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    DRUG:

    farletuzumab ecteribulin (MORAb-202)

    i
    Other names: MORAb-202, MORAb 202, MORAB-202, MORAB202
    Company:
    Eisai
    Drug class:
    Microtubule inhibitor, Folate receptor 1-targeted antibody-drug conjugate
    Related drugs:
    2ms
    CA116-001: A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=106, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Sep 2025
    Trial completion • Trial completion date • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    paclitaxel • pegylated liposomal doxorubicin • topotecan • farletuzumab ecteribulin (MORAb-202)
    2ms
    MORAb-202-G000-201: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types (clinicaltrials.gov)
    P1/2, N=182, Recruiting, Eisai Inc. | Trial completion date: Dec 2024 --> Aug 2030 | Trial primary completion date: Dec 2024 --> Aug 2030
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 negative
    |
    Lenvima (lenvatinib) • prednisone • farletuzumab ecteribulin (MORAb-202) • prednisolone
    3ms
    A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) (clinicaltrials.gov)
    P2, N=31, Terminated, Bristol-Myers Squibb | N=50 --> 31
    Enrollment change
    |
    farletuzumab ecteribulin (MORAb-202)
    4ms
    Comprehensive assessments of pharmacokinetics and immunogenicity of farletuzumab ecteribulin, a novel antibody-drug conjugate against tumors expressing folate receptor α, in monkeys. (PubMed, J Pharm Biomed Anal)
    Following intravenous administration, the PK profiles of Tab and ADC were similar, while minimal levels of eribulin. No ADA against MORAb-202 was detected in postdose samples.
    PK/PD data • Journal
    |
    FOLR1 ( Folate receptor alpha )
    |
    Halaven (eribulin mesylate) • farletuzumab ecteribulin (MORAb-202)
    6ms
    Antitumor Effect of Farletuzumab ecteribulin in Molecular Subtypes of Endometrial Cancer Patient-Derived Xenograft Models. (PubMed, Mol Cancer Ther)
    Notably, intratumoral eribulin accumulation exhibited a stronger correlation with efficacy than with FRα expression alone. These findings support further clinical development of FZEC for EC treatment and highlight the complexity of the mechanisms of action of ADCs.
    Preclinical • Journal
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    Halaven (eribulin mesylate) • farletuzumab ecteribulin (MORAb-202)
    1year
    CA116-001: A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FOLR1 ( Folate receptor alpha )
    |
    paclitaxel • pegylated liposomal doxorubicin • topotecan • farletuzumab ecteribulin (MORAb-202)
    1year
    The Efficacy and Safety of Folate Receptor α-Targeted Antibody-Drug Conjugate Therapy in Patients With High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers: A Systematic Review and Meta-Analysis. (PubMed, Cancer Med)
    FRα-targeting ADCs, including MIRV, demonstrated definite efficacy and good safety as novel choices for second-line and beyond treatment of advanced or recurrent ovarian cancer. Patients with high FRα expression showed ORR and PFS benefits similar to those in the overall cohort.
    Clinical • Retrospective data • Review • Journal
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    Halaven (eribulin mesylate) • Elahere (mirvetuximab soravtansine-gynx) • luveltamab tazevibulin (STRO-002) • farletuzumab ecteribulin (MORAb-202)
    1year
    A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) (clinicaltrials.gov)
    P2, N=50, Terminated, Bristol-Myers Squibb | Trial completion date: Feb 2026 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Aug 2024; Business objectives have changed
    Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    farletuzumab ecteribulin (MORAb-202)
    1year
    MORAb-202-G000-201: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types (clinicaltrials.gov)
    P1/2, N=142, Recruiting, Eisai Inc. | Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Mar 2025 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 negative • PGR negative
    |
    prednisone • farletuzumab ecteribulin (MORAb-202) • prednisolone
    2years
    MORAb-202-G000-201: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types (clinicaltrials.gov)
    P1/2, N=142, Recruiting, Eisai Inc. | N=66 --> 142
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FOLR1 ( Folate receptor alpha )
    |
    HER-2 negative • PGR negative
    |
    prednisone • farletuzumab ecteribulin (MORAb-202) • prednisolone
    over2years
    Antitumor activity of farletuzumab ecteribulin in a panel of endometrial cancer patient-derived xenografts with four different molecular subtypes (ESMO 2023)
    Intratumoral imaging analysis using tumors on day 21st showed an association between the antitumor effect and intratumoral accumulation of eribulin. Conclusions These results suggest that FZEC may be a promising treatment for FRα-expressing EC of all four molecular subtypes.
    Clinical • MSi-H Biomarker
    |
    MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • FOLR1 ( Folate receptor alpha )
    |
    MSI-H/dMMR • POLE mutation • FOLR1 expression
    |
    Halaven (eribulin mesylate) • farletuzumab ecteribulin (MORAb-202)