1295P Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFR mutated (EGFRm) advanced NSCLC: FLAURA China study overall survival (OS)

In the phase III FLAURA study (NCT02296125), osimertinib significantly improved OS vs comparator EGFR-TKI (gefitinib/erlotinib) in treatment-naïve patients (pts) with EGFRm advanced NSCLC; OS hazard ratio (HR) 0.799, p=0.0462. In the FLAURA China study, osimertinib improved PFS vs comparator (HR 0.56, p=0.007); here we report OS in these pts. A cohort of Chinese pts were enrolled separately from the global study under the same protocol. Eligible pts: ≥18 years, treatment-naïve EGFRm advanced NSCLC; WHO performance status (PS) 0–1. Pts were randomised 1:1 to osimertinib 80 mg once daily (qd) orally (po) or comparator EGFR-TKI (all Chinese pts received gefitinib 250 mg qd po), and stratified by race (Asian/non-Asian) and mutation status (Ex19del/L858R). Note all pts in the FLAURA China cohort were in the stratum of Asian. Pts in the comparator EGFR-TKI arm could cross over upon confirmation of progression and T790M positivity. OS was a secondary endpoint. Data cut-off: 25 June 2019. 136 pts were randomised (osimertinib n=71; comparator EGFR-TKI n=65); 19 of these pts were included in the global analysis. Baseline characteristics were balanced across arms; WHO PS of 1: ≥80% in both arms. The median OS was 33.1 months for osimertinib compared with 25.7 months for the comparator arm (HR 0.848; Table). In the comparator arm, 22/65 pts (34%) crossed over to osimertinib. In the osimertinib and comparator arms, respectively, all causality adverse events (AEs) were reported in 99% and 98% of pts, grade ≥3 AEs: 54% and 28%, and AE leading to discontinuation: 13% and 6%. No new safety signals were identified.Table: 1295POsimertinib n=71Comparator EGFR-TKI n=65Median follow-up for OS*, mo31.024.9Deaths, n (%)45 (63)44 (68)Median OS, mo (95% CI)33.1 (26.0, 35.9)25.7 (19.6, 32.8)OS HR (95% CI) #0.848 (0.557, 1.291)Survival rate, % (95% CI)12 mo 24 mo 36 mo83 (72, 90) 64 (52, 74) 39 (27, 50)81 (70, 89) 54 (41, 66) 33 (21, 44)Median actual treatment duration, mo20.013.6Median TFST, mo (95% CI)21.4 (18.8, 27.4)15.8 (11.9, 20.0)TFST HR (95% CI)0.623 (0.424, 0.916)Median TSST, mo (95% CI)29.6 (23.1, 33.9)22.1 (17.4, 28.8)TSST HR (95% CI)0.785 (0.525, 1.175)*All pts.#This analysis was not powered for OS.CI, confidence interval; mo, months; TFST/TSST, time to first/second subsequent therapy or death. Open table in a new tab *All pts.#This analysis was not powered for OS.CI, confidence interval; mo, months; TFST/TSST, time to first/second subsequent therapy or death. In the FLAURA China study, median OS was extended by 7.4 months in the osimertinib arm vs comparator EGFR-TKI arm in the first-line treatment of pts with EGFRm advanced NSCLC, consistent with the global population where osimertinib extended OS by 6.8 months. Safety data were comparable with the global population.