438P Efficacy of nintedanib/docetaxel in East Asian patients with lung adenocarcinoma (ADE): analysis from the LUME-Lung 1 study

Abstract

Aim/Background: In the Phase III LUME-Lung 1 study (LL1; NCT00805194; 1199.13), nintedanib (N; Vargatef®) + docetaxel (D) showed significant improvement in the key secondary endpoint overall survival (OS) in ADE patients compared to placebo (P) + D after 1st-line chemotherapy. Time since start of first-line therapy (TSFLT) was identified as a prognostic and predictive clinical marker for survival benefit with N + D in ADE patients (TSFLT <9 months: median OS 10.9 vs 7.9 months; HR 0.75 [95% CI 0.60-0.92], p = 0.0073). Here, we report findings from efficacy analyses in East Asian patients. Methods: Subgroup analyses in LL1 included the stratification baseline parameters ECOG PS, brain metastases and prior bevacizumab. Analyses of progression-free survival (PFS) and OS were conducted in East Asian patients with ADE (n = 123) (1) stratified by TSFLT 25th percentile (Q1; Q3) and (2) excluding patients with TSFLT >Q3 or