5Medical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, ... 13The James Cancer Hospital and Solove Research Institute, The Ohio State.
Annals of Oncology 25 (Supplement 4): iv394–iv405, 2014 doi:10.1093/annonc/mdu345.12
neuroendocrine & endocrine tumours and cup 1143P
PH II STUDY OF BEZ235 IN PATIENTS WITH ADVANCED PANCREATIC NEUROENDOCRINE TUMORS (PNET) AFTER MTOR INHIBITOR THERAPY FAILURE: STAGE I INTERIM RESULTS
abstracts
N. Fazio1, R. Buzzoni2, E. Baudin3, L. Antonuzzo4, R. Hubner5, H. Lahner6, W. W. De Herder7, M. Raderer8, A. Teule9, J. Capdevila10, S. Libutti11, M. Kulke12, M. Shah13, D. Dey14, S. Turri15, P. Aimone16, C. Verslype17 1 Unit of Gastrointestinal and Neuroendocrine Tumors, Istituto Europeo di Oncologia IEO, Milan, ITALY 2 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, ITALY 3 Oncologie, Institut Gustave Roussy, Villejuif, FRANCE 4 Medical Oncology, Azienda Ospedaliero Universitaria Careggi, Florence, ITALY 5 Medical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK 6 Clinic for Endocrinology, University of Duisburg-Essen, Essen, GERMANY 7 Endocrine Oncology, Erasmus MC, Rotterdam, NETHERLANDS 8 Department of Oncology, University Hospital of Vienna, Vienna, AUSTRIA 9 Medical Oncology, Institut Català d’Oncologia, Barcelona, SPAIN 10 Endocrine and Gastrointestinal Oncology, Vall d’Hebrón University Hospital, Barcelona, SPAIN 11 Department of Oncology - Surgery, Montefiore Medical Center and Albert Einstein College of Medicine, New York, NY, USA 12 Gastrointestinal Cancer, Dana–Farber Cancer Institute, Boston, MA, USA 13 The James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH, USA 14 Oncology, Novartis Healthcare Pvt Ltd, Hyderabad, INDIA 15 Oncology Global Development, Novartis AG, Basel, SWITZERLAND 16 Novartis Ag, Basel, SWITZERLAND 17 Department of Hepatology, KU Leuven, Leuven, BELGIUM Aim: The mTOR inhibitor everolimus is approved for the treatment of patients with advanced pNet but resistance can occur. BEZ235 (BEZ) is an oral, dual inhibitor that targets class I PI3K and downstream effectors mTORC1/2. Here we present interim
Stage I (open-label, single-arm) results of a multicenter, 2-stage, Ph II study of BEZ in patients with advanced pNET that had progressed on everolimus (NCT01658436). Methods: Patients with unresectable/metastatic histologically confirmed low/ intermediate-grade pNET with radiologic evidence of disease progression since last treatment and refractory to everolimus were enrolled. The starting dose of BEZ was 400 mg twice daily (BID), which was reduced to 300 mg BID due to the safety/ tolerability profile. The primary objective of Stage I was to evaluate the efficacy of BEZ based on the progression-free survival (PFS) rate at 16 weeks (RECIST v1.1). Futility was shown if the observed 16-week PFS rate was
