Merck Serono Ph III trial of L-BLP25 fails endpoint in NSCLC

Merck Serono, a division of Germany’s Merck KGaA (MRK: DE), announced detailed results from the randomized Phase III START trial of its investigational MUC1 antigen-specific cancer immunotherapy L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC), showing the drug failed to meet its primary endpoint.

These results will be presented at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago. The primary endpoint of improving overall survival (OS) was not met. In a predefined subgroup of patients receiving initial concurrent chemoradiotherapy (CRT), a combination of chemotherapy and radiotherapy given at the same time, a median overall survival of 30.8 months versus 20.6 months was observed based on a post hoc analysis in patients treated with L-BLP25 versus placebo respectively (HR 0.78, 95% CI 0.64–0.95, p=0.016, n=806).

In a post hoc analysis of the predefined subgroup of patients receiving initial concurrent CRT (n=806), patients receiving L-BLP25 had a median OS of 30.8 months compared to patients receiving placebo, who had a median OS of 20.6 months [HR 0.78; 95% CI 0.64–0.95; p=0.016]). In patients receiving sequential CRT followed by L-BLP25 or placebo a median OS of 19.4 months was observed for the L-BLP25 group compared with 24.6 months for the placebo group (n=433; HR 1.12; 95% CI 0.87–1.44; p=0.38). Predefined subgroup analyses included, among others, disease stage (IIIA or IIIB), response to initial CRT (stable disease versus objective response), type of initial CRT (concurrent versus sequential) and geographic region.