sabatolimab (MBG453) / Novartis 
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 0 Diseases   14 Trials   14 Trials   139 News 


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  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial initiation date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Jan 20, 2022   
    P2,  N=90, Not yet recruiting, 
    Recruiting --> Active, not recruiting Initiation date: Nov 2021 --> Mar 2022
  • ||||||||||  Clinical, Review, Journal:  Management of patients with higher-risk myelodysplastic syndromes after failure of hypomethylating agents: What is on the horizon? (Pubmed Central) -  Jan 14, 2022   
    Thanks to advances in the understanding of the molecular and biologic pathogenesis of MDS, several novel targeted agents such as the BCL-2 inhibitor venetoclax, TP-53 refolding agent APR-246, IDH1/2 inhibitors, and novel ICPIs such as magrolimab and sabatolimab have been developed and demonstrated activity in combination with HMA in the frontline setting...Furthermore, the biology of HMA failure remains poorly defined which significantly limits rationale drug development. This highlights the importance of optimization of frontline therapy to avoid/delay HMA failure in addition to development of more effective salvage therapies.
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases:  Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) -  Dec 10, 2021   
    P1/2,  N=252, Active, not recruiting, 
    This highlights the importance of optimization of frontline therapy to avoid/delay HMA failure in addition to development of more effective salvage therapies. Trial completion date: Nov 2021 --> Mar 2022 | Trial primary completion date: Nov 2021 --> Mar 2022
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial initiation date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Dec 10, 2021   
    P2,  N=90, Not yet recruiting, 
    Trial completion date: Nov 2021 --> Mar 2022 | Trial primary completion date: Nov 2021 --> Mar 2022 Initiation date: Aug 2021 --> Nov 2021
  • ||||||||||  azacitidine / Generic mfg.
    Journal:  Advances in myelodysplastic syndrome. (Pubmed Central) -  Nov 29, 2021   
    Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Better diagnosis and prognostic stratification may allow a more precise and personalized treatment of MDS with novel agent combinations leading to improved therapeutic algorithms.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Sabatolimab (MBG453) Combination Treatment Regimens for Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS): The MDS Studies in the Stimulus Immuno-Myeloid Clinical Trial Program () -  Nov 24, 2021 - Abstract #ASH2021ASH_6879;    
    P1b, P2, P
    STIMULUS-MDS2 (NCT04266301) is an ongoing, international, randomized, double-blind, placebo-controlled, Ph III trial of sabatolimab + azacitidine (AZA) in pts with vH/H/IR-MDS or chronic myelomonocytic leukemia-2...STIMULUS MDS-US (NCT04878432) is a US-based, open-label, single-arm, Ph II trial investigating sabatolimab + HMAs of investigators' choice (AZA intravenous [IV] or subcutaneous, decitabine IV or oral decitabine) in pts with vH/H/IR-MDS...STIMULUS-MDS3 (NCT04812548) is an international, open-label, single-arm, Ph II trial that explores triplet therapy of sabatolimab combined with AZA and the BCL-2 inhibitor venetoclax (VEN) in pts with vH/HR-MDS...The STIMULUS immuno-myeloid clinical trial program is investigating the efficacy, safety, and improved quality of life of multiple sabatolimab-based combination therapies in pts with myeloid malignancies. The goal of ongoing STIMULUS-MDS trials is to gain insight into the promising durable benefit of sabatolimab combination therapies in pts with HR-MDS.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Allogeneic Hematopoietic Cell Transplantation Outcomes of Patients with R/R AML or Higher-Risk MDS Treated with the TIM-3 Inhibitor MBG453 (Sabatolimab) and Hypomethylating Agents (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5370;    
    P1b
    One patient also received the anti-PD1 antibody spartalizumab...GVHD prophylaxis included post-transplant cyclophosphamide based approaches (n=6), tacrolimus and methotrexate (n=9), and CsA, MMF, and ATG (n=1)...Summary/Conclusion : Transplant outcomes for patients treated with the anti-TIM3 antibody sabatolimab in combination with HMA for high risk MDS and AML are generally favorable; toxicities related to GVHD were in line with historical rates in this limited cohort. Patients with RAS mutated disease did not have the poor outcomes previously described in this subgroup, while patients with TP53 mutated disease remain high risk.
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion date, Trial primary completion date, Combination therapy:  Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) -  Sep 28, 2021   
    P1,  N=15, Recruiting, 
    Trial primary completion date: Oct 2023 --> Apr 2022 Trial completion date: Feb 2024 --> Sep 2024 | Trial primary completion date: Feb 2022 --> Sep 2022
  • ||||||||||  Revlimid (lenalidomide) / BMS
    Immunotherapeutic approaches to MDS - new perspectives (A2) -  Sep 20, 2021 - Abstract #DGHO2021DGHO_492;    
    Antigen-targeted therapeutic approaches including cellular immunestrategies using CAR-T cells and bispecific T-cell engager (BiTEs) are currently evaluated in preclinical models and early clinical trials for the treatment of higher risk MDS. In summary, immunotherapeutic treatment strategies have the potential to provide disease control with an acceptable side effect profile, especially in higher risk MDS patients who are ineligible for allogeneic stem cell transplantation.
  • ||||||||||  Revlimid (lenalidomide) / BMS
    [VIRTUAL] Treatment of Higher-Risk MDS () -  Sep 6, 2021 - Abstract #SOHO2021SOHO_372;    
    P3
    There are currently a number of phase IIitrials evaluating novel combinations in higher-risk MDS, including HMA combined with pevonedistat (NCT03268954); APR-246 in TP53-mutant MDS (NCT03745716)’; the anti-TIM3 antibody MBG453 (NCT04266301); the anti-CD47 antibody magrolimab (NCT04313881); and venetoclax (NCT04401748). New active agents to add to the treatment repertoire would be welcome and may allow for new approaches to disease, including different strategies at diagnosis, for consolidation of response, and in the maintenance setting.
  • ||||||||||  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) -  Aug 18, 2021   
    P1b,  N=243, Active, not recruiting, 
    Trial completion date: May 2027 --> Jan 2027 | Trial primary completion date: May 2027 --> Jan 2027 Trial completion date: Nov 2021 --> Jun 2022 | Trial primary completion date: Nov 2021 --> Jun 2022
  • ||||||||||  azacitidine / Generic mfg.
    [VIRTUAL] Targeting p53 in MDS () -  May 20, 2021 - Abstract #SOHO2021SOHO_118;    
    P1, P1b, P
    Other novel HMA combinations have recently had high ORR/CR rates as frontline therapy, which include sabatolimab and pevonedistat, although unclear molecular subset data in TP53 mutant patients...Specifically, PDL1 has been shown to be upregulated on TP53 mutant hematopoietic stem cells and bone marrow blasts.17,18 Importantly, TP53 mutant AML patients have been strongly associated with an adverse immune microenvironment and potentially may be an optimal molecular subset for novel immunomodulatory agents.19 In this regard the bispecific agent flotetuzumab targeting CD123 has had activity in TP53 mutant relpased refractory disease (7 of 15 pts with objective response although with median OS of < 12 months).20 Conclusions TP53 mutant MDS/AML patients represent a molecular cohort with very poor outcomes and lack of disease modifying therapy...The treatment landscape of these patients is encouraging as the combination of azacitidine with APR-246 or magrolimab have been well tolerated and produced significantly improved response rates. Ideally, future translational data will further elucidate the underpinnings driving the poor outcomes for this molecular subgroup to lead to additional novel therapeutic strategies.
  • ||||||||||  azacitidine / Generic mfg.
    [VIRTUAL] BCL-2 Inhibition in MDS () -  May 20, 2021 - Abstract #SOHO2021SOHO_116;    
    P1b, P3
    Pre-clinical studies show activity for venetoclax is enhanced in higher-risk compared to lower-risk MDS, suggesting that vulnerability to BCL-2 targeting may be enhanced as the disease progresses over time.2,3 The clinical rationale to combine venetoclax with azacitidine was linked to the existing role of hypomethylating agents in MDS and the promising results observed for the venetoclax/azacitidine combination in older patients with AML, including sub-groups with AML secondary to MDS.4 Clinical Experience with Venetoclax Combined with Azacitidine in MDS Hypomethylating agents (HMAs) represent the current standard of care for patients with higher-risk MDS (HR-MDS) who are ineligible for allogeneic hematopoietic stem cell transplant (HSCT)...Comparison with Other Emerging MDS Therapies In addition to ven-aza for higher-risk MDS, magrolimab, pevonedistat, and sabatolimab are also in advanced stages of clinical development, with the goal of enhancing patient outcomes compared to azacitidine alone...Each of these therapeutic options are undergoing phase 3 evaluation. The results of these studies have potential to have a major impact on the way higher-risk MDS will be managed in the future.