MUC1 is a mucinous
glycoprotein which is overexpressed and under or aberrantly glycosylated in many human
malignancies. MUC1 is associated with cellular transformation and can confer resistance to genotoxic agents.
L-BLP25 is a
peptide vaccine strategy that targets the exposed core
peptide of MUC1. In preclinical studies,
L-BLP25 induced a cellular immune response characterized by T-cell proliferation in response to MUC1 and production of IFN-gamma. Phase I and II trials have established the dose and schedule of the
vaccine as well as its excellent safety profile. A randomized phase II trial of maintenance
L-BLP25 versus best supportive care in patients with stage IIIB/IV
non-small cell lung cancer who experienced clinical benefit from initial
therapy has been reported. Updated survival analysis of this trial continues to show a strong survival trend in favor of
L-BLP25 (median survival, 30.6 versus 13.3 months) in a subgroup of patients with locoregional stage IIIB disease. These promising results will be tested in a phase III trial of
L-BLP25 versus placebo in patients with stage III
non-small cell lung cancer after response to primary
chemoradiotherapy.