sabatolimab (MBG453) / Novartis 
Welcome,         Profile    Billing    Logout  
 0 Diseases   14 Trials   14 Trials   139 News 


12345»
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Aug 21, 2024   
    P2,  N=39, Active, not recruiting, 
    The integration of ICIs into MDS treatment strategies has the potential to improve patient outcomes and advance personalized therapeutic approaches. Trial completion date: Jun 2024 --> Oct 2024
  • ||||||||||  sabatolimab (MBG453) / Novartis, nisevokitug (NIS793) / Novartis, Ilaris (canakinumab) / Novartis
    Trial termination:  Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov) -  May 20, 2024   
    P1,  N=33, Terminated, 
    Trial completion date: Jun 2024 --> Oct 2024 Active, not recruiting --> Terminated; Business reasons
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Enrollment closed, Enrollment change:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  May 20, 2024   
    P2,  N=39, Active, not recruiting, 
    Active, not recruiting --> Terminated; Business reasons Recruiting --> Active, not recruiting | N=90 --> 39
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date, Trial primary completion date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Apr 23, 2024   
    P2,  N=90, Recruiting, 
    N=27 --> 59 | Trial completion date: Apr 2027 --> Aug 2024 | Trial primary completion date: Nov 2024 --> Jul 2024 | Active, not recruiting --> Recruiting Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Enrollment open, Trial completion date, Trial primary completion date:  MBG453 in Lower Risk MDS (clinicaltrials.gov) -  Mar 12, 2024   
    P2,  N=20, Recruiting, 
    Recruiting --> Active, not recruiting | N=59 --> 27 Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Jan 2026 | Trial primary completion date: Jun 2022 --> Jun 2024
  • ||||||||||  azacitidine / Generic mfg.
    Journal:  Frontline treatment options for higher-risk MDS: can we move past azacitidine? (Pubmed Central) -  Dec 9, 2023   
    Notably, azacitidine + venetoclax, azacitidine + sabatolimab, and azacitidine + magrolimab have shown exciting results in large, single-arm studies and have completed accrual in placebo-controlled, double-blind studies with OS as a primary endpoint. We all eagerly await the results of these studies.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Single-Cell Multiomics Analysis Reveals Potential Drivers of Response to the Anti-TIM3 Inhibitor Sabatolimab Combined with Azacitidine in MDS and CMML (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_5755;    
    P1b
    Conversely, we observed a down-regulation of metallothionein genes ( MT1E, MT1G, MT2A ) as well as a collection of transcription factors ( NR4A1, FOSL2, JUN, CEBPB, CEBPD ), NF-?B inhibitors ( NFKBIZ, NFKBIA ) and CXCL8 in the post-treatment samples (FDR <0.1). Conclusions Our study provides one of the most comprehensive evaluations of the cellular dynamics of anti-TIM3 immunotherapy in patients to date, allowing for the nomination of novel putative predictive biomarkers of response and identification of potential immunomodulatory mechanisms induced by the combination of sabatolimab with azacitidine in MDS and CMML for further future analysis.
  • ||||||||||  sabatolimab (MBG453) / Novartis, nisevokitug (NIS793) / Novartis, Ilaris (canakinumab) / Novartis
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov) -  Oct 6, 2023   
    P1,  N=33, Active, not recruiting, 
    Cytopenias occurred at low rates, were generally G1 Recruiting --> Active, not recruiting | N=90 --> 33 | Trial completion date: Sep 2024 --> May 2024 | Trial primary completion date: Sep 2024 --> May 2024
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion, Combination therapy:  Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) -  Oct 2, 2023   
    P1b,  N=241, Completed, 
    Recruiting --> Active, not recruiting | N=90 --> 33 | Trial completion date: Sep 2024 --> May 2024 | Trial primary completion date: Sep 2024 --> May 2024 Active, not recruiting --> Completed
  • ||||||||||  sabatolimab (MBG453) / Novartis
    TIM-3+ natural killer cell dysfunction is driven by galectin-9 in head and neck squamous cell carcinoma (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1314;    
    Galectin-9-induced effects on cytotoxicity can be abrogated using the clinical-grade anti-TIM-3 blocking antibody, MBG453...This may be due to higher intratumoral galectin-9 protein expression in HPV+ HNSCC lesions. Conclusions Our data stress the importance and complexity of TIM-3 in the context of NK cells and suggest that targeting the TIM-3/galectin-9 pathway may be a cogent immunotherapeutic strategy to reinvigorate NK cell effector function in HPV+ HNSCC patients.
  • ||||||||||  An Update on Higher Risk Myelodysplastic Syndromes () -  Aug 31, 2023 - Abstract #SOHO2023SOHO_939;    
    Therapies The current treatment landscape for HR-MDS is limited to HMA monotherapy, either parenteral (azacitidine or decitabine) or a more recently available oral option (decitabine/cedazuridine), followed by allogeneic hematopoietic stem cell transplant when feasible based on patient fitness and donor availability.14,15 There is a great need for alternative agents in the front-line and HMA-failure settings, as outcomes are particularly dismal in the latter.16,17 Unfortunately, drug development in MDS has been hampered by poorly-understood disease biology, lack of quality animal models, broad heterogeneity in disease phenotype, and suboptimal patient accrual to trials.18,19 Therapies more recently approved in AML are now being evaluated in HR-MDS. Liposomal daunorubicin/cytarabine (CPX-351) in the front-line setting has some promising, albeit limited, data published so far.20
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion date, Combination therapy:  Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) -  Jul 5, 2023   
    P1,  N=16, Active, not recruiting, 
    Liposomal daunorubicin/cytarabine (CPX-351) in the front-line setting has some promising, albeit limited, data published so far.20 Trial completion date: Sep 2024 --> Sep 2025
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion date, Trial primary completion date, Combination therapy:  Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) -  May 19, 2023   
    P1b,  N=241, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Apr 2023 --> Sep 2023
  • ||||||||||  sabatolimab (MBG453) / Novartis, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD), magrolimab (GS-4721) / Ono Pharma, Gilead
    Antibody-Based Therapy of MDS (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_122;    
    Magrolimab is an anti-CD47 antibody which is currently in late stage development in MDS; it has been combined with azacitidine based on preclinical data suggesting synergistic activity and is currently being studied in the phase III ENHANCE study comparing azacitidine to azacitidine+magrolimab...Sabatolimab is an anti-TIM-3 antibody currently being studied in MDS in the phase III STIMULUS trial, comparing azacitidine+placebo to azacitidine+sabatolimab...Luspatercept is a fusion protein which incorporates the Fc portion of the IgG heavy chain, fused to a modified extracellular domain of the activin receptor type IIB (ActRIIB)...Together, antibody-based therapies represent a promising new therapeutic area in MDS. This abstract will review the current landscape of antibody-based therapeutics in MDS, including data for their use to target immune checkpoints, cancer-specific ligands, and also as part of ligand traps for relevant signaling pathways that are overactive in MDS.
  • ||||||||||  Therapy of TP53 Mut MDS (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_121;    
    P3
    This abstract will review the current landscape of antibody-based therapeutics in MDS, including data for their use to target immune checkpoints, cancer-specific ligands, and also as part of ligand traps for relevant signaling pathways that are overactive in MDS. These data supported the phase 3 study of APR-246 in combination with azacitidine versus azacitidine alone (NCT03745716)...We have reported the phase Ib study combining magrolimab with azacitidine in treatment-na
  • ||||||||||  Keynote lecture: Attempts to Improve Hypomethylating Agent-Based Regimens: A Ten-Year Experience (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_42;    
    Despite these past pitfalls, the MDS community is awaiting several major randomized studies, evaluating venetoclax, sabatolimab, magrolimab and tamibatorene. While these studies are not entirely free of the criticisms mentioned above, it is hoped that the efficacy of these treatments will be sufficient to overcome them.
  • ||||||||||  Journal, PD(L)-1 Biomarker, IO biomarker:  Biological therapy in elderly patients with acute myeloid leukemia. (Pubmed Central) -  Mar 9, 2023   
    We further explore mechanisms and effectiveness of medications that modify the microenvironment, such as glasdegib, or that harness the immune system against leukemia, such as CD47 antibody magrolimab, PD1/PDL1 inhibitors pembrolizumab and nivolumab, TIM3 inhibitor sabatolimab, T-cell and NK-cell engagers...In this scenario, a brief overview of the mechanism of action of target agents is provided, particularly with respect to their biological mechanisms. Overall, this therapeutic armamentarium will constitute the basis for multimodal and personalized combinations that, in the idea of precision medicine, will enormously benefit elderly AML patients.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date, Trial primary completion date, Combination therapy:  STIMULUS-MDS3: A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants (clinicaltrials.gov) -  Jan 20, 2023   
    P2,  N=20, Active, not recruiting, 
    Overall, this therapeutic armamentarium will constitute the basis for multimodal and personalized combinations that, in the idea of precision medicine, will enormously benefit elderly AML patients. Trial completion date: May 2026 --> Apr 2023 | Trial primary completion date: May 2026 --> Apr 2023
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Journal, Checkpoint inhibition:  TIM-3: a tumor-associated antigen beyond checkpoint inhibition? (Pubmed Central) -  Nov 22, 2022   
    By targeting TIM-3, a receptor expressed on various immune effector cells as well as myeloid cells, multiple mechanisms of action that are distinct from canonical immune checkpoint inhibitors are in play - (i) blockade of TIM-3 and its ligands PtdSer/galectin-9, (ii) modulation of leukemic cell self-renewal as well as (iii) antibody-dependent phagocytosis of TIM-3-expressing leukemic cells. Novel immunotherapies such as sabatolimab which enhance the antitumor immune response on converging fronts represent the promise of a continuously replenished armoury for the treatment of cancer.
  • ||||||||||  Jakafi (ruxolitinib) / Novartis, Incyte
    Enrollment closed:  ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) -  Nov 15, 2022   
    P1/2,  N=46, Active, not recruiting, 
    Novel immunotherapies such as sabatolimab which enhance the antitumor immune response on converging fronts represent the promise of a continuously replenished armoury for the treatment of cancer. Suspended --> Active, not recruiting