sonrotoclax (BGB-11417) / BeiGene 
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  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, sonrotoclax (BGB-11417) / BeiGene
    BAX Mutated Clonal Hematopoiesis Arises Following Treatment with the BCL2 Inhibitor Class of Therapeutics across a Range of Hematological and Non-Hematological Neoplasms (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_3629;    
    An exploratory 320-mg cohort is currently enrolling. We therefore aimed to investigate the prevalence and pattern of BAX -mutated CH across different hematological and non-hematological neoplasms in response to BCL2 inhibitor therapy (both venetoclax and BGB-11417)...We assessed a cohort of pts with metastatic breast cancer who received venetoclax in combination with tamoxifen (mBEP; Lok, Cancer Discover 2019), and detected BAX variants from peripheral blood samples in 5/16 (31%) pts (median age 66) after a median duration of 20 (range 13
  • ||||||||||  Emerging BCL 2 Inhibitors (LEVEL 3, GENERAL ASSEMBLY) -  Jun 21, 2023 - Abstract #SOHO2023SOHO_212;    
    P1, P1/2,
    Not yet recruiting --> Completed Among 52 patients with hematological malignancies the maximum tolerated dose (MTD) was not reached and no clinical TLS was observed.20 In this study of 22 evaluable patients with RR CLL there was an overall response rate (ORR) of 63.6% (14/22).20 A larger study of 114 patients with RR CLL evaluated lisaftoclax in combination with either the Bruton's tyrosine kinase inhibitor (BTKi) acalabrutinib or the anti CD20 monoclonal antibody rituximab (NCT04215809)...In CLL an overall response rate (ORR) to BGB-1147 of 100% as monotherapy was observed among 8 patients with RR disease.25 In 12 patients with RR MM, the ORR to BGB-1147 in combination with dexamethasone varied from 0
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, BGB-11417 / BeiGene
    BCL2 Family Inhibitors (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_119;    
    In this non-randomized Phase 1 study, patients received AZA x 5 days and VEN x 7-14 days with an ORR of 87%.(3) The Phase III randomized and placebo-controlled VERONA study is the pivotal ongoing study to confirm a benefit in response rate and overall survival, as well as quality of life and improvements in transfusion requirements, with the combination of HMA + BCL2 inhibition as compared to azacitidine alone. Other potent BCL2 inhibitors are also under clinical development, in combination with HMA therapy for AML and high-risk MDS, including the BCL2 inhibitor BGB-11417, with updated results of these and other studies provided at the meeting as available.
  • ||||||||||  sonrotoclax (BGB-11417) / BeiGene
    Trial completion date, Trial primary completion date:  BGB-11417-101: Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies (clinicaltrials.gov) -  Feb 8, 2023   
    P1a/1b,  N=506, Recruiting, 
    Other potent BCL2 inhibitors are also under clinical development, in combination with HMA therapy for AML and high-risk MDS, including the BCL2 inhibitor BGB-11417, with updated results of these and other studies provided at the meeting as available. Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
  • ||||||||||  sonrotoclax (BGB-11417) / BeiGene
    Enrollment change, Trial completion date, Trial primary completion date:  BGB-11417-103: A Study of BGB-11417 in Participants With Myeloid Malignancies (clinicaltrials.gov) -  Aug 19, 2022   
    P1b/2,  N=260, Recruiting, 
    Enrollment is ongoing; data for Waldenström macroglobulinemia and treatment-naïve CLL/SLL are forthcoming. N=110 --> 260 | Trial completion date: Jun 2024 --> Aug 2025 | Trial primary completion date: Feb 2023 --> Dec 2023