First-Line Osimertinib Effective Regardless of PD-L1 Expression in EGFR-Mutated NSCLC
An analysis of the phase 3 FLAURA trial demonstrated that osimertinib efficacy was not affected by PD-L1 tumor expression.
|The following article features coverage from the International Association for the Study of Lung Cancer (IASLC) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Osimertinib prolonged progression-free survival (PFS) compared with earlier-generation tyrosine kinase inhibitors (TKIs) — regardless of the level of PD-L1 tumor expression—among patients with advanced non-small cell lung cancer (NSCLC), according to an analysis of the phase 3 FLAURA trial presented at the IASLC's 19th World Conference on Lung Cancer in Toronto, Canada.1
Results from the trial demonstrated that osimertinib prolonged PFS compared with gefitinib or erlotinib in patients with EGFR-mutated NSCLC. The effect of PD-L1 expression, which is frequently expressed in tumors with EGFR mutations, on EGFR TKIs is unknown.
Of the 556 patients randomly assigned to treatment in the study, 106 (19%) harbored an EGFR mutation and had sufficient tissue for PD-L1 assessment. The SP296 (Ventana) immunohistochemistry test was used to evaluate PD-L1 tumor expression, and tumor cell (TC) staining of at least 1% was considered positive.
There was no significant difference in median PFS between among patients with positive versus negative PD-L1 tumor expression who received osimertinib. Treatment with osimertinib resulted in a median PFS of 18.4 compared with 6.9 months with gefitinib or erlotinib among patients whose tumors were PD-L1 positive (hazard ratio [HR], 0.30; 95% CI, 0.15-0.60). Similarly, the median PFS among patients whose tumors were negative for PD-L1 expression was 18.9 months with osimertinib compared with 10.9 months with gefitinib or erlotinib (HR, 0.37; 95% CI, 0.17-0.74).
The authors concluded that these data “support the efficacy of the EGFR-TKIs, including osimertinib, as first-line treatment of EGFR-mutated advanced NSCLC, irrespective of PD-L1 expression.”
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- Brown H, Vansteenkiste J, Nakagawa K, et al. PD-L1 expression in untreated EGFRm advanced NSCLC and response to osimertinib and SoC EGFR-TKIs in the FLAURA Trial. Presented at: International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer; Toronto, Canada; September 23-26, 2018. Abstract MA15.03.