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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
Company:
AstraZeneca, Inovio
Drug class:
HPV-16 E6 protein inhibitor, IL-12 stimulant, HPV-18 E6 protein inhibitor
Associations
10ms
Journal
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Imfinzi (durvalumab) • MEDI0457
10ms
Journal
|
Imfinzi (durvalumab) • MEDI0457
10ms
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
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Imfinzi (durvalumab) • MEDI0457
over1year
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
2years
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)
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Imfinzi (durvalumab) • MEDI0457
almost4years
Clinical
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
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Imfinzi (durvalumab) • MEDI0457
4years
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