Merck Serono Ends Tecemotide Development Application

Merck Serono, the biopharmaceutical division of Merck KGaA has decided to discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).

The company said the decision to discontinue the current clinical program follows recent results from a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled Phase I/II study in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose ≥50 Gy. Of the patients included in the Phase II part of the study, the majority had received concurrent CRT.

According to Merck, the results indicate that no effect has been observed for either the primary endpoint, overall survival (OS) or for any of the secondary endpoints (progression-free survival [PFS], time to progression [TTP] and time to treatment failure). An analysis of the reported adverse events had not identified a clinically meaningful difference in the frequency between treatment groups.

Luciano Rossetti, global head of research & development at Merck Serono, said that while the data from the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals.