Durvalumab for recurrent or metastatic head and neck squamous cell carcinoma: Results from a single-arm, phase II study in patients with ≥25% tumour cell PD-L1 expression who have progressed on platinum-based chemotherapy

Dan P. Zandberg, Alain P. Algazi, Antonio Jimeno, James S. Good, Jérôme Fayette, Nathaniel Bouganim, Neal E. Ready, Paul M. Clement, Caroline Even, Raymond W. Jang, Stuart Wong, Ulrich Keilholz, Jill Gilbert, Moon Fenton, Irene Braña, Stephanie Henry, Eva Remenar, Zsuzsanna Papai, Lillian L. Siu, Anthony JarkowskiJon M. Armstrong, Kobby Asubonteng, Jean Fan, Giovanni Melillo, Ricard Mesía

Research output: Article

35 Citations (Scopus)

Abstract

Background: Patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) progressing on platinum-based chemotherapy have poor prognoses and limited therapeutic options. Programmed cell death-1 (PD-1) and its ligand 1 (PD-L1) are frequently upregulated in HNSCC. The international, multi-institutional, single-arm, phase II HAWK study (NCT02207530) evaluated durvalumab monotherapy, an anti-PD-L1 monoclonal antibody, in PD-L1-high patients with platinum-refractory R/M HNSCC. Patients and methods: Immunotherapy-naïve patients with confirmed PD-L1-high tumour cell expression (defined as patients with ≥25% of tumour cells expressing PD-L1 [TC ≥ 25%] using the VENTANA PD-L1 [SP263] Assay) received durvalumab 10 mg/kg intravenously every 2 weeks for up to 12 months. The primary end-point was objective response rate; secondary end-points included progression-free survival (PFS) and overall survival (OS). Results: Among evaluable patients (n = 111), objective response rate was 16.2% (95% confidence interval [CI], 9.9–24.4); 29.4% (95% CI, 15.1–47.5) for human papillomavirus (HPV)-positive patients and 10.9% (95% CI, 4.5–21.3) for HPV-negative patients. Median PFS and OS for treated patients (n = 112) was 2.1 months (95% CI, 1.9–3.7) and 7.1 months (95% CI, 4.9–9.9); PFS and OS at 12 months were 14.6% (95% CI, 8.5–22.1) and 33.6% (95% CI, 24.8–42.7). Treatment-related adverse events were 57.1% (any grade) and 8.0% (grade ≥3); none led to death. At data cut-off, 24.1% of patients remained on treatment or in follow-up. Conclusion: Durvalumab demonstrated antitumour activity with acceptable safety in PD-L1-high patients with R/M HNSCC, supporting its ongoing evaluation in phase III trials in first- and second-line settings. In an ad hoc analysis, HPV-positive patients had a numerically higher response rate and survival than HPV-negative patients.

Original languageEnglish
Pages (from-to)142-152
Number of pages11
JournalEuropean Journal of Cancer
Volume107
DOIs
Publication statusPublished - jan. 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Zandberg, D. P., Algazi, A. P., Jimeno, A., Good, J. S., Fayette, J., Bouganim, N., Ready, N. E., Clement, P. M., Even, C., Jang, R. W., Wong, S., Keilholz, U., Gilbert, J., Fenton, M., Braña, I., Henry, S., Remenar, E., Papai, Z., Siu, L. L., ... Mesía, R. (2019). Durvalumab for recurrent or metastatic head and neck squamous cell carcinoma: Results from a single-arm, phase II study in patients with ≥25% tumour cell PD-L1 expression who have progressed on platinum-based chemotherapy. European Journal of Cancer, 107, 142-152. https://doi.org/10.1016/j.ejca.2018.11.015