You are here

Lung Cancer Drug Fails Phase III Trial

No improvement in survival with antigen-specific immunotherapy (Dec. 19)

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs