473P - Prior Taxane Use in the Lume-Lung 1 Phase III Trial and the Effect on Outcome Following 2Nd-Line Treatment with Nintedanib (Bibf 1120) and Docetaxel in Patients with Advanced Nsclc

Abstract

ABSTRACT Aim: Several Phase III studies confirm the efficacy of standard 2nd-line docetaxel (D) in advanced non-small cell lung cancer (NSCLC) patients (pts) previously treated with 1st-line paclitaxel-based therapy irrespective of tumour histology. In LUME-Lung 1, nintedanib (N)—an oral, triple angiokinase inhibitor of VEGF, PDGF and FGF signalling—has demonstrated clinically meaningful efficacy along with 2nd-line chemotherapy (NCT00805194; 1199.13). Here we report the efficacy and safety of N + D in pts previously treated with taxanes as part of a preplanned analysis. Methods: Stage IIIB/IV recurrent NSCLC pts (N = 1314) progressing after 1st-line chemotherapy were randomised 1:1 to receive either N 200 mg bid + D 75 mg/m2 q21d (n = 655) or placebo (Pl) + D (n = 659). Endpoints evaluated included progression-free survival (PFS) by central independent review, overall survival (OS) and safety. Chemotherapy with 1st-line D was an exclusion criterion; subgroup analyses according to the pt's use of 1st-line taxane therapy and NSCLC histology were also performed. Results: Pt characteristics were balanced across all groups. For all pts and those with adenocarcinoma (Ad) in particular, no significant difference in survival benefit was noted regardless of the use of 1st-line taxane therapy (Table). Comparison of N + D and Pl + D showed that the percentage of all pts with grade ≥3 adverse events (AEs) was slightly higher for pts in the N arm (no 1st-line taxane = 71.6% vs 65.5%; prior 1st-line taxane = 70.3% vs 59.4%). Consistent with overall findings in LUME-Lung 1, reversible increases in alanine and aspartate aminotransferases as well as diarrhoea were the AEs that were more common among all pts in the N arm. OS results for LUME-Lung 1 in NSCLC pts who received 1st-line taxane therapy All pts Pts with Ad No taxane 1st-line Taxane 1st-line No taxane 1st-line Taxane 1st-line N, n = 510 Pl, n = 519 N, n = 145 Pl, n = 140 N, n = 245 Pl, n = 271 N, n = 77 Pl, n = 65 Median OS, months 10.0 9.1 11.5 9.0 12.2 10.3 15.1 11.6 HR (95% CI); p-value 0.97 (0.85–1.11); p = 0.67 0.81 (0.62–1.06); p = 0.13 0.86 (0.71–1.05); p = 0.13 0.75 (0.51–1.11); p = 0.15 Interaction between treatment & subgroup variable, p-value p = 0.2562 p = 0.6135 Conclusions: On-study treatment with N + D resulted in a comparably favourable OS improvement regardless of whether pts with tumours of Ad histology were treated 1st line with a taxane- or non-taxane-containing platinum doublet. Disclosure: A. Mellemgaard: Advisory Board: Boehringer Ingelheim; J. von Pawel: Advisory Board/Consultant: AbbVie, Clovis, Daiichi Sankyo, Novartis, Pfizer, Vertex Pharmaceuticals; J. Barrueco: Employee: Boehringer Ingelheim Pharmaceuticals Inc., USA; B. Gaschler-Markefski and R. Kaiser: Employee: Boehringer Ingelheim Pharma GmbH KG, Germany S. Novello: Advisory Board/Honoraria/Invited Speaker: AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Roche; J. Douillard: Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Merck Serono, Roche; Educational Symposia: Amgen, AstraZeneca, Bayer; Research Grants: Merck Serono; M. Reck: Advisory Board: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Hoffmann-la Roche, Lilly, Novartis, Pfizer. All other authors have declared no conflicts of interest.