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    DRUG:

    cobolimab (TSR-022)

    i
    Other names: TSR-022, TSR 022, WBP 296A, GSK4069889, WBP-296A, WBP296A, GSK-4069889, GSK 4069889, TSR022
    Company:
    AnaptysBio, GSK
    Drug class:
    TIM-3 antagonist
    Related drugs:
    1m
    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 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    2ms
    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)
    2ms
    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)
    5ms
    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)
    6ms
    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)
    7ms
    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)
    8ms
    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)
    9ms
    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)
    9ms
    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)
    10ms
    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)
    1year
    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)
    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
    Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=244, Recruiting, GlaxoSmithKline | N=184 --> 244 | Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Jul 2024 --> Sep 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    over1year
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; Active, not recruiting --> Completed
    Combination therapy • Trial completion • Metastases
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    over1year
    Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov)
    P1b, N=58, Active, not recruiting, Tesaro, Inc. | Trial completion date: Apr 2023 --> Apr 2024
    Trial completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Zejula (niraparib) • albumin-bound paclitaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    over1year
    Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1 | N=184 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2025 ➔ Jul 2024 | Trial primary completion date: Apr 2025 ➔ Jul 2024
    Combination therapy • Trial completion date • Trial primary completion date
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    2years
    Cobolimab With Dostarlimab and Docetaxel in Patients (pts) With Advanced Non-small Cell Lung Cancer (NSCLC) (DKK 2022)
    Approximately 250 pts will be randomized to Ph2 portion with interim analysis planned after ≥18 weeks follow-up; with an additional 500 pts (Arms A–B [n=200 each] and Arm C [n=100]) in Ph3 portion. Funding: GSK (213410, NCT04655976). Previously presented at IASLCWCLC 2021 and submitted to DKK 2022 on behalf of original authors with their permission.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    EGFR mutation • ALK mutation • ROS1 mutation
    |
    docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    over2years
    Cobolimab With Dostarlimab and Docetaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC): COSTAR Lung (IASLC-WCLC 2022)
    An additional 500 patients (n=200 each in Arms A-B and n=100 in Arm C) may be included in the Phase 3 portion.Funding: GSK (213410). Editorial support provided by Fishawack Indicia Ltd., UK, part of Fishawack Health, and funded by GSK.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule)
    |
    ALK mutation • ROS1 mutation • HAVCR2 expression
    |
    docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    over2years
    New Checkpoint Inhibitors on the Road: Targeting TIM-3 in Solid Tumors. (PubMed, Curr Oncol Rep)
    Early phase clinical trials with different anti-TIM-3 monoclonal antibodies have shown a safe toxicity profile, as cobolimab, LY3321367, or sabatolimab; however, the general antitumor activity remains to be determined and further investigations are needed. However, the TIM-3 pathway is highly complex in terms of non-canonical signaling, broad expression by different immune cells and multiple ligands. Different anti-TIM-3 inhibitors are currently on research, either as monotherapy or in combination with other immunotherapies or chemotherapy, aiming to overcome resistance.
    Review • Journal • Checkpoint inhibition • IO biomarker
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    HAVCR2 expression
    |
    sabatolimab (MBG453) • cobolimab (TSR-022) • LY3321367
    over3years
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1, N=828, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Jun 2023 | Trial primary completion date: Dec 2024 --> Jun 2023
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    almost4years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=341, Recruiting, GlaxoSmithKline | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Clinical • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • ICOS (Inducible T Cell Costimulator)
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609)
    almost4years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=341, Recruiting, GlaxoSmithKline | N=105 --> 341
    Clinical • Enrollment change
    |
    BRAF (B-raf proto-oncogene) • ICOS (Inducible T Cell Costimulator)
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609)
    over4years
    A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov)
    P1, N=369, Recruiting, Tesaro, Inc. | Trial primary completion date: Apr 2022 --> Jul 2021
    Clinical • Trial primary completion date • PD(L)-1 Biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdivo (nivolumab) • cisplatin • docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • encelimab (TSR-033)
    over4years
    A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov)
    P1, N=369, Recruiting, Tesaro, Inc. | Trial primary completion date: Jul 2021 --> Apr 2022
    Clinical • Trial primary completion date • PD(L)-1 Biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Opdivo (nivolumab) • cisplatin • docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • encelimab (TSR-033)
    over4years
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024
    Combination therapy • Trial completion date • Trial primary completion date • Clinical
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    over4years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=105, Recruiting, GlaxoSmithKline | Active, not recruiting --> Recruiting
    Clinical • Enrollment open
    |
    BRAF (B-raf proto-oncogene) • ICOS (Inducible T Cell Costimulator)
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609)
    over4years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=106, Active, not recruiting, GlaxoSmithKline | Trial completion date: Jan 2022 --> Jun 2024 | Trial primary completion date: Jan 2021 --> Jun 2024
    Clinical • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • ICOS (Inducible T Cell Costimulator)
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609)
    almost5years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=104, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    BRAF (B-raf proto-oncogene) • ICOS (Inducible T Cell Costimulator)
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609)
    almost5years
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=105, Recruiting, GlaxoSmithKline | Trial primary completion date: Feb 2020 --> Feb 2021
    Clinical • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • ICOS (Inducible T Cell Costimulator)
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609)
    almost5years
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; N=500 --> 718
    Combination therapy • Enrollment change • Clinical
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    over5years
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; Trial completion date: May 2020 --> Dec 2022 | Trial primary completion date: May 2020 --> Dec 2022
    Combination therapy • Trial completion date • Trial primary completion date • Clinical
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    6years
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; N=304 --> 500
    Combination therapy • Enrollment change • Clinical
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    almost7years
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov)
    P1; Trial primary completion date: Jun 2019 --> May 2020 | Trial completion date: Jun 2019 --> May 2020 | Initiation date: Jun 2016 --> Jun 2016
    Combination therapy • Trial completion date • Trial primary completion date • Trial initiation date • Clinical
    |
    MSI (Microsatellite instability) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998