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Title: Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC
Authors: Suresh S. Ramalingam
Johan Vansteenkiste
David Planchard
Byoung Chul Cho
Jhanelle E. Gray
Yuichiro Ohe
Caicun Zhou
Thanyanan Reungwetwattana
Ying Cheng
Busyamas Chewaskulyong
Riyaz Shah
Manuel Cobo
Ki Hyeong Lee
Parneet Cheema
Marcello Tiseo
Thomas John
Meng Chih Lin
Fumio Imamura
Takayasu Kurata
Alexander Todd
Rachel Hodge
Matilde Saggese
Yuri Rukazenkov
Jean Charles Soria
Yonsei Cancer Center
Jilin Provincial Cancer Hospital
Shanghai Pulmonary Hospital
Chang Gung University College of Medicine
KU Leuven– University Hospital Leuven
Institut de Cancerologie Gustave Roussy
Kansai Medical University
Université Paris-Sud
National Cancer Center Hospital
University of Toronto
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Hospital Regional Universitario Carlos Haya
Università degli Studi di Parma, Facoltà di Medicina e Chirurgia
Chungbuk National University, College of Medicine
Austin Health
Moffitt Cancer Center
Maidstone Hospital
Emory University School of Medicine
Chiang Mai University
Osaka International Cancer Institute
Keywords: Medicine
Issue Date: 2-Jan-2020
Citation: New England Journal of Medicine. Vol.382, No.1 (2020), 41-50
Abstract: Copyright © 2019 Massachusetts Medical Society. BACKGROUND Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. A phase 3 trial compared firstline osimertinib with other EGFR-TKIs in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). The trial showed longer progressionfree survival with osimertinib than with the comparator EGFR-TKIs (hazard ratio for disease progression or death, 0.46). Data from the final analysis of overall survival have not been reported. METHODS In this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group). Overall survival was a secondary end point. RESULTS The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046). At 3 years, 79 of 279 patients (28%) in the osimertinib group and 26 of 277 (9%) in the comparator group were continuing to receive a trial regimen; the median exposure was 20.7 months and 11.5 months, respectively. Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group. CONCLUSIONS Among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group. (Funded by AstraZeneca; FLAURA number, NCT02296125.)
ISSN: 15334406
Appears in Collections:Scopus 2020

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