Acalabrutinib

BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL

Retrieved on: 
fredag, maj 24, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, ASCEND, Chronic lymphocytic leukemia, Risk, Network, Clinical trial, University, Rituximab, PFS, Meta-analysis, Safety, Acalabrutinib, University of Washington, CLL, Blood, Abstract, Newsroom, ASCO, SLL, Associate, Lymphocytosis, BTK, Society, Hematology, BGNE, Survival, Annual general meeting, Pharmaceutical industry

“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.

Key Points: 
  • “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.
  • Results should be viewed in the context of analysis limitations and available randomized clinical trial data.
  • Data from this analysis provide important insights when evaluating the overall safety profile of individual BTKi treatments.
  • For additional information about BeiGene’s presence at the 2024 ASCO Annual Meeting, please visit our meeting hub in our newsroom .

BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024

Retrieved on: 
tisdag, maj 14, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Oncology, Patient, Chronic lymphocytic leukemia, Risk, MCL, TP53, CLL, CDAC, Blood, BCL2, Acalabrutinib, SLL, Non-Hodgkin lymphoma, Lymphocytosis, Abstract, BTK, Hematology, Mutation, BGNE, Quality of life, Pharmaceutical industry

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.

Key Points: 
  • 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 profile across multiple B-cell malignancies,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
  • “The data highlight the potential of our differentiated investigational BCL2 inhibitor, sonrotoclax, as a monotherapy and in combination regimens, and the promise of BTK degradation to address the unmet needs of patients facing certain blood cancers.”
    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)
    Oral presentation of a Phase 1 study of BeiGene’s novel BCL2 inhibitor sonrotoclax (BGB-11417) in combination with BRUKINSA, demonstrating deep and durable responses with a tolerable safety profile in patients with R/R CLL/SLL; the combination of sonrotoclax with backbone therapy BRUKINSA is being evaluated in the randomized Phase 3 CELESTIAL study ( NCT06073821 ) in patients with TN CLL (Abstract S156)
    Poster presentation of Phase 1a/1b open-label dose escalation and expansion study of sonrotoclax in combination with BRUKINSA in R/R mantle cell lymphoma (MCL), showing the combination was generally well tolerated and demonstrated promising efficacy, including high rate of deep and durable responses (Abstract P1112)
    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:
    Oral presentation of data from the ongoing, first-in-human Phase 1/2 study of BeiGene’s Bruton tyrosine kinase (BTK) degrader BGB-16673, highlighting tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL ( NCT05006716 ); BGB-16673, which induces BTK degradation, is the first investigational drug from BeiGene’s chimeric degradation activation compound (CDAC) platform (Abstract S157)
    Additional data from the Phase 1/2 study of BTK CDAC BGB-16673, demonstrating a tolerable safety profile and preliminary efficacy in heavily pretreated patients with different types of non-Hodgkin lymphoma, including those with BTKi-resistant disease (Abstract P1119)

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

Retrieved on: 
onsdag, maj 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting

Retrieved on: 
onsdag, april 24, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Information, Acalabrutinib, Colorectal cancer, BCL2, Follicular lymphoma, Patient, Comparison, TIS, HPK1, Tislelizumab, Lymphoid leukemia, Pharmaceutical industry

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

Key Points: 
  • Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis
    Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)
    BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia
    Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
    Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study
    Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305
    A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors
    Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
torsdag, februari 29, 2024
Oncology, Health, FDA, Other Science, Science, Pharmaceutical, Biotechnology, Acalabrutinib, BTK, Progression-free survival, Hematology, Physician, Odds ratio, CLL, BGNE, Safety, University, COVID-19, Mayo Clinic, Chronic lymphocytic leukemia, University of Washington, Associate, Patient, Survival, Rituximab, Clutch (eggs), ASCEND, Pharmaceutical industry

The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.

Key Points: 
  • The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.
  • These data will be presented during the 28th Annual International Congress on Hematologic Malignancies® in Miami from February 29 - March 3.
  • “Head-to-head randomized clinical trials are the gold standard when it comes to evaluating the potential impact of individual treatments for patients.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
torsdag, december 14, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Carboplatin, Chemotaxis, Waldenström macroglobulinemia, AstraZeneca, BTK, MCL, Rituximab, B-cell lymphoma, Patient, Ifosfamide, ABC, SWOT, EU4, Etoposide, Follicular lymphoma, Acalabrutinib, Waldenström, RICE, CLL, Axicabtagene ciloleucel, Risk management, Pharmaceutical industry, DLBCL, Phase

The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about CALQUENCE for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the CALQUENCE market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CALQUENCE in DLBCL.

BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023

Retrieved on: 
tisdag, november 28, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Dexamethasone, Multiple myeloma, BCL2, Safety, PST, Tumor lysis syndrome, BGNE, BTK, Lymphoid leukemia, Bone marrow, Harbor Drive, ASH, US Foods, Patient, Abstract, PFS, TLS, Enterprise Community Partners, Q&A, Acalabrutinib, SSE, Blood, Exposition, CDAC, Cancer, Mental health, Recurrence, Orphan, Society, HIV disease progression rates, Pharmaceutical industry, Vaccine, BeiGene, Hematology

BeiGene has 24 abstracts accepted at ASH, with three abstracts scheduled for oral presentations.

Key Points: 
  • BeiGene has 24 abstracts accepted at ASH, with three abstracts scheduled for oral presentations.
  • “Our data at ASH showcase BeiGene’s leadership in the treatment of blood cancers, with promising clinical advances across our pipeline.
  • BeiGene will host an event in San Diego on Sunday, December 10 at 8:00 pm PST for investors and analysts attending ASH.
  • BeiGene senior management and invited speakers will review BeiGene’s pipeline and highlights of the presented data, followed by a Q&A panel.

Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

Retrieved on: 
fredag, december 1, 2023
CNS, NYSE, Food, Arrhythmia, Toxicity, BTK, MCL, HSCT, University, Cytopenia, Disease, Tablet, Bleeding, Patient, SLL, Infection, Hematopoietic stem cell transplantation, FDA, DOR, Acalabrutinib, Lymphocytosis, LLY, Chronic lymphocytic leukemia, Eli Lilly and Company, ORR, IRC, Accelerated approval (FDA), CLL, HIV disease progression rates, Lymphoma, Pharmaceutical industry, Pirtobrutinib

INDIANAPOLIS, Dec. 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Key Points: 
  • The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • "The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors.
  • Patients with active central nervous system (CNS) involvement by lymphoma or allogeneic hematopoietic stem cell transplantation (HSCT) within 60 days were excluded.
  • Patients in the efficacy-eligible population had received a median of five prior lines of therapy (range: 2 to 11).

BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma

Retrieved on: 
torsdag, juni 15, 2023
Biotechnology, Health, Science, Research, Oncology, Neutropenia, SEQUOIA, Rituximab, Obinutuzumab, Lymphocytosis, BGNE, Progression-free survival, Lymphoid leukemia, Atrial fibrillation, ICML, Lymphoma, Lenalidomide, Multimedia, Petechia, BTK, PFS, EMA, MRD, Acalabrutinib, SSE, International Conference on Population and Development, Patient, CEST, Lower respiratory tract infection, Bone marrow, Fever, Recurrence, Abstract, Thrombocytopenia, Conference, Pharmaceutical industry, Hematology, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.
  • View the full release here: https://www.businesswire.com/news/home/20230615000227/en/
    BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma - Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene (Photo: Business Wire)
    “The data presented at ICML provide further evidence supporting our confidence in BRUKINSA.
  • The complete response rate for BRUKINSA in combination with obinutuzumab was 39.3% compared to 19.4% for obinutuzumab alone.
  • The most common grade ≥3 adverse events were neutropenia (23.1%), thrombocytopenia (7.7%), lung infection (5.8%) (Abstract #153)

BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress

Retrieved on: 
fredag, juni 9, 2023
Oncology, Health, General Health, Clinical Trials, Research, Science, Biotechnology, CLL, SEQUOIA, European Medicines Agency, Abstract, Lymphocytosis, Obinutuzumab, BGNE, Doctor of Philosophy, Chronic lymphocytic leukemia, SLL, Progression-free survival, Lymphoid leukemia, Neoplasm, Bone marrow, BTK, PFS, Acalabrutinib, SSE, Patient, CDAC, Blood, EHA, Prevalence, IGHV, Society, Safety, Pharmaceutical industry, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress.
  • BeiGene has ten accepted abstracts at EHA, which is taking place from June 8-11 in Frankfurt, Germany.
  • “We are excited to share the latest research from our robust hematology portfolio and pipeline, including new results that further deepen our understanding of BRUKINSA across a number of hematologic malignancies,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene.
  • The European Medicines Agency recently validated BeiGene’s Type II variation application for BRUKINSA for the treatment of adult patients with R/R FL.