^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    xentuzumab (BI-836845)

    i
    Other names: BI-836845, BI836845, BI 836845
    Company:
    Boehringer Ingelheim, Novartis
    Drug class:
    IGF-2 inhibitor, IGF1 inhibitor
    1m
    Phase Ib study of xentuzumab and abemaciclib in patients with advanced solid tumors and in combination with endocrine therapy in patients with advanced breast cancer. (PubMed, ESMO Open)
    Xentuzumab + abemaciclib + ETs demonstrated manageable tolerability and promising efficacy, especially in patients with breast cancer and non-visceral metastases.
    P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCND1 (Cyclin D1) • MCL1 (Myeloid cell leukemia 1) • IGF1 (Insulin-like growth factor 1)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • xentuzumab (BI-836845)
    3ms
    Artificial intelligence and radiomics biomarkers for treatment response prediction in advanced HER2-negative breast cancer. (PubMed, Breast)
    This cross-cancer proof-of-concept testing study supports the feasibility of applying multimodal AI/radiomics biomarkers to predict treatment response in advanced HR+, HER2- breast cancer, laying the foundation for broader pancancer and pantreatment applications pending further validation.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    everolimus • exemestane • xentuzumab (BI-836845)
    10ms
    WINGMEN: IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy (clinicaltrials.gov)
    P1, N=27, Completed, University of Oxford | Active, not recruiting --> Completed
    Trial completion
    |
    xentuzumab (BI-836845)
    over1year
    This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer (clinicaltrials.gov)
    P1, N=133, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor)
    |
    Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • xentuzumab (BI-836845)
    almost2years
    This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer. (clinicaltrials.gov)
    P1, N=133, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Dec 2023 --> Apr 2024
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor)
    |
    EGFR mutation • HER-2 negative • ALK translocation
    |
    Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • xentuzumab (BI-836845)
    2years
    A Phase Ib/II study of IGF-neutralising antibody xentuzumab with enzalutamide in metastatic castration-resistant prostate cancer. (PubMed, Br J Cancer)
    Xentuzumab plus enzalutamide was tolerable but lacked antitumour activity in unselected patients with mCRPC.
    P1/2 data • Clinical Trial,Phase II • Journal • Metastases
    |
    PTEN (Phosphatase and tensin homolog) • IGF1 (Insulin-like growth factor 1)
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • xentuzumab (BI-836845)
    over2years
    This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer. (clinicaltrials.gov)
    P1, N=133, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Aug 2023 --> Dec 2023
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor)
    |
    EGFR mutation • HER-2 negative • ALK translocation
    |
    Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • xentuzumab (BI-836845)
    over2years
    XENERA-1: a randomised double-blind Phase II trial of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in patients with hormone receptor-positive/HER2-negative metastatic breast cancer and non-visceral disease. (PubMed, Breast Cancer Res)
    While this study demonstrated that xentuzumab could be safely combined with everolimus and exemestane in patients with HR-positive/HER2-negative advanced breast cancer with non-visceral disease, there was no PFS benefit with the addition of xentuzumab. Trial registration ClinicalTrials.gov, NCT03659136. Prospectively registered, September 6, 2018.
    P2 data • Journal • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • IGF1 (Insulin-like growth factor 1) • IGF2 (Insulin-like growth factor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    everolimus • exemestane • xentuzumab (BI-836845)
    over2years
    Identification of IGF2 as Genomic Driver and Actionable Therapeutic Target in Hepatoblastoma. (PubMed, Mol Cancer Ther)
    The antitumor effect of xentuzumab (a monoclonal antibody targeting IGF1/2) alone or in combination with the conventional therapeutic agent cisplatin was assessed in HB cell lines, in PDX-derived HB organoids and in a xenograft HB murine model. These results suggest that IGF2 is an HB actionable driver and that, in preclinical models of HB, the combination of IGF1/2 inhibition with cisplatin induces superior antitumor effects than cisplatin monotherapy. Overall, our study provides a rationale for testing IGF2 inhibitors in combination with cisplatin in HB patients with IGF2 overexpression.
    Journal
    |
    IGF1 (Insulin-like growth factor 1) • IGF2 (Insulin-like growth factor 2) • MIR483 (MicroRNA 483)
    |
    IGF2 overexpression
    |
    cisplatin • xentuzumab (BI-836845)
    over3years
    The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread (clinicaltrials.gov)
    P2, N=103, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR positive
    |
    everolimus • exemestane • xentuzumab (BI-836845)
    almost4years
    BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=164, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    everolimus • exemestane • xentuzumab (BI-836845)