Merck: Phase III Trial of L-BLP25 in patients with non-small cell lung cancer did not meet primary endpoint
Merck announced that the Phase III START(a) trial of its investigational product L-BLP25 (formerly referred to as Stimuvax®) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival.
Despite not meeting the primary endpoint, notable treatment effects were seen for
L-BLP25 in certain subgroups. Patient safety in the START trial was monitored frequently by an independent data monitoring committee and 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.
Further analyses are planned in the coming weeks to explore the potential benefit-risk profile of L-BLP25 in certain populations.
The ongoing clinical program of L-BLP25 that includes studies in the Asia Pacific region will continue pending discussion with relevant regulatory agencies.
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.
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