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1、Presented by VA Papadimitrakopoulou at the World Conference on Lung Cancer 2016 Plenary Session: PL03 Presidential Symposium (abstract PL03.03),Vassiliki A Papadimitrakopoulou1, Yi-Long Wu2, Myung-Ju Ahn3, Suresh S Ramalingam4, Marina Chiara Garassino5, Hye Ryun Kim6, Frances A Shepherd7, Hiroaki Ak
2、amatsu8, Willemijn SME Theelen9, Chee Khoon Lee10, Martin Sebastian11, Alison Templeton12, Marcelo Marotti12, Serban Ghiorghiu12, Tony Mok13,Randomised Phase III study of osimertinib vs platinum-pemetrexed for EGFR T790M-positive advanced NSCLC (AURA3),1Department of Thoracic/Head and Neck Medical O
3、ncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Guangdong Lung Cancer Institute, Guangdong General Hospital 13Key Laboratory of South China, Department of Clinical Oncology, The Chinese University of Hong Kong, Sha Tin, Hong Kong,Disclosures,Vassiliki A Papadimitrakopo
4、ulou: 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
5、/ 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: h
6、onoraria 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 Marot
7、ti, 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
8、 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 honorari
9、a 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 Gar
10、assino: consultancy for AstraZeneca, Roche, Eli Lilly Myung-Ju Ahn, Hye Ryun Kim, Willemijn SME Theelen: none declared,Introduction,Osimertinib is an oral, irreversible, CNS-active, EGFR-TKI selective for both sensitising (EGFRm) and EGFR T790M resistance mutations1,2 Previous global Phase II studie
11、s 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 AURA extension (N=201): ORR (by BICR) was 62%, median PFS 12.3 months and median DoR 15.2 months AURA2 (N=21
12、0): 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 centrally-confirmed EGFR T790M-positive advanced NSCLC whos
13、e disease had progressed on first-line EGFR-TKI therapy,1. Cross et al. Cancer Discov 2014;4:104661; 2. Ballard et al. Clin Cancer Res 2016;22:513040; 3. Yang et al. AURA extension manuscript in preparation; 4. Goss et al. Lancet Oncol 2016 ePub ahead of print AURA extension: NCT01802632; AURA2: NCT
14、02094261; 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
15、 inhibitor,AURA3 study design,Key eligibility criteria 18 years (20 years in Japan) Locally advanced or metastatic NSCLC Evidence of disease progression following first-line EGFR-TKI therapy Documented EGFRm and central confirmation of tumour EGFR T790M mutation from a tissue biopsy taken after dise
16、ase progression on first-line EGFR-TKI treatment WHO performance status of 0 or 1 No more than one prior line of treatment for advanced NSCLC No prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior to starting first EGFR-TKI treatment Stable* asymptomatic CNS metastases allowed,R 2:1,Osimertinib (n=279) 80 mg orally QD,Platinum-pemetrexed (n=140) Pemetrexed 500 mg/m2 + carboplatin AUC5 or cisplatin 75 mg/m2 Q3W for up to 6 cycles + optional maintenance pemetrexed#,O
