Program for Stimuvax in NSCLC discontinued-Merck Serono

Merck has announced that its biopharmaceutical division Merck Serono will discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy Stimuvax (tecemotide), also known as L-BLP25, as a monotherapy in Stage III Non-Small Cell Lung Cancer (NSCLC).

The decision to discontinue the current clinical program in NSCLC, which includes the Phase III START and INSPIRE studies, follows recent results from a planned analysis of EMR 63325-009, a Phase I/II study in Japanese patients with locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy. Of the patients included in the Phase II part of the study, the majority had received concurrent CRT. The results indicate that no effect has been observed for either the primary endpoint, overall survival, or for any of the secondary endpoints (progression-free survival, time to progression and time to treatment failure).