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Lung Cancer Drug Fails Phase III Trial
The investigational lung cancer compound L-BLP25 (formerly known as Stimuvax; Oncothyreon Inc.) failed to meet the primary efficacy endpoint of improved overall survival in a pivotal phase III trial involving patients with unresectable, locally advanced stage IIIA or IIIB non–small-cell lung cancer (NSCLC).
The START trial was a randomized, multicenter, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of L-BLP25 in patients with unresectable stage III NSCLC who had achieved a response or stable disease after chemoradiotherapy. More than 1,500 patients were randomly assigned to receive either a single low dose of cyclophosphamide followed by L-BLP25 (weekly injections for 8 weeks followed by injections every 6 weeks until progression) plus best supportive care (BSC) or placebo plus BSC.
In previous clinical studies, the most frequently reported adverse events associated with L-BLP25 included injection-site reactions, flu-like symptoms, nausea, cough, fatigue, and dyspnea.
L-BLP25, which has been under development for more than a decade, is an investigational mucin 1 (MUC1) antigen-specific cancer immunotherapy that is designed to stimulate the body’s immune system to identify and target cells expressing the cell-surface glycoprotein MUC1. MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in promoting tumor growth and survival.
Source: Oncothyreon; December 19, 2012.