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Title: Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC.
Austin Authors: Ramalingam, Suresh S;Vansteenkiste, Johan;Planchard, David;Cho, Byoung Chul;Gray, Jhanelle E;Ohe, Yuichiro;Zhou, Caicun;Reungwetwattana, Thanyanan;Cheng, Ying;Chewaskulyong, Busyamas;Shah, Riyaz;Cobo, Manuel;Lee, Ki Hyeong;Cheema, Parneet;Tiseo, Marcello;John, Thomas ;Lin, Meng-Chih;Imamura, Fumio;Kurata, Takayasu;Todd, Alexander;Hodge, Rachel;Saggese, Matilde;Rukazenkov, Yuri;Soria, Jean-Charles
Affiliation: the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France
Pulmonary Hospital of Tongji University, Shanghai, China
Early Oncology Research and Development, AstraZeneca, Gaithersburg, MD
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan
Kent Oncology Centre, Maidstone Hospital, and Tunbridge Wells NHS Trust, Maidstone, United Kingdom
Late Oncology Statistics and Oncology Research and Development , AstraZeneca, Cambridge, United Kingdom
Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia
Jilin Provincial Cancer Hospital, Changchun,China
Winship Cancer Institute, Emory University School of Medicine, Atlanta
University Paris Sud, Orsay, France
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea
Division of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea
Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan
Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan
Hospital Regional Universitario Málaga, Instituto de Investigación Biomédica de Málaga, Malaga, Spain
William Osler Health System, University of Toronto, Toronto
Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, University Hospital of Parma, Parma, Italy
Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai, Thailand
Issue Date: 2020 2019-11-21
Publication information: The New England Journal of Medicine 2020; 382(1): 41-50
Abstract: 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 first-line osimertinib with other EGFR-TKIs in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). The trial showed longer progression-free 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. 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. 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. 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.).
DOI: 10.1056/NEJMoa1913662
PubMed URL: 31751012
Type: Journal Article
Appears in Collections:Journal articles

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