Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis

SS Ramalingam; JE Gray; Y Ohe; BC Cho; J Vansteenkiste; C Zhou; T Reungwetwattana; Y Cheng; B Chewaskulyong; R Shah; KH Lee; P Cheema; M Tiseo; T John; MC Lin; F Imamura; R Hodge; Y Rukazenkov; J-C Soria; D Planchard

Conference Proceedings

Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis

SS Ramalingam, JE Gray, Y Ohe, BC Cho, J Vansteenkiste, C Zhou, T Reungwetwattana, Y Cheng, B Chewaskulyong, R Shah, KH Lee, P Cheema, M Tiseo, T John, MC Lin, F Imamura, R Hodge, Y Rukazenkov, J-C Soria, D Planchard

ANNALS OF ONCOLOGY | OXFORD UNIV PRESS | Published : 2019

DOI: 10.1093/annonc/mdz394.076

Abstract

Background Osimertinib is a 3rd-generation, irreversible, oral EGFR-TKI that potently and selectively inhibits both EGFR-mutated (EGFRm) and EGFR T790M resistance mutations, and has demonstrated efficacy in NSCLC CNS metastases. In the phase III FLAURA study (NCT02296125), osimertinib resulted in significant progression-free survival (PFS) benefit (primary endpoint; datacut off [DCO] 12 June 2017) over comparator EGFR-TKI (HR 0.46, p<0.001). Overall survival (OS) data were immature (25% maturity) at that time. Here, we report the final OS analysis (58% maturity). Methods Eligible patients (pts): ≥18 years (Japan: ≥20), treatment-naïve with Ex19del/L858R EGFRm advanced NSCLC; WHO performance ..

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