Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib vs Comparator EGFR-TKI as First-Line Treatment in Patients with EGFR Mutated Advanced NSCLC.
Journal: 2019/August - Clinical Cancer Research
ISSN: 1078-0432
Abstract:

PURPOSE
To assess the utility of the cobas® EGFR Mutation Test, with tissue and plasma, for first-line osimertinib therapy for patients with EGFR-mutated (EGFRm) (Ex19del and/or L858R) advanced or metastatic non-small cell lung cancer (NSCLC) from the FLAURA study (NCT02296125).

EXPERIMENTAL DESIGN
Tumor tissue EGFRm status was determined at screening using the central cobas tissue test or a local tissue test. Baseline circulating tumor (ct)DNA EGFRm status was retrospectively determined with the central cobas plasma test.

RESULTS
f 994 patients screened, 556 were randomized (289 and 267 with central and local EGFR test results, respectively) and 438 failed screening. Of those randomized from local EGFR test results, 217 patients had available central test results; 211/217 (97%) were retrospectively confirmed EGFRm positive by central cobas tissue test. Using reference central cobas tissue test results, positive percent agreements with cobas plasma test results for Ex19del and L858R detection were: 79% (95% CI, 74-84) and 68% (95% CI, 61-75), respectively. Progression-free survival (PFS) superiority with osimertinib over comparator EGFR-TKI remained consistent irrespective of randomization route (central/local EGFRm positive tissue test). In both treatment arms, PFS was prolonged in plasma ctDNA EGFRm negative (23.5 and 15.0 months,) vs positive patients (15.2 and 9.7 months).

CONCLUSIONS
Our results support utility of cobas tissue and plasma testing to aid selection of patients with EGFRm advanced NSCLC for first-line osimertinib treatment. Lack of EGFRm detection in plasma was associated with prolonged PFS vs patients plasma EGFRm positive, potentially due to patients having lower tumor burden.

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