title: 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).
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  EMD 1201081 was well tolerated combined with cetuximab, but there was no incremental clinical efficacy.
authors.affiliation: Zala Megyei Kórház Külsokórház Onkológia Osztály, Zalaegerszeg, Pozva, Hungary.
authors.forename: A
authors.initials: A
authors.lastname: Ruzsa
authors.forename: M
authors.initials: M
authors.lastname: Sen
authors.forename: M
authors.initials: M
authors.lastname: Evans
authors.forename: L W
authors.initials: LW
authors.lastname: Lee
authors.forename: K
authors.initials: K
authors.lastname: Hideghety
authors.forename: S
authors.initials: S
authors.lastname: Rottey
authors.forename: P
authors.initials: P
authors.lastname: Klimak
authors.forename: P
authors.initials: P
authors.lastname: Holeckova
authors.forename: J
authors.initials: J
authors.lastname: Fayette
authors.forename: T
authors.initials: T
authors.lastname: Csoszi
authors.forename: J
authors.initials: J
authors.lastname: Erfan
authors.forename: U
authors.initials: U
authors.lastname: Forssmann
authors.forename: T
authors.initials: T
authors.lastname: Goddemeier
authors.forename: A
authors.initials: A
authors.lastname: Bexon
authors.forename: C
authors.initials: C
authors.lastname: Nutting
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D000068818:Cetuximab; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009841:Oligonucleotides / Q000008:administration & dosage / Q000009:adverse effects; D066066:Response Evaluation Criteria in Solid Tumors; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C587694:IMO-2055; D009841:Oligonucleotides; D000068818:Cetuximab