Sonrotoclax
- Generic Name
- Sonrotoclax
BeiGene to Present Extensive Hematology Data at EHA 2025, Showcasing BRUKINSA and Next-Generation Therapies
• BeiGene will present 31 abstracts at the European Hematology Association Congress in Milan, highlighting data from its BTK inhibitor BRUKINSA and investigational pipeline assets sonrotoclax and BGB-16673.
• The company's next-generation pipeline assets have demonstrated promising clinical activity and safety profiles across multiple B-cell malignancies, with over 2,500 patients enrolled globally in clinical trials.
• Four oral presentations will feature updated results from clinical studies of BGB-16673 in CLL/SLL and WM, as well as sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL.
Promising Pipeline for Mantle Cell Lymphoma Treatment: 22+ Therapies Under Development by 20+ Companies
• DelveInsight's latest report reveals a robust pipeline with 20+ companies developing 22+ therapies for mantle cell lymphoma, highlighting significant advancement in treatment options for this rare blood cancer.
• Recent approvals include AstraZeneca's CALQUENCE® (acalabrutinib) combination therapy for previously untreated MCL patients ineligible for stem cell transplantation, marking an important treatment milestone.
• Key emerging therapies include Venetoclax (AbbVie), ADI-001 (Adicet Bio), and BGB-11417 (BeiGene), with multiple compounds targeting novel mechanisms of action across various clinical development stages.
B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025
• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area.
• Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025.
• Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.
DARZALEX Dominates Multiple Myeloma Market with $11.6 Billion in Global Sales
• DARZALEX (daratumumab), Janssen's CD38-targeting monoclonal antibody, has transformed multiple myeloma treatment across all lines of therapy, generating $11.6 billion in worldwide sales in 2024.
• The drug's success stems from its versatility in combination regimens, expanded approvals for both newly diagnosed and relapsed/refractory patients, and the introduction of DARZALEX FASPRO, a convenient subcutaneous formulation.
• Despite growing competition from emerging therapies like Sanofi's SARCLISA and novel BCMA-targeting agents, DARZALEX maintains market leadership through first-mover advantage and robust clinical efficacy data.
FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma
• The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
• In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
• This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.
BeiGene's Brukinsa and Novel Assets Show Promise in CLL Treatment at ASH 2024
• BRUKINSA demonstrated a 71% reduction in progression or death risk compared to bendamustine-rituximab in treatment-naïve CLL patients over a 5-year follow-up.
• Sonrotoclax combined with BRUKINSA showed a 99% overall response rate in treatment-naïve CLL, with no progression observed after 1.5 years.
• BGB-16673, a BTK degrader, exhibited a 94% overall response rate in treatment-resistant CLL, highlighting its potential in addressing unmet needs.
Acalabrutinib Plus Venetoclax Significantly Improves PFS in Untreated CLL
• The phase 3 AMPLIFY trial demonstrated that acalabrutinib plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) in treatment-naive CLL patients.
• The doublet and triplet regimens reduced the risk of disease progression or death by 35% and 58%, respectively, compared to chemoimmunotherapy.
• The highest rates of undetectable minimal residual disease (uMRD) were observed in patients treated with the triplet regimen of acalabrutinib, venetoclax, and obinutuzumab.
• The combination provides a chemotherapy-free, fixed-duration option for previously untreated CLL, offering improved outcomes and flexibility in managing the disease.
FDA Approves Revumenib for Relapsed/Refractory KMT2A-Rearranged Acute Leukemia
• The FDA has approved revumenib (Revuforj; Syndax Pharmaceuticals) as a first-in-class therapy for relapsed or refractory acute leukemia with KMT2A rearrangements.
• Revumenib, a menin inhibitor, targets the interaction between menin and KMT2A protein, which is crucial for the leukemogenic process in KMT2Ar leukemia.
• Clinical trials showed revumenib significantly improved remission rates compared to historical controls, with a complete remission rate of 22.8% in the AUGMENT-101 trial.
• Pharmacists play a vital role in optimizing dosing, monitoring for adverse events like QTc prolongation and differentiation syndrome, and ensuring patient safety.
Mantle Cell Lymphoma Pipeline Shows Promise with Novel Targeted Therapies
• The Mantle Cell Lymphoma (MCL) pipeline is robust, featuring over 20 companies developing more than 22 therapies.
• Key players like AbbVie and BeiGene are advancing novel drugs, including BTK inhibitors and Bcl-2 inhibitors, to improve MCL treatment.
• Clinical trials are evaluating promising therapies such as Venetoclax, ADI-001, and Orelabrutinib across various phases.
• Recent data highlights potential for combination therapies and novel mechanisms like BTK degradation in MCL treatment.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath