Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC

FLAURA Japanese subset

Yuichiro Ohe, Fumio Imamura, Naoyuki Nogami, Isamu Okamoto, Takayasu Kurata, Terufumi Kato, Shunichi Sugawara, Suresh S. Ramalingam, Hirohiko Uchida, Rachel Hodge, Sarah L. Vowler, Andrew Walding, Kazuhiko Nakagawa

Research output: Contribution to journalArticle

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).

Original languageEnglish
Pages (from-to)29-36
Number of pages8
JournalJapanese journal of clinical oncology
Volume49
Issue number1
DOIs
Publication statusPublished - Jan 1 2019

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Standard of Care
Confidence Intervals
Disease-Free Survival
Safety
Therapeutics
Survival
Interstitial Lung Diseases
Epidermal Growth Factor Receptor
Non-Small Cell Lung Carcinoma
osimertinib
Pneumonia
Japan
gefitinib
Clinical Trials
Mutation
Incidence
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC : FLAURA Japanese subset. / 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.

In: Japanese journal of clinical oncology, Vol. 49, No. 1, 01.01.2019, p. 29-36.

Research output: Contribution to journalArticle

Ohe, Y, Imamura, F, Nogami, N, Okamoto, I, Kurata, T, Kato, T, Sugawara, S, Ramalingam, SS, Uchida, H, Hodge, R, Vowler, SL, Walding, A & Nakagawa, K 2019, 'Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset', Japanese journal of clinical oncology, vol. 49, no. 1, pp. 29-36. https://doi.org/10.1093/jjco/hyy179
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. / Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC : FLAURA Japanese subset. In: Japanese journal of clinical oncology. 2019 ; Vol. 49, No. 1. pp. 29-36.
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AU - Ohe, Yuichiro

AU - Imamura, Fumio

AU - Nogami, Naoyuki

AU - Okamoto, Isamu

AU - Kurata, Takayasu

AU - Kato, Terufumi

AU - Sugawara, Shunichi

AU - Ramalingam, Suresh S.

AU - Uchida, Hirohiko

AU - Hodge, Rachel

AU - Vowler, Sarah L.

AU - Walding, Andrew

AU - Nakagawa, Kazuhiko

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N2 - 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).

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