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Title: 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
Author: Zandberg, Dan P.
Algazi, Alain P.
Jimeno, Antonio
Good, James S.
Fayette, Jérôme
Bouganim, Nathaniel
Ready, Neal E.
Clement, Paul M.
Even, Caroline
Jang, Raymond W.
Wong, Stuart
Keilholz, Ulrich
Gilbert, Jill
Fenton, Moon
Brana, Irene
Henry, Stephanie
Remenar, Eva
Papai, Zsuzsanna
Siu, Lillian L.
Jarkowski, Anthony
Armstrong, Jon M.
Asubonteng, Kobby
Fan, Jean
Melillo, Giovanni
Mesía Nin, Ricard
Keywords: Càncer de cap
Càncer de coll
Head cancer
Neck cancer
Issue Date: 1-Jan-2019
Publisher: Elsevier Science Ltd
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-naive 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. (C) 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (
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It is part of: European Journal of Cancer, 2019, vol. 107, p. 142-152
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Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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