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    DRUG:

    MEDI0457

    i
    Other names: MEDI0457, MEDI 0457, INO-9012/VGX-3100, MEDI-0457, VGX-3100/INO-9012, INO-3112
    Associations

    News

    Trials
    Company:
    AstraZeneca, Inovio
    Drug class:
    HPV-16 E6 protein inhibitor, IL-12 stimulant, HPV-18 E6 protein inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov)
    P2, N=41, Terminated, M.D. Anderson Cancer Center | N=77 --> 41 | Active, not recruiting --> Terminated; Project delays
    Enrollment change • Trial termination • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Imfinzi (durvalumab) • MEDI0457
    over1year
    MEDI0457 Plus Durvalumab in HPV-associated HNSCC-Response. (PubMed, Clin Cancer Res)
    No abstract available
    Journal
    |
    Imfinzi (durvalumab) • MEDI0457
    over1year
    MEDI0457 Plus Durvalumab in HPV-associated HNSCC-Letter. (PubMed, Clin Cancer Res)
    No abstract available
    Journal
    |
    Imfinzi (durvalumab) • MEDI0457
    over1year
    Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers. (PubMed, Oncologist)
    The combination of MEDI0457 and durvalumab demonstrated acceptable safety and tolerability in patients with advanced HPV-16/18 cancers. The low ORR among patients with cervical cancer led to study discontinuation despite a clinically meaningful disease control rate.
    P2 data • Clinical Trial,Phase II • Journal • Metastases
    |
    Imfinzi (durvalumab) • MEDI0457
    almost2years
    Safety and Efficacy of MEDI0457 Plus Durvalumab in Patients With Human Papillomavirus-associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. (PubMed, Clin Cancer Res)
    MEDI0457 plus durvalumab was well tolerated. While the primary efficacy endpoint was not reached, clinical benefit was encouraging.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • MEDI0457
    almost3years
    DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov)
    P2, N=77, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
    Enrollment closed • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Imfinzi (durvalumab) • MEDI0457
    over4years
    [VIRTUAL] Safety and efficacy of MEDI0457 plus durvalumab in patients (pts) with human papillomavirus-associated recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC) (ESMO 2020)
    Funding: AstraZeneca. Clinical trial identification: NCT03162224.
    Clinical
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
    |
    Imfinzi (durvalumab) • MEDI0457
    over4years
    Immunotherapy targeting HPV 16/18 generates potent immune responses in HPV-Associated Head and Neck Cancer. (PubMed, Clin Cancer Res)
    These data demonstrate that MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. This approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated HNSCCa to improve therapeutic outcomes.
    Journal
    |
    CD8 (cluster of differentiation 8) • FOXP3 (Forkhead Box P3)
    |
    MEDI-547 • MEDI0457