Merck initiates Phase III trial of Stimuvax for NSCLC - Merck

Merck KGaA has initiated the international Phase III START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy Stimuvax (tecemotide, also known as L-BLP25) in patients with unresectable, locally advanced Stage III Non-Small Cell Lung Cancer (NSCLC). The START2 study is a multicenter, 1:1 randomized, double-blind, placebo-controlled clinical trial 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 chemoradiotherapy (CRT).

The primary endpoint is overall survival (OS). Secondary endpoints include time to symptom progression, progression-free survival and time to progression. START2 is based on the outcome of the prior START trial. While the START trial did not meet the primary endpoint of improving OS in the overall patient population, data from an exploratory analysis of a predefined subgroup of patients, who received tecemotide after concurrent CRT, showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo.