subtype. 2 About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 potential of BeOne's B7-H4-targeting ADC and CDK2 inhibitor to address critical gaps in breast cancer treatment; the ability of BeOne to deliver impactful therapies to cancer patients worldwide; the ability of BeOne's pipeline to effectively combat breast cancer and improve quality of life for patients; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne'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; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne'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 BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our News & Media site. *Neutropenia was defined by a custom MedDRA basket with neutropenia and neutrophil count decrease preferred terms. †Thrombocytopenia was defined by a custom MedDRA basket with thrombocytopenia and platelet count decreased preferred terms. 1 Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. April 4, 2024. 2 National Cancer Institute, SEER. Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed November 11, 2024.
