sabatolimab (MBG453) / Novartis 
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 0 Diseases   6 Trials   6 Trials   329 News 


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  • ||||||||||  sabatolimab (MBG453) / Novartis
    The role of TIM-3 in AML and its potential as a therapeutic target to enhance T cell-based cancer immunotherapy (Barcarole (CC West)) -  Nov 5, 2025 - Abstract #DGHO2025DGHO_1640;    
    Our study provides the first evidence of a combination therapeutic approach consisting of TCR-therapy along with hypomethylation drug and TIM-3 checkpoint-blockade as a potential strategy to circumvent immune evasion in AML. Further investigation on the role of TIM-3 and its potential in enhancing immunotherapy is ongoing.
  • ||||||||||  P3 data, Journal:  The conundrum of drug development in higher-risk MDS: Lessons learned from recently failed phase 3 clinical trials. (Pubmed Central) -  Nov 2, 2025   
    Aside from allogeneic transplantation, the current standard of care approach for higher-risk myelodysplastic syndromes/neoplasms (HR-MDS) remains monotherapy with a hypomethylating agent (HMA) including azacitidine, decitabine, or oral decitabine/cedazuridine...In this review, we discuss lessons learned from the recently reported negative trials of azacitidine in combination with eprenetapopt (APR-246), magrolimab, pevonedistat, sabatolimab, tamibarotene, and venetoclax...Instead, we advocate for using the IWG 2023 response criteria to better capture clinically meaningful benefits in HR-MDS. Lastly, we emphasize the need for the scientific community to access patient-level data and samples from failed phase 3 trials in an efficient and expedited fashion to inform the development of subsequent trials.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Enrollment closed, Trial completion date, Trial primary completion date:  MBG453 in Lower Risk MDS (clinicaltrials.gov) -  Sep 29, 2025   
    P2,  N=20, Active, not recruiting, 
    Lastly, we emphasize the need for the scientific community to access patient-level data and samples from failed phase 3 trials in an efficient and expedited fashion to inform the development of subsequent trials. Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Nov 2026 | Trial primary completion date: Jun 2024 --> Nov 2024
  • ||||||||||  sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
    Trial completion date:  Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) -  Sep 10, 2025   
    P1,  N=16, Active, not recruiting, 
    This trial was registered at www.clinicaltrials.gov as #NCT04097821. Trial completion date: Sep 2025 --> Sep 2026
  • ||||||||||  Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Beyond Hypomethylating Agents: Novel Therapies and Targeted Approaches. (Pubmed Central) -  Aug 11, 2025   
    In contrast, exploratory agents such as pevonedistat, magrolimab, and sabatolimab are under further investigation for HR-MDS...Identification of predictive biomarkers for response to targeted therapies and immunotherapies is crucial to optimize patient outcomes. An integrated, patient-centered approach combining genomics, novel therapeutics, and immunomodulation is therefore essential to address the current needs in MDS management.
  • ||||||||||  Jakafi (ruxolitinib) / Incyte
    Trial termination:  ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) -  Aug 7, 2025   
    P1/2,  N=45, Terminated, 
    An integrated, patient-centered approach combining genomics, novel therapeutics, and immunomodulation is therefore essential to address the current needs in MDS management. Completed --> Terminated; Sponsor Decision
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial termination:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Jul 31, 2025   
    P2,  N=39, Terminated, 
    Completed --> Terminated; Sponsor Decision Completed --> Terminated; Lack of efficacy in the program as demonstrated in the earlier CMBG453B12301 (STIMULUS MDS-2) study.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Clinical Features and Preliminary Investigation of PPM1D-Mutated Myeloproliferative Neoplasms (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5918;    
    One patient who had CMML-2 with high-risk features was treated with azacitidine and sabatolimab at diagnosis...Thus, expanded clinical cohorts to further refine the relationship between PPM1D mutations and MPN disease phenotypes coupled with additional mechanistic studies of PPM1D in MPN pathogenesis are required. These findings underscore the complexity of MPNs and highlight avenues for future exploration in precision medicine for patients with PPM1D mutations.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Oct 3, 2024   
    P2,  N=39, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  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, 
    Trial primary completion date: Sep 2027 --> Feb 2028 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, 
    Completed --> Terminated 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, 
    Trial completion date: Mar 2026 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Jul 2024 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