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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:
    12ms
    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)
    1year
    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)
    almost2years
    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)
    almost2years
    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)
    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. | 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)
    over2years
    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)
    over2years
    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)
    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. | 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)
    over3years
    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)
    over3years
    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)
    over3years
    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)
    4years
    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)