Safety and efficacy of durvalumab in patients with head and neck squamous cell carcinoma: results from a phase I/II expansion cohort

Neil H. Segal, Sai Hong I. Ou, Ani Balmanoukian, Matthew G. Fury, Erminia Massarelli, Julie R. Brahmer, Jared Weiss, Patrick Schöffski, Scott J. Antonia, Christophe Massard, Dan P. Zandberg, Samir N. Khleif, Feng Xiao, Marlon C. Rebelatto, Keith E. Steele, Paul B. Robbins, Natasha Angra, Xuyang Song, Shaad Abdullah, Marcus Butler

Research output: Contribution to journalArticlepeer-review

28 Scopus citations


Introduction: Durvalumab selectively blocks programmed cell death ligand-1 (PD-L1) binding to programmed cell death-1. Encouraging clinical activity and manageable safety were reported in urothelial carcinoma, non–small-cell lung cancer (NSCLC), hepatocellular carcinoma (HC) and small-cell lung cancer (SCLC) in a multicenter phase I/II study. Safety and clinical activity in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) were evaluated in the expansion phase. Methods: Patients received 10 mg/kg of durvalumab intravenously every 2 weeks for 12 months or until confirmed progressive disease or unacceptable toxicity. The primary objective was safety; clinical activity was a secondary objective. Results: Sixty-two patients were enrolled and evaluable (received first dose ≥24 weeks before data cutoff). Median age was 57 years; 40.3% were human papillomavirus (HPV)-positive; 32.3% had tumour cell PD-L1 expression ≥25%, and 62.9% were current/former smokers. They had a median of 2 prior systemic treatments (range, 1–13). All-causality adverse events (AEs) occurred in 98.4%; drug-related AEs occurred in 59.7% and were grade III–IV in 9.7%. There were no drug-related discontinuations or deaths. Objective response rate (blinded independent central review) was 6.5% (15.0% for PD-L1 ≥25%, 2.6% for <25%). Median time to response was 2.7 months (range, 1.2–5.5); median duration was 12.4 months (range, 3.5–20.5+). Median progression-free survival was 1.4 months; median overall survival (OS) was 8.4 months. OS rate was 62% at 6 months and 38% at 12 months (42% for PD-L1 ≥25%, 36% for <25%). Conclusions: Durvalumab safety in HNSCC was manageable and consistent with other cohorts of the study. Early, durable responses in these heavily pretreated patients warrant further investigation; phase III monotherapy and combination therapy studies are ongoing. Clinical trial registry: NCT01693562; MedImmune study 1108.

Original languageEnglish (US)
Pages (from-to)154-161
Number of pages8
JournalEuropean Journal of Cancer
StatePublished - Mar 2019


  • Checkpoint inhibition
  • Head and neck squamous cell carcinoma
  • Human papillomavirus
  • Immunotherapy
  • PD-L1

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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