IDMC halts Phase III study of Vargatef (Boehringer) in NSCLC

The LUME-LUNG 2 double-blinded Phase III study evaluating Vargatef (nintedanib), from Boehringer, plus pemetrexed compared to pemetrexed plus placebo in patients with advanced non-squamous NSCLC has been halted at the recommendation of the Independent Data Monitoring Committee after 713 patients had been enrolled. This decision was based on the results of an interim review of efficacy (PFS) for a pre-defined futility analysis, and was not safety related.

Patients treated with nintedanib plus pemetrexed (n=353) lived for a median of 4.4 months before their tumor started to grow again (PFS), compared to 3.6 months for patients assigned to the pemetrexed plus placebo arm (n=360). At the point of the interim review, PFS did not appear significantly improved compared to the comparator arm. Results from a second trial in the nintedanib LUME-Lung program will be presented on June 3 at ASCO.