JAVELIN Gastric 100: Phase 3 trial of avelumab (anti-PD-L1 antibody) maintenance therapy vs continuation of first-line chemotherapy in patients wit...

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter Taieb Julien
Citation Annals of Oncology (2016) 27 (2): 1-85. 10.1093/annonc/mdw199
Authors T. Julien1, D.B. Maria2, C. Antonio3, G. Jayne4, W. Deborah5, X. Huiling6, Z. Jenny6, C. Jean-Marie6, B. Narikazu7, M. Markus8
  • 1Paris Descartes University, Sorbonne Paris-Cité Hopital Européen Georges Pompidou, Paris, France, /
  • 2Istituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy, /
  • 3Hospital Universitario HM Madrid Sanchinarro, Madrid, Spain, /
  • 4Metairie Oncologists, Metairie, Louisiana, USA, /
  • 5Mercy Cedar Rapids, Cedar Rapids, Iowa, USA, /
  • 6EMD Serono, Billerica, Massachusetts, USA, /
  • 7Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, /
  • 8Johannes-Gutenberg University Mainz, Mainz, Germany, /

Abstract

Patients with metastatic gastric cancer have a poor prognosis, despite the use of multi-drug chemotherapy regimens. While in some patients these may provide initial clinical benefit, continued use results in cumulative toxicity. Thus, treatment options that improve upon the initial benefit from chemotherapy while reducing the potential for cumulative toxicity are needed in the first-line (1L) treatment setting. 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 the phase 1 JAVELIN Solid Tumor and JAVELIN Solid Tumor JPN trials, 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. A phase 3 trial, JAVELIN Gastric 100 (NCT02625610), has been initiated to compare efficacy and safety of single-agent avelumab as switch maintenance treatment vs continuation of 1L chemotherapy in patients with GC/GEJC.