Phase III study of Vargatef (Boehringer) meets primary endpoint in patients with NSCLC

Results from the Phase III LUME-Lung 1 study show that the addition of Vargatef (nintedanib), from Boehringer, to docetaxel improved progression-free survival (PFS) - the primary endpoint - as a second-line treatment in patients with advanced Non-Small Cell Lung Cancer (NSCLC) compared to docetaxel alone. Secondary endpoints included overall survival (OS). The trial enrolled 1,314 patients with advanced NSCLC whose disease progressed after first-line chemotherapy.

Results showed patients treated with nintedanib plus docetaxel lived for a median of 3.4 months before their tumor started to grow again, versus 2.7 months with docetaxel alone. In the full study population, the median OS was 10.1 months in the nintedanib combination arm versus 9.1 months with docetaxel alone. In patients with adenocarcinoma histology, the median OS was 12.6 months in the nintedanib combination arm versus 10.3 months with docetaxel alone.

The most common adverse events (AEs) of any grade in the nintedanib combination and docetaxel alone groups were diarrhea (42.3 vs. 21.8 percent, respectively) and ALT elevations (28.5 vs. 8.4 percent, respectively). Data was presented at ASCO.