Phase III success for nintedanib in NSCLC

New analysis of data from the LUME-Lung 1 Phase III clinical trial showed that the novel investigational compound nintedanib, from Boehringer Ingleheim, an oral triple angiokinase inhibitor that targets three receptors crucially involved in angiogenesis and tumour growth, provided a significant and clinically relevant overall survival benefit for advanced Non-Small Cell Lung Cancer (NSCLC) patients with adenocarcinoma histology. The results were presented at the European Cancer Congress in Amsterdam.

LUME-Lung 1 showed nintedanib plus docetaxel provided a statistically significant increase in median overall survival from 10.3 months in the placebo arm to 12.6 months in the nintedanib arm (HR: 0.83, p-value: 0.04). In addition, the data demonstrated that the earlier adenocarcinoma patients failed first line chemotherapy, the bigger the benefit that nintedanib provided. Compared to the overall adenocarcinoma patient population, patients with advanced adenocarcinoma who progressed within 9 months after start of their first-line treatment (T<9months) achieved a larger median overall survival benefit of 3 months (10.9 with nintedanib plus docetaxel vs. 7.9 months with placebo plus docetaxel.>

see-Mellemgaard A, Kaiser R, Douillard J-Y et al. Analysis of overall survival in adenocarcinoma NSCLC patients receiving 2nd line combination treatment with nintedanib (BIBF-1120) + docetaxel in the LUME-Lung 1 trial: a randomised, double-blind, placebo-controlled phase 3 study. Oral presentation on 29 September 2013 at 09.00 at The European Cancer Congress 2013 Abstract. no 3409.