Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer
- Authors
- Soria, J. -C.; Ohe, Y.; Vansteenkiste, J.; Reungwetwattana, T.; Chewaskulyong, B.; Lee, K. H.; Dechaphunkul, A.; Imamura, F.; Nogami, N.; Kurata, T.; Okamoto, I.; Zhou, C.; Cho, B. C.; Cheng, Y.; Cho, E. K.; Voon, P. J.; Planchard, D.; Su, W. -C.; Gray, J. E.; Lee, S. -M.; Hodge, R.; Marotti, M.; Rukazenkov, Y.; Ramalingam, S. S.
- Issue Date
- 11-Jan-2018
- Publisher
- MASSACHUSETTS MEDICAL SOC
- Citation
- NEW ENGLAND JOURNAL OF MEDICINE, v.378, no.2, pp.113 - 125
- Journal Title
- NEW ENGLAND JOURNAL OF MEDICINE
- Volume
- 378
- Number
- 2
- Start Page
- 113
- End Page
- 125
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/4170
- DOI
- 10.1056/NEJMoa1713137
- ISSN
- 0028-4793
- Abstract
- BACKGROUND Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). METHODS In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1: 1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). The primary end point was investigator-assessed progression-free survival. RESULTS The median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P<0.001). The objective response rate was similar in the two groups: 80% with osimertinib and 76% with standard EGFR-TKIs (odds ratio, 1.27; 95% CI, 0.85 to 1.90; P = 0.24). The median duration of response was 17.2 months (95% CI, 13.8 to 22.0) with osimertinib versus 8.5 months (95% CI, 7.3 to 9.8) with standard EGFR-TKIs. Data on overall survival were immature at the interim analysis (25% maturity). The survival rate at 18 months was 83% (95% CI, 78 to 87) with osimertinib and 71% (95% CI, 65 to 76) with standard EGFR-TKIs (hazard ratio for death, 0.63; 95% CI, 0.45 to 0.88; P = 0.007 [nonsignificant in the interim analysis]). Adverse events of grade 3 or higher were less frequent with osimertinib than with standard EGFR-TKIs (34% vs. 45%). CONCLUSIONS Osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation-positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events.
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