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    DRUG:

    eribulin liposomal (E7389-LF)

    i
    Other names: E7389-LF, E7389 liposomal
    Company:
    Eisai, Ono Pharma
    Drug class:
    Microtubule inhibitor
    Related drugs:
    12d
    A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor (clinicaltrials.gov)
    P1/2, N=125, Active, not recruiting, Eisai Co., Ltd. | Phase classification: P1b/2 --> P1/2 | Trial completion date: Jan 2024 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026
    Phase classification • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • eribulin liposomal (E7389-LF)
    2ms
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2025 --> Mar 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    10ms
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2024 --> Aug 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    11ms
    Phase 2 Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort. (PubMed, Clin Cancer Res)
    Promising antitumor activity was observed with E7389-LF in combination with nivolumab in patients with GC, and no new safety signals were observed, compared with either monotherapy.
    P2 data • Journal • Combination therapy • PD(L)-1 Biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CD8 positive
    |
    Opdivo (nivolumab) • Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over1year
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    over1year
    E7389-LF as a first-line (1L) chemotherapy for patients (pts) with metastatic/advanced HER2-negative breast cancer (HER2− BC): Results from a phase I study dose-expansion part (ESMO 2023)
    Changes in vasculature- and IFNγ-related serum markers were noted. Conclusions E7389-LF showed promising efficacy and a manageable toxicity profile and should be explored as a 1L treatment option for pts with advanced HER2− BC.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma)
    |
    HR positive • HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    over1year
    Phase Ib/II Study of a Liposomal Formulation of Eribulin (E7389-LF) plus Nivolumab in Patients with Advanced Solid Tumors: Results from Phase Ib. (PubMed, Cancer Res Commun)
    The combination was tolerable overall; 4 patients had a partial response. Vasculature and immune-related biomarker levels increased, suggesting vascular remodeling.
    P1/2 data • Clinical Trial,Phase I • Journal • PD(L)-1 Biomarker • Metastases
    |
    Opdivo (nivolumab) • Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over1year
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2023 --> Mar 2024 | Trial primary completion date: Apr 2023 --> Mar 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    over2years
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Eisai Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    over2years
    Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the breast cancer expansion cohort. (PubMed, Eur J Cancer)
    E7389-LF was tolerable and favourable antitumour activity was observed, particularly in patients with HR+ BC. Prophylactic pegfilgrastim can be considered in patients at high risk for neutropenia and febrile neutropenia.
    P1 data • Clinical Trial,Phase I • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF) • Neulasta (pegfilgrastim)
    over2years
    Phase 1 Dose Escalation Study of the Liposomal Formulation of Eribulin (E7389-LF) in Japanese Patients with Advanced Solid Tumors. (PubMed, Clin Cancer Res)
    E7389-LF was well-tolerated at 2.0 mg/m Q3W and 1.5 mg/m Q2W. Considering the toxicity profile of both regimens, the recommended dose was 2.0 mg/m Q3W. Expansion cohorts are ongoing.
    P1 data • Clinical Trial,Phase I • Journal
    |
    IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • FLT4 (Fms-related tyrosine kinase 4) • ICAM1 (Intercellular adhesion molecule 1) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • CD31 (Platelet and endothelial cell adhesion molecule 1)
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    3years
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Recruiting, Eisai Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Apr 2021 --> Aug 2023 | Trial primary completion date: Nov 2020 --> Feb 2023
    Clinical • Enrollment open • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over3years
    Quantitative Multiplex Immunofluorescence evaluation of the tumor microenvironment in pretreatment tumors of patients with metastatic breast cancer and serous ovarian carcinoma treated with liposomal eribulin. (PubMed, Cancer Invest)
    Greater density of CD3+ (p = 0.01) and CD3 + CD8+ (p = 0.03) cells and closer proximity between CD3 + CD8+ and tumor cells was observed in the patients with disease control (PR + SD) vs. progressive disease. QmIF identified an association between TIL infiltration and eribulin-LF sensitivity, which should evaluated further in prospective studies.
    Clinical • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over4years
    Study of E7389 Liposomal Formulation in Subjects With Solid Tumor (clinicaltrials.gov)
    P1, N=116, Active, not recruiting, Eisai Co., Ltd. | Trial primary completion date: Aug 2020 --> Nov 2020
    Clinical • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over4years
    Study of E7389 Liposomal Formulation in Subjects With Solid Tumor (clinicaltrials.gov)
    P1, N=125, Active, not recruiting, Eisai Co., Ltd. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over4years
    [VIRTUAL] Phase I study of the liposomal formulation of eribulin (E7389-LF): Results from the HER2-negative breast cancer expansion (ESMO 2020)
    Funding: Eisai Co., Ltd., Tokyo, Japan. Clinical trial identification: NCT03207672.
    P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    over4years
    Study of E7389 Liposomal Formulation in Subjects With Solid Tumor (clinicaltrials.gov)
    P1, N=125, Recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2020 --> Apr 2021
    Clinical • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    almost5years
    Study of E7389 Liposomal Formulation in Subjects With Solid Tumor (clinicaltrials.gov)
    P1, N=125, Recruiting, Eisai Co., Ltd. | Trial completion date: Apr 2021 --> Aug 2020 | Trial primary completion date: Mar 2020 --> Aug 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)
    almost5years
    Study of E7389 Liposomal Formulation in Subjects With Solid Tumor (clinicaltrials.gov)
    P1, N=125, Recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2020 --> Apr 2021 | Trial primary completion date: Dec 2019 --> Mar 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Halaven (eribulin mesylate) • eribulin liposomal (E7389-LF)