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Mini Oral - Head & neck cancer

916MO - 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)


18 Sep 2020


Mini Oral - Head & neck cancer



Tumour Site

Head and Neck Cancers


Charu Aggarwal


Annals of Oncology (2020) 31 (suppl_4): S599-S628. 10.1016/annonc/annonc277


C. Aggarwal1, N.F. Saba2, A.P. Algazi3, A. Sukari4, T. Seiwert5, M. Haigentz6, M. Porosnicu7, M. Bonomi8, J. Boyer9, N. Durham10, R. Kumar11, K. Laubscher11, M. Gong12, N. Ceaicovscaia13, A. Gascó Hernández13

Author affiliations

  • 1 Hematology/oncology, Raymond and Ruth Perelman School of Medicine, Abramson Cancer Center, University of Pennsylvania, 19104 - Philadelphia/US
  • 2 Hematology & Medical Oncology, Emory University, Atlanta/US
  • 3 Hematology And Oncology, University of California San Francisco, San Francisco/US
  • 4 Karmanos Cancer Institute, Wayne State University, Detroit/US
  • 5 Head And Neck Cancer Oncology Disease Group, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore/US
  • 6 N/a, Atlantic Health System, Morristown Medical Center, Morristown/US
  • 7 Department Of Medicine, Section Of Hematology/oncology, Wake Forest School of Medicine, Winston-Salem/US
  • 8 Medical Oncology, Ohio State University, 43210 - Columbus/US
  • 9 Analytical Sciences, Inovio Pharmaceuticals, Philadelphia/US
  • 10 Translational Medicine, AstraZeneca, 20878 - Gaithersburg/US
  • 11 Clinical Operations, AstraZeneca, 20878 - Gaithersburg/US
  • 12 Biometrics, AstraZeneca, 20878 - Gaithersburg/US
  • 13 Early Clinical Development, AstraZeneca, 20878 - Gaithersburg/US


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Abstract 916MO


Immunotherapy targeting programmed death protein 1 (PD-1) or its ligand (PD-L1) offers clinical benefit in HNSCC, but combination treatments are needed to improve outcomes. Here we report initial safety and efficacy of the anti-PD-L1 durvalumab plus MEDI0457, a DNA immunotherapeutic vaccine expressing HPV 16/18 E6/E7 proteins and IL-12, in pts with HPV+ R/M HNSCC.


This phase Ib/IIa, open-label, multicenter study (NCT03162224) enrolled pts with incurable, histologically/cytologically confirmed R/M HPV+ HNSCC, who had ≥1 prior platinum-containing regimen or other approved therapy if platinum-ineligible. MEDI0457 at a dose of 7 mg IM (weeks 1, 3, 7, then Q8W after week 12) and durvalumab 1500 mg IV Q4W were given until disease progression or unacceptable toxicity. Primary objectives included safety and efficacy by objective response rate (ORR; RECIST v1.1). Exploratory endpoints included induction of antibodies and HPV-specific T cells peripherally. Tumor-infiltrating T cells were measured.


In July 2017 to Aug 2019, 35 pts were enrolled. Most were male (97.1%) with oropharyngeal primary (82.9%); 31.4% had PD-L1 ≥25%. At the interim data cutoff (DCO; 22 Nov 2019), therapy was ongoing in 13 pts (37.1%) and 27 were response-evaluable. Treatment-related adverse events (TRAEs) occurred in 77.1% of pts, mostly of Grade 1–2 severity. Fatigue (37.1%) and injection site pain (34.3%) were most common. Five pts (14.3%) had Grade 3 TRAEs and 1 pt (2.9%) had 3 serious Grade 3 TRAEs (AST and ALT increased and myocarditis causing discontinuation). No pts had Grade 4/5 TRAEs. ORR was 22.2% with 3 complete responses (all ongoing at DCO) and 3 partial responses (2 ongoing at DCO). Peripheral HPV-specific T cells and tumoral CD8+ T cells were increased. Table: 916MO

1 prior line of platinum tx for R/M HNSCC (non-refractory) n=12 1 prior line of platinum tx for R/M HNSCC (refractory) n=6 ≥2 prior lines of platinum tx for R/M HNSCC n=9 TotalN=27
Best overall response, n
CR 3 0 0 3
PR 1 0 2 3
SD 2 1 3 6
PD 5 4 4 13
NE 1 1 0 2
ORR (CR or PR), % 33.3 0.0 22.2 22.2


MEDI0457 plus durvalumab was well tolerated and showed clinical benefit. The study is active but not recruiting.

Clinical trial identification


Editorial acknowledgement

Medical writing support was provided by James Holland, PhD, of Cirrus Communications, an Ashfield company, and was funded by AstraZeneca.

Legal entity responsible for the study





C. Aggarwal: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Celgene; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Merck; Advisory/Consultancy: Roche. N.F. Saba: Advisory/Consultancy: Merck; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Rakuten; Advisory/Consultancy: Biontech; Advisory/Consultancy: Aduro; Advisory/Consultancy: Pfizer; Advisory/Consultancy: GlaxoSmithKline. A.P. Algazi: Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options: OncoSec; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Valitor; Honoraria (self), Research grant/Funding (institution): Regeneron; Honoraria (self): Array; Research grant/Funding (institution): Acerta; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Dynavax; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Idera Pharma; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): ISA; Research grant/Funding (institution): Loxo Oncology; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Sensei; Research grant/Funding (institution): Tessa. A. Sukari: Shareholder/Stockholder/Stock options: Immunomedics; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Eisai; Advisory/Consultancy: Bayer; Speaker Bureau/Expert testimony: Merck. T. Seiwert: Advisory/Consultancy: AstraZeneca. M. Haigentz: Advisory/Consultancy: Amgen; Advisory/Consultancy: Genentech; Advisory/Consultancy: Takeda; Advisory/Consultancy: AstraZeneca. M. Porosnicu: Research grant/Funding (institution), I have an investigator initiated clinical trial: AstraZeneca. J. Boyer: Shareholder/Stockholder/Stock options, Full/Part-time employment: Inovio. N. Durham, R. Kumar, K. Laubscher, M. Gong, N. Ceaicovscaia, A. Gascó Hernández: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.

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