Gil Roth12.09.13
Merck Serono has published results from the Phase III trial of its investigational MUC1 antigen specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC), known as the START* trial, in The Lancet Oncology.
Data included in the publication, and first presented at the American Society of Clinical Oncology (ASCO) 2013, 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 (n=806; HR: 0.78; 95% CI 0.64-0.95; p=0.016). 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 (n=433; HR 1.12; 95% CI 0.87-1.44; p=0.38).
Merck Serono will continue the development of tecemotide under a new Phase III trial based on the results of this one. The new 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. The trial's primary endpoint is OS. Merck has received Scientific Advice from the European Medicines Agency (EMA) on the program, and has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the international trial.
Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy designed to stimulate the body's immune system to identify and target cancer cells expressing the cell-surface glycoprotein MUC1. MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumor growth and survival.