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    DRUG:

    LY3321367

    i
    Other names: LY3321367, LY 3321367
    Associations

    News

    Trials
    Company:
    Eli Lilly
    Drug class:
    TIM-3 inhibitor
    Related drugs:
    Associations

    News

    Trials
    3ms
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=164, Completed, Eli Lilly and Company | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    8ms
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=215, Active, not recruiting, Eli Lilly and Company | Trial completion date: Mar 2024 --> Jul 2024
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    11ms
    Beyond PD(L)-1 Blockade in Microsatellite-Instable Cancers: Current Landscape of Immune Co-Inhibitory Receptor Targeting. (PubMed, Cancers (Basel))
    Ipilimumab (anti-CTLA4) is the only immune checkpoint inhibitor (ICI) non-targeting PD(L)-1 that has been approved so far by the FDA for MSI-H cancer, namely, CRC in combination with nivolumab. Anti-TIM3 antibody LY3321367 showed interesting clinical activity in combination with anti-PDL-1 antibody in patients with MSI-H cancer not previously treated with anti-PD(L)-1...In conclusion, several combination therapies of ICIs and novel strategies are emerging and may revolutionize the treatment paradigm of MSI-H patients in the future. A huge effort will be necessary to find reliable immune biomarkers to personalize therapeutical decisions.
    Review • Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • BTLA (B And T Lymphocyte Associated) • IL5 (Interleukin 5) • LAIR1 (Leukocyte Associated Immunoglobulin Like Receptor 1)
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • LY3321367
    1year
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=215, Active, not recruiting, Eli Lilly and Company | Phase classification: P1a/1b --> P1 | Trial completion date: Dec 2023 --> Mar 2024
    Phase classification • Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    1year
    A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=209, Completed, Eli Lilly and Company | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Aug 2023
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    lodapolimab (LY3300054) • LY3321367
    2years
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=215, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    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
    Safety and antitumor activity of α-PD-L1 antibody as monotherapy or in combination with α-TIM-3 antibody in patients with microsatellite instability-high/mismatch repair-deficient tumors. (PubMed, Clin Cancer Res)
    LY3300054 monotherapy and combined LY3300054/anti-TIM-3 had manageable safety profiles. Both regimens showed promising clinical activity against PD-1/PD-L1 inhibitor-naïve MSI-H/dMMR tumors. The combination had limited clinical benefit in patients with PD-1/PD-L1 inhibitor-resistant/refractory MSI‑H/dMMR tumors.
    Clinical • Journal • Combination therapy • Mismatch repair • Microsatellite instability
    |
    MSI (Microsatellite instability) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    MSI-H/dMMR
    |
    lodapolimab (LY3300054) • LY3321367
    over3years
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=215, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2021 --> Dec 2022
    Trial completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    almost4years
    Blocking TIM-3 in Treatment-Refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody. (PubMed, Clin Cancer Res)
    LY3321367 exhibited acceptable safety profile with favorable PK/PD but only modest antitumor activity. The therapeutic relevance of TIM-3 blockade requires further investigation.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    LY3321367
    over4years
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=215, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367
    almost5years
    A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=215, Recruiting, Eli Lilly and Company | Trial completion date: Apr 2022 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Jun 2020
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • Cyramza (ramucirumab) • merestinib (LY2801653) • lodapolimab (LY3300054) • LY3321367