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    DRUG:

    Halaven (eribulin mesylate)

    i
    Other names: E7389, ER-086526, B1939 mesylate, B-1939, Halichondrin B analog, NSC-707389
    Company:
    Eisai, Knight Therap, Shenzhen Kexing Pharma
    Drug class:
    Microtubule inhibitor, CBP inhibitor, β-catenin inhibitor
    Related drugs:
    6d
    Pathological complete response to pembrolizumab in recurrent retroperitoneal dedifferentiated liposarcoma with high tumor mutational burden: a case report. (PubMed, World J Surg Oncol)
    This is the first reported case of recurrent retroperitoneal DDLPS with high TMB achieving pCR to pembrolizumab. High TMB and high TAM density in the tumor microenvironment may be predictive biomarkers for the response to ICIs in DDLPS.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • TMB-H • PD-L1 negative
    |
    Keytruda (pembrolizumab) • doxorubicin hydrochloride • pazopanib • Halaven (eribulin mesylate)
    6d
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=792, Recruiting, Hoffmann-La Roche | N=580 --> 792 | Trial completion date: May 2028 --> Sep 2030 | Trial primary completion date: May 2028 --> Sep 2030
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PD-L1 expression • PIK3CA mutation
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • atirmociclib (PF-07220060) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    13d
    A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors. (clinicaltrials.gov)
    P2, N=95, Recruiting, Fudan University | Not yet recruiting --> Recruiting | Phase classification: PN/A --> P2 | N=66 --> 95 | Trial completion date: May 2028 --> Dec 2028 | Initiation date: Apr 2025 --> Nov 2025 | Trial primary completion date: Jul 2026 --> Dec 2027
    Enrollment open • Phase classification • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date
    |
    Halaven (eribulin mesylate)
    14d
    ESPERO: Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2026 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 positive • HER-2 expression
    |
    Halaven (eribulin mesylate) • Ontruzant (trastuzumab-dttb)
    16d
    DESTINY Breast Respond HER2-low Europe (clinicaltrials.gov)
    P=N/A, N=1155, Recruiting, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Trial primary completion date: Jun 2027 --> Sep 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 underexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate)
    17d
    BL-B01D1-307: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=418, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    20d
    ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=558, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carboplatin • gemcitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • pumitamig (BNT327)
    23d
    Predicting the Efficacy of Eribulin in Metastatic Breast Cancer by Assessing E-Cadherin and Vimentin Expression. (PubMed, Acta Histochem Cytochem)
    Altered E-cadherin and/or vimentin expression was more frequently observed in responders (p = 0.013) and associated with longer progression-free survival (p = 0.048). These results suggest that eribulin efficacy may be predicted by altered E-cadherin and vimentin expression before treatment.
    Journal
    |
    CDH1 (Cadherin 1) • VIM (Vimentin)
    |
    Halaven (eribulin mesylate)
    24d
    A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=48, Recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1
    Phase classification
    |
    temozolomide • irinotecan • Halaven (eribulin mesylate)
    30d
    Targeting Interleukin-6 as a Novel Strategy to Overcome Eribulin Resistance in Breast Cancer. (PubMed, Cancer Med)
    These findings suggest that IL-6 contributes to eribulin resistance in breast cancer and that IL-6 receptor inhibition is a promising therapeutic strategy to overcome this resistance.
    Journal
    |
    IL6 (Interleukin 6)
    |
    doxorubicin hydrochloride • Halaven (eribulin mesylate) • Actemra IV (tocilizumab)
    1m
    A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) (clinicaltrials.gov)
    P3, N=644, Active, not recruiting, AstraZeneca | Trial primary completion date: Dec 2025 --> Aug 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    PD-L1 expression • PD-L1 negative
    |
    carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • Datroway (datopotamab deruxtecan-dlnk)
    1m
    Efficacy and Safety of Epalolitovorellizumab in Combination with Eribulin as Second-line and Later-line Therapy for Patients with Advanced Triple-negative Breast Cancer (ChiCTR2500111069)
    P4, N=49, Not yet recruiting, Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    Halaven (eribulin mesylate)