1. Cross et al. Cancer Discov 2014;4:1046–61; 2. Ballard et al. Clin Cancer Res 2016;22:5130–40; 3. Yang et al. AURA extension manuscript in preparation; 4. Goss et al. Lancet Oncol 2016 [ePub ahead of print] AURA extension: NCT01802632; AURA2: NCT02094261; AURA3: NCT02151981 BICR, Blinded Independent Central Review; CNS, central nervous system; DoR, duration of response; EGFR, epidermal growth factor receptor; ORR, objective response rate; NSCLC, non-small cell lung cancer; PFS, progression-free survival; QD, once daily; TKI, tyrosine kinase inhibitor
of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China; 3Samsung Medical Center, Seoul, Republic of Korea; 4Emory University, Winship Cancer Institute, Atlanta, GA, USA; 5Medical Oncology Department, Thoracic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 6Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine, Seoul, Republic of Korea; 7Princess Margaret Cancer Centre, Toronto, Canada; 8Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan; 9Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands; 10St George Hospital, Clinical Research Unit, Division of Cancer Services, Pitney Clinical Sciences Building, Kogarah, New South Wales, Australia; 11University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany; 12AstraZeneca, Cambridge, UK; 13Key Laboratory of South China, Department of Clinical Oncology, The Chinese University of Hong Kong, Sha Tin, Hong Kong
• Previous global Phase II studies showed osimertinib 80 mg QD provides clinically meaningful efficacy with minimal side effects in patients with EGFR T790M-positive NSCLC, whose disease had progressed on EGFR-TKI therapy3,4
• • • • • • • •
பைடு நூலகம்
• •
Introduction
• Osimertinib is an oral, irreversible, CNS-active, EGFR-TKI selective for both sensitising (EGFRm) and EGFR T790M resistance mutations1,2
AURA extension (N=201): ORR (by BICR) was 62%, median PFS 12.3 months and median DoR 15.2 months AURA2 (N=210): ORR (by BICR) was 70%, median PFS 9.9 months and median DoR 11.4 months AURA3 is the first randomised Phase III study to compare an EGFR T790M-selective EGFR-TKI (osimertinib) against platinum-based doublet chemotherapy in patients with centrallyconfirmed EGFR T790M-positive advanced NSCLC whose disease had progressed on first-line EGFR-TKI therapy
Disclosures
• Vassiliki A Papadimitrakopoulou: consultancy for AstraZeneca, ARIAD, BMS, Genentech, Biothera, Janssen, Clovis, Merck, Eli Lilly; grants / research support from AstraZeneca, Genentech, Merck, BMS, Novartis, Janssen, ACEA Biosciences, Celgene, Clovis; honoraria from prIME Oncology, Imedex, CancerNet, CEC Yi-Long Wu: honoraria / speaker fees from AstraZeneca, Roche, Eli Lilly, Pfizer, Sanofi Suresh S Ramalingam: consultancy for Amgen, Abbvie, AstraZeneca, BMS, BI, Celgene, Merck, Lilly, Genentech Frances A Shepherd: consultancy for AstraZeneca, Roche; stock shareholder in and honoraria from AstraZeneca Hiroaki Akamatsu: honoraria from AstraZeneca, Eli Lilly, Chugai pharmaceuticals, BI, Merck, Pfizer, Ono pharmaceutical, Taiho pharmaceutical, Novartis Chee Khoon Lee: honoraria from AstraZeneca Martin Sebastian: consultancy for and honoraria from Roche, BI, AstraZeneca, Novartis, Pfizer Alison Templeton, Marcelo Marotti, Serban Ghiorghiu: employed by and stock shareholder in AstraZeneca Tony Mok: employed by The Chinese University of Hong Kong; speakers bureau for AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, MSD, Amgen, Janssen, Clovis Oncology, GSK, Novartis, BMS, PrIME Oncology; grants/research support from AstraZeneca, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS; consultancy for AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, Merck Serono, MSD, Janssen, Clovis Oncology, BioMarin, GSK, Novartis, SFJ Pharmaceutical, ACEA Biosciences, Inc., Vertex Pharmaceuticals, Aveo & Biodesix, BMS, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene; stock shareholder in Sanomics Ltd.; honoraria for AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, Merck Serono, MSD, Janssen, Clovis Oncology, BioMarin, GSK, Novartis, SFJ Pharmaceutical, ACEA Biosciences, Inc., Vertex Pharmaceuticals, BMS, AVEO & Biodesix, Prime Oncology, Amgen, OncoGenex Pharmaceuticals, Inc., Celgene Marina Chiara Garassino: consultancy for AstraZeneca, Roche, Eli Lilly Myung-Ju Ahn, Hye Ryun Kim, Willemijn SME Theelen: none declared