Stimuvax fails to meet primary endpoint in NSCLC-Merck Serono

The Lancet Oncology has published results from the Phase III trial of Stimuvax (tecemotide) (L-BLP25), from Merck Serono, in patients with unresectable, locally advanced Stage III Non-Small Cell Lung Cancer (NSCLC), known as the START trial. Data showed that the primary endpoint of overall survival (OS) was not met. Median OS was 25.6 months for patients in the tecemotide group compared with 22.3 months for those in the placebo group. The publication includes an exploratory analysis of a predefined subgroup of patients in the START trial who received tecemotide after concurrent chemoradiotherapy (CRT). Patients in this subgroup achieved a median OS of 30.8 months vs. 20.6 months in patients treated with placebo. In patients receiving sequential CRT followed by tecemotide or placebo a median OS of 19.4 months was observed for the tecemotide group compared with 24.6 months for the placebo group.

Merck Serono will continue the development of tecemotide under a new Phase III trial called START2, based on the results of the START trial. The START2 trial is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent CRT. See: "Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial" Charles Butts et al. The Lancet oncology 9 December 2013 doi:10.1016/S1470-2045(13)70510-2