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    DRUG:

    lodapolimab (LY3300054)

    i
    Other names: LY3300054, LY 3300054, LY330
    Company:
    Eli Lilly
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    19d
    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
    5ms
    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
    7ms
    A Study of LY3200882 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=223, Active, not recruiting, Eli Lilly and Company | Trial completion date: Aug 2023 --> Aug 2024
    Trial completion date
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • lodapolimab (LY3300054) • LY3200882
    7ms
    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
    over1year
    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
    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
    almost3years
    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
    3years
    A Phase I Study of an IDO-1 Inhibitor (LY3381916) as Monotherapy and in Combination With an Anti-PD-L1 Antibody (LY3300054) in Patients With Advanced Cancer. (PubMed, J Immunother)
    These preliminary data suggest an alternative dose level of LY3381916 is needed for the combination with PD-L1 inhibitor. The combination clinical activity was limited in this study.
    Clinical • P1 data • Journal • Combination therapy
    |
    CD8 (cluster of differentiation 8) • IDO1 (Indoleamine 2,3-dioxygenase 1)
    |
    lodapolimab (LY3300054) • LY3381916
    3years
    Immune modulating activity of the CHK1 inhibitor prexasertib and anti-PD-L1 antibody LY3300054 in patients with high-grade serous ovarian cancer and other solid tumors. (PubMed, Cancer Immunol Immunother)
    Prexasertib in combination with PD-L1 blockade was tolerable and demonstrated preliminary activity in CCNE1-amplified HGSOC with evidence of cytotoxic T-cell activation in patient blood samples.
    Clinical • Journal
    |
    CD8 (cluster of differentiation 8) • CCNE1 (Cyclin E1)
    |
    CCNE1 amplification
    |
    prexasertib (ACR-368) • lodapolimab (LY3300054)
    3years
    A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=17, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Apr 2024 --> Feb 2021
    Clinical • Trial completion • Trial completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    prexasertib (ACR-368) • lodapolimab (LY3300054)
    almost4years
    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
    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, 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
    over4years
    A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | N=28 --> 17
    Clinical • Enrollment closed • Enrollment change • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    prexasertib (ACR-368) • lodapolimab (LY3300054)
    over4years
    A phase I study of an anti-IDO1 inhibitor (LY3381916) as monotherapy and in combination with an anti-PD-L1 antibody (LY3300054) in patients with advanced cancer (ESMO-IO 2019)
    LY3381916 is safely administered as monotherapy and in combination with LY3300054. The 240mg dose QD is the RP2D for combination with PD-L1 in expansion cohorts.Legal entity responsible for the study: Eli Lilly and Company. Funding: Eli Lilly and Company.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IDO1 (Indoleamine 2,3-dioxygenase 1)
    |
    lodapolimab (LY3300054) • LY3381916