Meeting
2018 ASCO-SITC Clinical Immuno-Oncology Symposium
Efficacy and safety of CetuGEX in recurrent/metastatic squamous cell carcinoma of the head and neck (RM-HNSCC): Results from the randomized phase II RESGEX study.
Authors
Ulrich Keilholz
Charité Comprehensive Cancer Center, Berlin, Germany
Ulrich Keilholz, Andrzej Kawecki, Andreas Dietz, Bogdan Zurawski, Michael Schenker, Bozena Kukielka-Budny, Philippe Schafhausen, Anca C. Mihailov, Sebastian Ochenduszko, Ilaria Imarisio, Simona Mihutiu, Cristina-Marinela Oprean, Gunnar Folprecht, Alina Turcu, Sylvie Rottey, Philippe Debourdeau, Javier Lavernia, Bruno Dietrich, Alfredo Zurlo, Jerome Fayette
Organizations
Charité Comprehensive Cancer Center, Berlin, Germany, Cancer Center-M.Sklodowska-Curie Memorial Institute, Warsaw, Poland, University of Leipzig, Leipzig, Germany, Outpatient Chemotherapy, the F. Lukaszczyk Oncology Center, Bydgoszcz, Poland, Bydgoszcz, Poland, S.C Centrul de Oncologie, Policlinica Sf. Nectarie, Craiova, Romania, Oncology Center, Lublin, Poland, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany, University Hospital Cluj, Cluj Napoca, Romania, Krakow University Hospital Oncology Clinic, Krakow, Poland, Medical Oncology Department, IRCCS San Matteo University Hospital Foundation, Pavia, Italy, Emergency Clinical Hospital Oradea, Oradea, Bihor, Romania, ONCOMED SRL, Timisoara, Romania, University Hospital Carl Gustav Carus, Dresden, Germany, SPITAL LOTUS SRL, Ploiesti, Romania, Ghent University Hospital, Heymans Institute of Pharmacology, Ghent, Belgium, Institut Sainte-Catherine, Avignon, France, F.I.V.O., Valencia, Spain, Glycotope GmbH, Berlin, Germany, Medical Oncology, Centre Léon Bérard, Lyon, France
Research Funding
Pharmaceutical/Biotech Company
Background: Standard treatment for RM-HNSCC is a combination of cisplatin (P), 5-FU (F), and the epidermal growth factor receptor (EGFR) blocking monoclonal antibody cetuximab. CetuGEX is a new monoclonal antibody sharing the identical EGFR-binding domain with cetuximab, but a modified Fc part by a proprietary glycosylation method to optimize antibody dependent cellular cytotoxicity (ADCC). Methods: Patients with RM-HNSCC without relevant comorbidities were randomized to receive up to 6 cycles of P 100 mg/m2, F 4 x 1000 mg/m2/24hrs and CetuGEX vs. cetuximab. Initial dose of cetuximab was 400mg/m2, followed by weekly 250 mg/m2. CetuGEX was given as 990 mg, followed by weekly 720 mg. After end of combination treatment, patients received single agent antibody maintenance until disease progression or intolerable toxicity. Stratification factors included FcγRIIIa status, primary tumor site, EGFR pretreatment vs. naïve, and recurrent vs. metastatic disease. Primary endpoint was progression-free survival (PFS) by immune related response criteria (irRC). Secondary endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS) as well as safety and QoL. Results: During Jan 2014 and Feb 2016, 240 patients were accrued in 34 European centers, of which 123 received cetuximab and 117 CetuGEX. The median follow-up was 15 month until May 2017. No difference was observed for the primary endpoint of PFS by irRC [median 27.7 (CetuGEX) and 26.4 (cetuximab) weeks; HR 1.003; 95%-CI 0.738 – 1.363; p = 0.98]. No advantage of CetuGEX over cetuximab was observed for all other secondary efficacy endpoints and subgroup analyses by stratification factors. Infusion related reactions (IRR) were higher for CetuGEX (38.8%) than for cetuximab (5.7%) (Pearson chi2= 37.08; p < 0.0001), but without sequelae. Conclusions: The RESGEX study is the first head-to-head comparison of an ADCC-optimized to a conventional EGFR-directed antibody. The study failed to show superior efficacy of CetuGEX over cetuximab. Both compounds appear to have the same efficacy and a similar safety profile. Glycosylation changes in the Fc part induced more IRRs. Clinical trial information: NCT02052960
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session A
Track
Developmental Therapeutics,Genitourinary Cancer,Head and Neck Cancer,Lung Cancer,Melanoma/Skin Cancers,Gastrointestinal Cancer,Breast and Gynecologic Cancers,Combination Studies,Implications for Patients and Society,Miscellaneous Cancers,Oncolytic Viruses,Hematologic Malignancies
Sub Track
Immune Checkpoints and Stimulatory Receptors
Clinical Trial Registration Number
NCT02052960
Citation
J Clin Oncol 36, 2018 (suppl 5S; abstr 59)
DOI
10.1200/JCO.2018.36.5_suppl.59
Abstract #
59
Poster Bd #
D5
Abstract Disclosures
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