JAVELIN Gastric 300: Phase 3 trial of avelumab (anti-PD-L1 antibody) + best supportive care (BSC) vs BSC ± chemotherapy as third-line treatment for...

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter Van Cutsem Eric
Citation Annals of Oncology (2016) 27 (2): 1-85. 10.1093/annonc/mdw199
Authors V.C. Eric1, W. Lucjan2, L. Keun-Wook3, C. Fortunato4, G. Rosine5, T. Julien6, G. Jayne7, B. Narikazu8, X. Huiling9, Z. Jenny10, C. Jean-Marie9, B. Yung-Jue10
  • 1University Hospital Gasthuisberg, Leuven, Belgium, /
  • 2M Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland, /
  • 3Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea, /
  • 4Second University of Naples, Naples, Italy, /
  • 5Toulouse III University, Department of Medical Oncology, Toulouse, France, /
  • 6Paris Descartes University, Sorbonne Paris-Cité Hopital Européen Georges Pompidou, Paris, France, /
  • 7Metairie Oncologists, Metairie, Louisiana, USA, /
  • 8Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, /
  • 9EMD Serono, Billerica, Massachusetts, USA, /
  • 10Seoul National University Hospital, Seoul, Republic of Korea, /

Abstract

In patients with gastric cancer that progressed following second-line chemotherapy, there is currently no standard of care. Single-agent chemotherapy is used, but has not demonstrated a survival advantage over best supportive care (BSC). Prognosis is poor and toxicity from chemotherapy may contribute to the limited benefit and cumulative risk for these late-line patients. Programmed death-1 receptor ligand (PD-L1) is a key therapeutic target in the reactivation of the immune response against multiple cancers. Avelumab* (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody that has shown promising efficacy and an acceptable safety profile in patients with various tumor types. In two phase 1 trials (JAVELIN Solid Tumor and JAVELIN Solid Tumor JPN), avelumab 10 mg/kg administered every 2 weeks (Q2W) showed antitumor activity in patients with advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC) as maintenance therapy in non-progressing patients after first-line chemotherapy and as second-line treatment. This randomized phase 3 trial, JAVELIN Gastric 300 (NCT02625623), compares avelumab + BSC vs BSC ± chemotherapy as third-line treatment for patients with GC/GEJC.