Bavencio misses in Phase III for NSCLC

Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) said Bavencio avelumab missed the primary endpoint in the Phase III JAVELIN Lung 200 trial to treat locally advanced, unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) in patients whose disease progressed after treatment with a platinum-containing doublet therapy.

On the 792-patient trial's primary endpoint, 10 mg/kg IV Bavencio every two weeks failed to significantly improve overall survival (OS) in PD-L1-positive patients vs. docetaxel (HR=0.9, 96% CI: 0.72, 1.12, one-sided p=0.1627). The partners said the result may have been confounded by the higher proportion of docetaxel patients who subsequently received treatment with checkpoint inhibitors outside of the trial compared to previous post-platinum immunotherapy clinical trials...