A randomized phase II study comparing the efficacy and safety of the glyco-optimized anti-EGFR antibody tomuzotuximab against cetuximab in patients with recurrent and/or metastatic squamous cell cancer of the head and neck - the RESGEX study

Research output: Contribution to journalResearch articleContributedpeer-review


  • K Klinghammer - , Charité – Universitätsmedizin Berlin (Author)
  • J Fayette - , Leon Bérard Cancer Center (Author)
  • A Kawecki - , Cancer Center-Maria Sklodowska-Curie Memorial Institute (Author)
  • A Dietz - , University Hospital Leipzig (Author)
  • P Schafhausen - , University Hospital Hamburg Eppendorf (Author)
  • G Folprecht - , Department of internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • S Rottey - , Ghent University Hospital (Author)
  • P Debourdeau - , Institut Sainte Catherine (Author)
  • J Lavernia - , F.I.V.O (Author)
  • A Jacobs - , Premier Research (Author)
  • I Ahrens-Fath - , Glycotope GmbH (Author)
  • B Dietrich - , Glycotope GmbH (Author)
  • H Baumeister - , Glycotope GmbH (Author)
  • A Zurlo - , Glycotope GmbH (Author)
  • S Ochsenreither - , Charité – Universitätsmedizin Berlin (Author)
  • U Keilholz - , Charité – Universitätsmedizin Berlin (Author)


BACKGROUND: The aim of the RESGEX study was to compare the efficacy and safety of the anti-epidermal growth factor receptor (anti-EGFR) antibody tomuzotuximab against cetuximab both in combination with chemotherapy in patients with recurrent and/or metastatic squamous cell cancer of the head and neck in the first-line treatment.

PATIENTS AND METHODS: In this phase II trial 240 patients were equally randomized for six cycles to receive either tomuzotuximab (initial dose 990 mg then 720 mg) weekly and cisplatin 100 mg/m2 and fluorouracil (5-FU; 1000 mg/m2/day, days 1-4) every 3 weeks or cetuximab (400 mg/m2 subsequent 250 mg/m2) weekly with the same chemotherapeutic backbone followed by antibody maintenance treatment. The primary endpoint was progression-free survival.

RESULTS: Median progression-free survival was 6.5 months [95% confidence interval (CI) 5.9-7.9 months] in the tomuzotuximab group and 6.2 months (95% CI 5.8-7.3 months) in the cetuximab group (P = 0.86). The median overall survival (OS) estimate was 11.6 months (95% CI 9.5-17.2 months) in the tomuzotuximab group and 13.8 months (95% CI 12.3-16.4 months) in the cetuximab group (P = 0.96). In an exploratory analysis a small subgroup of p16-positive patients had a significantly longer OS compared with p16-negative patients (hazard ratio 1.860, 95% CI 1.09-3.16, P = 0.02).

CONCLUSIONS: The glyco-engineered antibody tomuzotuximab failed to demonstrate improved efficacy with a chemotherapeutic backbone in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. It remains a so far unanswered question whether such antibody would partner better with different drugs such as checkpoint inhibitors.


Original languageEnglish
Pages (from-to)100242
JournalESMO open
Issue number5
Publication statusPublished - Oct 2021

External IDs

PubMedCentral PMC8424211
Scopus 85120319599
ORCID /0000-0002-9321-9911/work/142251956


Sustainable Development Goals


  • Antineoplastic Combined Chemotherapy Protocols/adverse effects, Carcinoma, Squamous Cell/drug therapy, Cetuximab/therapeutic use, Epithelial Cells, Head and Neck Neoplasms/drug therapy, Humans, Neoplasm Recurrence, Local/drug therapy