Merck Serono pulls plug on tecemotide in Stage III NSCLC

Merck Serono, the biotech unit of Germany’s Merck KGaA (MRK: DE), is to discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy for stage III non-small cell lung cancer (NSCLC).

The decision to discontinue the current clinical program follows recent results of EMR 63325-009 in 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 chemo-radiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation. Results indicated that no effect was observed for the primary endpoint, overall survival, or for any secondary endpoints, such as progression-free survival and time to progression.

Luciano Rossetti, global head of R&D at Merck Serono, said: “While the data from the exploratory subgroup analysis in the START trial1 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. Therefore, we have decided to discontinue the development of tecemotide as a monotherapy in NSCLC in order to refocus our efforts on other promising candidates in our pipeline, like our anti-PD-L1 antibody MSB0010718C. Merck Serono remains committed to developing new treatment options for patients with difficult-to-treat cancers.”