A pivotal phase 3 trial of MABp1 in advanced colorectal cancer

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter T. Hickish
Citation Annals of Oncology (2016) 27 (2): 118-128. 10.1093/annonc/mdw198
Authors T. Hickish1, T. André2, L. Wyrwicz3, M. Saunders4, T. Sarosiek5, R. Nemecek6, J. Kocsis7, M. Stecher8, A. de Gramont9
  • 1Oncology Department, Royal Bournemouth Hospital NHS Foundation Trust, Bournemouth, United Kingdom, /
  • 2Saint Antoine Hospital, Paris, France, /
  • 3M Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland, /
  • 4Christie Hospital NHS Foundation Trust, Manchester, United Kingdom, /
  • 5Magodent, Warsaw, Poland, /
  • 6Masaryk Memorial Cancer Institute, Brno, Czech Republic, /
  • 7University of Debrecen, Debrecen, Hungary, /
  • 8XBiotech USA, Inc., Austin, Texas, USA, /
  • 9Oncology Department, Institut Hospitalier Franco-Britannique, Levallois-Perret, France, /

Abstract

The incidence of colorectal cancer (CRC) is associated with economic development and is the second leading cause of cancer in the industrialized world. At least half of patients diagnosed will progress and succumb to the disease. Consequently, a substantial and growing unmet need exists for a therapy to treat patients with advanced CRC. We evaluated a novel anti-IL-1 alpha antibody therapy in patients with advanced disease and multiple symptoms known to inversely correlate with overall survival. OR criteria were developed in collaboration with EMA's Scientific Advice Working Group to assess anti-tumor benefit of therapy based on control of these symptoms.