ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023
Safety and Efficacy of MEDI0457 plus Durvalumab in Patients with Human Papillomavirus-Associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.
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Who cites it
40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Immunotherapy plus targeted therapy for recurrent or metastatic head and neck squamous cell carcinoma: an updated meta-analysis and subgroup analysis by target mechanism.Frontiers in oncology · 2026Pooled it
- Outcomes for recurrent or metastatic head and neck cancer by HPV status: a systematic review and meta-analysis.The oncologist · 2025Pooled it
- Oropharyngeal cancer and human papillomavirus: a visualization based on bibliometric analysis and topic modeling.Frontiers in microbiology · 2024Pooled it
- DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107.Nature communications · 2025Trial
- Safety, tolerability, and immunogenicity of a DNA-based vaccine (INO-4700) against Middle East respiratory syndrome coronavirus: phase 2a study in healthy volunteers.Frontiers in immunology · 2025Trial
- ISA101 and nivolumab for HPV-16Journal for immunotherapy of cancer · 2022Trial
- Impact of PD-1 Inhibitor Timing Relative to Locoregional Therapy on Outcomes in uHCC Treated With Lenvatinib-Based Triple Therapy.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- A calreticulin-linked HPV-16 E7 minigene DNA vaccine elicits strong E7-specific CD8+ T-cell immunity and durable antitumor effects in a preclinical model.Scientific reports · 2026Article
- Personalized and HPV cancer vaccines in head and neck squamous cell carcinoma: from concept to clinical implementation.Translational oncology · 2026Review
- Therapeutic Vaccines for Head and Neck Squamous Cell Carcinoma and Nasopharyngeal Carcinoma.Vaccines · 2026Review
- Precision immunotherapy for head and neck cancer: therapeutic combinations, biomarker strategies, and translational challenges.Molecular cancer · 2026Review
- Synthetic consensus DNA vaccines against Merkel cell polyomavirus large and small T antigens induce robust polyfunctional T cell responses.Frontiers in immunology · 2026Article
- Head and neck cancer therapeutic vaccines: a review.Frontiers in oncology · 2026Review
- Advances in immunotherapy for HPV-associated malignancies: emerging strategies and clinical progress.Frontiers in immunology · 2026Review
- Shaping next decade of systemic therapy for head and neck squamous cell carcinoma: where do we go next?Frontiers in oncology · 2026Review
- Trends in immunotherapy for oral squamous cell carcinoma.Cellular oncology (Dordrecht, Netherlands) · 2025Review
- Article
- DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Update: Immunotherapeutic Strategies in HPV-Associated Head and Neck Squamous Cell Carcinoma.Viruses · 2025Review
- Immunotherapeutic strategies in head and neck cancer: challenges and opportunities.The Journal of clinical investigation · 2025Review
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Authors and funding
20 authors at 13 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTumoral programmed cell death ligand-1 (PD-L1) expression is common in human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC). We assessed whether a DNA vaccine targeting HPV-16/18 E6/E7 with IL12 adjuvant (MEDI0457) combined with the PD-L1 inhibitor durvalumab could enhance HPV-specific T-cell response and improve outcomes in recurrent/metastatic HPV-16/18-associated HNSCC. PATIENTS AND
methodsIn this phase Ib/IIa study, immunotherapy-naïve patients with ≥1 previous platinum-containing regimen (neoadjuvant/adjuvant therapy or for recurrent/metastatic disease) received MEDI0457 7 mg intramuscularly with electroporation on weeks 1, 3, 7, and 12, then every 8 weeks, plus durvalumab 1,500 mg intravenously on weeks 4, 8, and 12, then every 4 weeks, until confirmed progression and/or unacceptable toxicity. Coprimary objectives were safety and objective response rate (ORR; H0: ORR ≤ 15%); secondary objectives included 16-week disease control rate (DCR-16), overall survival (OS), and progression-free survival (PFS).
resultsOf 35 treated patients, 29 were response evaluable (confirmed HPV-associated disease; received both agents). ORR was 27.6% [95% confidence interval (CI), 12.7-47.2; four complete responses, four partial responses]; responses were independent of PD-L1 tumor-cell expression (≥25% vs. <25%). DCR-16 was 44.8% (95% CI, 26.5-64.3). Median PFS was 3.5 months (95% CI, 1.9-9.0); median OS was 29.2 months (15.2-not calculable). Twenty-eight (80.0%) patients had treatment-related adverse events [grade 3: 5 (14.3%); no grade 4/5], resulting in discontinuation in 2 (5.7%) patients. HPV-16/18-specific T cells increased on treatment; 4 of 8 evaluable patients had a >2-fold increase in tumor-infiltrating CD8+ T cells.
conclusionsMEDI0457 plus durvalumab was well tolerated. While the primary efficacy endpoint was not reached, clinical benefit was encouraging.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.