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  • Osimertinib versus standard...
    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

    Japanese journal of clinical oncology, 01/2019, Volume: 49, Issue: 1
    Journal Article

    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)