Phase 2, open-label, 1:1 randomized controlled trial exploring the efficacy of EMD 1201081 in combination with cetuximab in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)

A. Ruzsa, M. Sen, M. Evans, L. W. Lee, K. Hideghety, S. Rottey, P. Klimak, P. Holeckova, J. Fayette, T. Csoszi, J. Erfan, U. Forssmann, T. Goddemeier, A. Bexon, C. Nutting

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Aim: to determine whether EMD 1201081, a TLR9 agonist, added to cetuximab had antitumor activity in second-line recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) Methods: this was a phase 2, open-label, randomized trial of EMD 1201081 0.32 mg/kg subcutaneously weekly plus cetuximab (combination) vs cetuximab monotherapy (control) in cetuximab-naïve patients with R/M SCCHN who progressed on 1 cytotoxic regimen. Crossover to combination was permitted after progression Results: objective response rate in both arms was 5.7 % (95 % CI 1.2-15.7 %) by independent assessment. Disease control was 37.7 % for patients on combination (24.8-52.1 %) and 43.4 % on control (29.8-57.7 %). Neither independent nor investigator assessments showed significant differences between study arms. Median progression-free survival was 1.5 months (1.3-2.6) for patients on combination, and 1.9 months (1.5-2.9) on control. The most frequent adverse events in the combination arm were rash (29.6 %), acneiform dermatitis (22.2 %), and injection site reactions (20.4 %). Grade 3/4 dyspnea and hypokalemia were more frequent with cetuximab monotherapy (7.5 % and 5.7 % vs 1.9 % each, respectively), and grade 3/4 respiratory failure and disease progression were more frequent with combination (5.6 % each vs 1.9 % each) Conclusion: EMD 1201081 was well tolerated combined with cetuximab, but there was no incremental clinical efficacy.

Original languageEnglish
Pages (from-to)1278-1284
Number of pages7
JournalInvestigational New Drugs
Issue number6
Publication statusPublished - Dec 1 2014



  • Cetuximab
  • Epidermal growth factor receptor-neu receptor
  • Head and neck cancer
  • Oligonucleotide
  • Randomized phase 2
  • Recurrent metastatic
  • Squamous cell carcinoma
  • Toll-like receptor 9

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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