Phase III trial of Stimuvax (Merck Serono) fails to meet primary endpoint in patients with NSCLC

The Phase III START study, a trial of L-BLP25 (formerly called Stimuvax), from Merck Serono, in patients with unresectable, locally advanced stage IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC) failed to meet its primary endpoint of demonstrating a statistically significant improvement in overall survival. No new or unexpected safety concerns were noted for the study. In prior clinical studies, the most frequently reported adverse events included injection site reactions, flu-like symptoms, nausea, cough, fatigue, and dyspnea.

START was a randomized, multicenter, double-blind, placebo-controlled trial that assessed the efficacy, safety and tolerability of L-BLP25 in more than 1,500 patients with unresectable stage III NSCLC who had achieved response or stable disease after chemoradiotherapy.