Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset. (1st December 2018)

• Record Type: Journal Article
• Authors: Ohe, Yuichiro; Imamura, Fumio; Nogami, Naoyuki; Okamoto, Isamu; Kurata, Takayasu; Kato, Terufumi; Sugawara, Shunichi; Ramalingam, Suresh S; Uchida, Hirohiko; Hodge, Rachel; Vowler, Sarah L; Walding, Andrew; Nakagawa, Kazuhiko
• Is Part Of: Japanese journal of clinical oncology. Volume 49:Number 1(2019)
• Page Start: 29
• Page End: 36
• Publication Date: 2018-12-01
• Subjects: clinical trials -- lung medicine -- thoracic; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyy179
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract : In the FLAURA trial Japanese subset, osimertinib significantly improved median PFS versus standard-of-care (gefitinib) in patients with previously untreated EGFR (exon 19 deletion or L858R) mutation-positive advanced or metastatic NSCLC. Abstract: Background: The FLAURA study was a multicenter, double-blind, Phase 3 study in which patients with previously untreated epidermal growth factor receptor mutation-positive advanced non-small-cell lung carcinoma were randomized 1:1 to oral osimertinib 80 mg once daily or standard-of-care (gefitinib 250 mg or erlotinib 150 mg, once daily) to compare safety and efficacy. In the overall FLAURA study, significantly better progression-free survival was shown with osimertinib versus standard-of-care. Methods: Selected endpoints, including progression-free survival (primary endpoint), overall survival, objective response rate, duration of response and safety were evaluated for the Japanese subset of the FLAURA study. Results: In Japan, 120 eligible Japanese patients were randomized to osimertinib (65 patients) or gefitinib (55 patients) treatment from December 2014 to June 2017. Median progression-free survival was 19.1 (95% confidence interval, 12.6, 23.5) and 13.8 (95% confidence interval, 8.3, 16.6) months with osimertinib and gefitinib, respectively (hazard ratio, 0.61; 95% confidence interval, 0.38, 0.99). Median overall survival was not reached in either treatment arm (data were immature). In the osimertinib and gefitinib arms, objective response rate was 75.4% (49/65) and 76.4% (42/55), and median duration of response from onset was 18.4 (95% confidence interval, not calculated) and 9.5 (95% confidence interval, 6.2, 13.9) months, respectively. The incidence of adverse events was similar in the two groups. The frequency of Grade ≥3 interstitial lung disease and pneumonitis in the two groups were the same (one patient). Conclusions: As the first-line therapy, osimertinib showed significantly improved efficacy versus gefitinib in the Japanese population of the FLAURA study. No new safety concerns were raised. Clinical trial registration: NCT02296125 (ClinicalTrials.gov)