Merck Serono, the biopharmaceutical division of Merck, has announced the decision to continue clinical development of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) under a new Phase III trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).
This announcement is based on the outcome of the START trial. The START trial did not meet the primary endpoint of improving overall survival (OS) in the overall patient population. Data from an exploratory analysis of a predefined subgroup of patients in the START trial, who received tecemotide after concurrent chemoradiotherapy (CRT), showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64–0.95; p=0.016). Concurrent CRT is a combination of chemotherapy and radiotherapy given at the same time.