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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.

Publication ,  Journal Article
Zandberg, DP; Algazi, AP; Jimeno, A; Good, JS; Fayette, J; Bouganim, N; Ready, NE; Clement, PM; Even, C; Jang, RW; Wong, S; Keilholz, U ...
Published in: Eur J Cancer
January 2019

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.

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Published In

Eur J Cancer

DOI

EISSN

1879-0852

Publication Date

January 2019

Volume

107

Start / End Page

142 / 152

Location

England

Related Subject Headings

  • Young Adult
  • Survival Rate
  • Squamous Cell Carcinoma of Head and Neck
  • Salvage Therapy
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Lymphatic Metastasis
 

Citation

APA
Chicago
ICMJE
MLA
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Zandberg, D. P., Algazi, A. P., Jimeno, A., Good, J. S., Fayette, J., Bouganim, N., … 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. Eur J Cancer, 107, 142–152. https://doi.org/10.1016/j.ejca.2018.11.015
Zandberg, Dan P., Alain P. Algazi, Antonio Jimeno, James S. Good, Jérôme Fayette, Nathaniel Bouganim, Neal E. Ready, et al. “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.Eur J Cancer 107 (January 2019): 142–52. https://doi.org/10.1016/j.ejca.2018.11.015.
Zandberg DP, Algazi AP, Jimeno A, Good JS, Fayette J, Bouganim N, Ready NE, Clement PM, Even C, Jang RW, Wong S, Keilholz U, Gilbert J, Fenton M, Braña I, Henry S, Remenar E, Papai Z, Siu LL, Jarkowski A, Armstrong JM, Asubonteng K, Fan J, Melillo G, Mesía R. 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. Eur J Cancer. 2019 Jan;107:142–152.
Journal cover image

Published In

Eur J Cancer

DOI

EISSN

1879-0852

Publication Date

January 2019

Volume

107

Start / End Page

142 / 152

Location

England

Related Subject Headings

  • Young Adult
  • Survival Rate
  • Squamous Cell Carcinoma of Head and Neck
  • Salvage Therapy
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Lymphatic Metastasis