Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study

Martin D. Forster, Magnus T. Dillon, Judit Kocsis, Éva Remenár, Gabor Pajkos, Frederic Rolland, Jonathan Greenberg, Kevin J. Harrington

Research output: Contribution to journalArticle

Abstract

Background: The fully human monoclonal antibody patritumab blocks HER3 activation, a resistance mechanism to cetuximab, induced by heregulin (HRG). A phase Ib study in recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) demonstrated tolerability and tumour response of patritumab + cetuximab + platinum. Methods: This was a randomised, double-blind, phase II study of patritumab + cetuximab with platinum-based therapy for first-line treatment of R/M SCCHN (Clinicaltrials.gov identifier: NCT02633800). Patients aged ≥18 years received patritumab or placebo, both combined with cetuximab + cisplatin or carboplatin. Co-primary end-points were progression-free survival (PFS) in the intent-to-treat (ITT) and the high-expression HRG (HRG high) populations. Results: Eighty-seven patients (n = 43 in the patritumab group; n = 44 in placebo group) enrolled. A median (range) of 6.5 (1–24) patritumab cycles were completed. Median PFS was similar between the patritumab group and placebo group in the ITT population (5.6 versus 5.5 months; hazard ratio [HR] 0.99 [95% confidence interval [CI], 0.6–1.7]; P = 0.96) and HRG-high subgroup (n = 51; 5.6 versus 5.6 months; HR 0.93 [95% CI, 0.5–1.8]; P = 0.82). Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69–2.29]; P = 0.46). All patients experienced ≥1 treatment-emergent adverse event (TEAE). Grade ≥III TEAEs were more frequent in the patritumab than the placebo group (84.1% versus 60.5%). The most common grade ≥III patritumab-related TEAE in the patritumab group (20.5% overall) was rash (6.8%). Conclusion: Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum.

Original languageEnglish
Pages (from-to)36-47
Number of pages12
JournalEuropean Journal of Cancer
Volume123
DOIs
Publication statusPublished - Dec 2019

Keywords

  • Cetuximab
  • Clinical trial
  • Heregulin
  • Metastatic
  • Patritumab
  • Phase II
  • Recurrence
  • Squamous cell carcinoma of the head and neck

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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