^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    TIM-3 antagonist

    Related drugs:
    3d
    STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov)
    P1/2, N=24, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Dec 2024 --> Aug 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    azacitidine • sabatolimab (MBG453)
    16d
    ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution As Pre-emptive Therapy in AML): a Multi-arm, Precision-based, Recursive, Platform Trial (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    azacitidine • sabatolimab (MBG453)
    18d
    STIMULUS-MDS2: Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (clinicaltrials.gov)
    P3, N=530, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    azacitidine • sabatolimab (MBG453)
    23d
    COSTAR Lung: Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy (clinicaltrials.gov)
    P3, N=758, Active, not recruiting, GlaxoSmithKline | Phase classification: P2/3 --> P3 | Trial primary completion date: Oct 2024 --> Apr 2025
    Phase classification • Trial primary completion date • Metastases • Cost of therapy
    |
    docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    29d
    TSR-022 (anti-TIM-3 Antibody) and TSR-042 (anti-PD-1 Antibody) in Patients with Liver Cancer (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, University of Hawaii | Recruiting --> Active, not recruiting | Trial completion date: Oct 2025 --> Oct 2027
    Enrollment closed • Trial completion date • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    1m
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=39, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    2ms
    HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
    P1, N=52, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business decision
    Trial termination • Combination therapy
    |
    TP53 (Tumor protein P53)
    |
    TP53 wild-type
    |
    Venclexta (venetoclax) • sabatolimab (MBG453) • siremadlin (HDM201)
    2ms
    STIMULUS-MDS1: A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). (clinicaltrials.gov)
    P2, N=127, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    azacitidine • sabatolimab (MBG453)
    2ms
    Sabatolimab in combination with spartalizumab in patients with non-small cell lung cancer or melanoma who received prior treatment with anti-PD-1/PD-L1 therapy: a phase 2 multicentre study. (PubMed, BMJ Open)
    Sabatolimab plus spartalizumab was well tolerated in patients with advanced/metastatic melanoma or NSCLC who had progressed following antiprogrammed death-1/antiprogrammed death-ligand 1 treatment. Limited antitumour activity was observed. The tolerability of sabatolimab administration supports the potential to explore treatment with sabatolimab in various combination regimens and across a spectrum of tumour types.
    P2 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    spartalizumab (PDR001) • sabatolimab (MBG453)
    3ms
    CPDR001X2105: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov)
    P1, N=241, Completed, Novartis Pharmaceuticals | Phase classification: P1b --> P1
    Phase classification
    |
    azacitidine • decitabine • spartalizumab (PDR001) • sabatolimab (MBG453)
    3ms
    STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov)
    P1/2, N=24, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    azacitidine • sabatolimab (MBG453)
    3ms
    Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov)
    P2, N=70, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Sep 2027 --> Feb 2028
    Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • decitabine • spartalizumab (PDR001) • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    3ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2024 --> Oct 2024
    Trial completion date
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    3ms
    STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • sabatolimab (MBG453)
    3ms
    STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov)
    P1/2, N=24, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=59 --> 24
    Enrollment closed • Enrollment change
    |
    azacitidine • sabatolimab (MBG453)
    4ms
    A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov)
    P1/2, N=131, Not yet recruiting, GlaxoSmithKline
    New P1/2 trial • Combination therapy
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    5ms
    Neo-MEL-T: Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma (clinicaltrials.gov)
    P2, N=56, Recruiting, Diwakar Davar | Trial completion date: Oct 2027 --> Apr 2029 | Trial primary completion date: Jan 2025 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    5ms
    STIMULUS-MDS3: A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants (clinicaltrials.gov)
    P2, N=20, Terminated, Novartis Pharmaceuticals | Completed --> Terminated; Study was stopped following a strategic decision from the Sponsor. It was not based on any safety findings or safety concerns with sabatolimab.
    Trial termination • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • sabatolimab (MBG453)
    6ms
    Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov)
    P1, N=58, Active, not recruiting, Tesaro, Inc. | Trial completion date: Apr 2024 --> Aug 2024
    Trial completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Zejula (niraparib) • albumin-bound paclitaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    6ms
    Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov)
    P1, N=33, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination
    |
    sabatolimab (MBG453) • Ilaris (canakinumab) • nisevokitug (NIS793)
    6ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=90 --> 39
    Enrollment closed • Enrollment change
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    6ms
    A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov)
    P1, N=475, Recruiting, Tesaro, Inc. | Trial completion date: Jul 2025 --> Apr 2027 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • encelimab (TSR-033)
    7ms
    STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov)
    P1/2, N=59, Recruiting, Novartis Pharmaceuticals | N=27 --> 59 | Trial completion date: Apr 2027 --> Aug 2024 | Trial primary completion date: Nov 2024 --> Jul 2024 | Active, not recruiting --> Recruiting
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    azacitidine • sabatolimab (MBG453)
    7ms
    Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov)
    P2, N=70, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2028 --> Feb 2028
    Trial completion date
    |
    Venclexta (venetoclax) • azacitidine • decitabine • spartalizumab (PDR001) • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    7ms
    STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • sabatolimab (MBG453)
    7ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=90, Recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    7ms
    A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Novartis Pharmaceuticals | N=63 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    azacitidine • magrolimab (ONO-7913) • sabatolimab (MBG453)
    8ms
    A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov)
    P1, N=475, Recruiting, GlaxoSmithKline
    New P1 trial • Metastases
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • encelimab (TSR-033)
    8ms
    STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov)
    P1/2, N=27, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=59 --> 27
    Enrollment closed • Enrollment change
    |
    azacitidine • sabatolimab (MBG453)
    8ms
    MBG453 in Lower Risk MDS (clinicaltrials.gov)
    P2, N=20, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Jan 2026 | Trial primary completion date: Jun 2022 --> Jun 2024
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Chr del(5q)
    |
    sabatolimab (MBG453)
    8ms
    Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=66, Recruiting, Meghan Shea | Not yet recruiting --> Recruiting | Initiation date: Jul 2024 --> Mar 2024
    Enrollment open • Trial initiation date • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    9ms
    STIMULUS-MDS2: Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (clinicaltrials.gov)
    P3, N=530, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2027 --> Sep 2024 | Trial primary completion date: Jan 2027 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    azacitidine • sabatolimab (MBG453)
    9ms
    Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Meghan Shea
    New P2 trial • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    11ms
    Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Trial completion date • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    spartalizumab (PDR001) • sabatolimab (MBG453)
    11ms
    Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov)
    P1, N=58, Active, not recruiting, Tesaro, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Zejula (niraparib) • albumin-bound paclitaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    11ms
    Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase 2 trial. (PubMed, Lancet Haematol)
    The addition of sabatolimab to hypomethylating agents in this study did not result in a significant improvement in complete response rates or progression-free survival. Sabatolimab had a manageable safety in most patients with higher-risk myelodysplastic syndromes. A randomised phase 3 trial is ongoing to assess the potential benefit of sabatolimab plus azacitidine on overall survival in this setting.
    P2 data • Journal
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    azacitidine • decitabine • sabatolimab (MBG453)
    12ms
    Phase Ib study of sabatolimab (MBG453), a novel immunotherapy targeting TIM-3 antibody, in combination with decitabine or azacitidine in high- or very high-risk myelodysplastic syndromes. (PubMed, Am J Hematol)
    Sabatolimab + HMA had a safety profile similar to that reported for HMA alone and demonstrated durable clinical responses in patients with HR/vHR-MDS. These results support the ongoing evaluation of sabatolimab-based combination therapy in MDS, CMML, and acute myeloid leukemia.
    P1 data • Journal • Combination therapy
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    azacitidine • decitabine • sabatolimab (MBG453)
    1year
    COSTAR Lung: Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy (clinicaltrials.gov)
    P2/3, N=758, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases • Cost of therapy
    |
    docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    1year
    Clinical Characteristics and Outcomes of Myeloid Neoplasms with Mecom Rearrangement: Results from a Nationwide Multicenter Study (ASH 2023)
    Among 3 MDS with MECOM rearrangement, one patient received azacitidine with investigational drug (sabatolimab/placebo) and achieved complete hematologic response. Chemotherapy should be avoided in this subtype due to non-responsiveness, hypomethylating agent showed benefit and can be considered as a bridging treatment before stem cell transplantation. Novel therapy targeting MECOM gene should be further explored to improve outcomes in this AML subtype.
    Clinical
    |
    MECOM (MDS1 And EVI1 Complex Locus)
    |
    MECOM rearrangement
    |
    azacitidine • sabatolimab (MBG453)
    1year
    Single-Cell Multiomics Analysis Reveals Potential Drivers of Response to the Anti-TIM3 Inhibitor Sabatolimab Combined with Azacitidine in MDS and CMML (ASH 2023)
    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-κB 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.
    IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD74 (CD74 Molecule) • IFNG (Interferon, gamma) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • GZMA (Granzyme A) • HLA-DPA1 (Major Histocompatibility Complex, Class II, DP Alpha 1) • IFIT1 (Interferon Induced Protein With Tetratricopeptide Repeats 1) • IL32 (Interleukin 32) • IFI27 (Interferon Alpha Inducible Protein 27) • NFKBIA (NFKB Inhibitor Alpha 2) • NR4A1 (Nuclear Receptor Subfamily 4 Group A Member 1) • FOSL2 (FOS Like 2) • IFIT2 (Interferon Induced Protein With Tetratricopeptide Repeats 2) • MT1E (Metallothionein 1E)
    |
    IFNG expression • MHC-II expression
    |
    azacitidine • sabatolimab (MBG453)
    1year
    Molecular Measurable Residual Disease (MRD) Clearance (≤1%) Is Associated with Improved Clinical Outcomes in Patients with Higher-Risk Myelodysplastic Neoplasms (HR-MDS): An Exploratory Analysis of Stimulus-MDS1 in Patients Receiving Sabatolimab or Placebo + Hypomethylating Agent (HMA) (ASH 2023)
    Treatment-naive pts aged ≥18 years with intermediate (+ ≥5% bone marrow [BM] blasts), high or very high risk MDS by Revised International Prognostic Scoring System were randomized to sabatolimab or placebo added to azacitidine/decitabine (Zeidan AM, et al. We present the first results from a prospective, controlled, randomized study demonstrating the potential prognostic value of MRD for PFS and OS in HR-MDS. Our results demonstrate high NGS concordance between PBMC and BMMC on-treatment samples, indicating that PBMC could represent an alternative for clonal monitoring. Interestingly, more pts treated with sabatolimab + HMA reached MRD negativity while in remission, potentially explaining the longer DoR in pts receiving sabatolimab + HMA vs placebo + HMA.
    Clinical • Clinical data • IO biomarker
    |
    DNMT3A (DNA methyltransferase 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2)
    |
    DNMT3A mutation • ASXL1 mutation • TET2 mutation
    |
    azacitidine • decitabine • sabatolimab (MBG453)
    1year
    TIM-3 Inhibitor Sabatolimab for Patients with Acute Myeloid Leukemia (AML) with Measurable Residual Disease (MRD) Detected after Allogeneic Stem Cell Transplantation (AlloSCT): Preliminary Findings from the Phase Ib/II Stimulus-AML2 Study (ASH 2023)
    In adult pts with AML who are in hematological CR with MRD+ after alloSCT, sabatolimab 400 mg and 800 mg monotherapies were well tolerated. Cytopenias occurred at low rates, were generally G1–2 and mostly related to imminent relapse. Importantly, there were no cases of GvHD reported or any immune-related AEs commonly seen with checkpoint inhibitors.
    Clinical • P1/2 data
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • WT1 (WT1 Transcription Factor) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD34 (CD34 molecule)
    |
    azacitidine • sabatolimab (MBG453)