Improved overall survival prompts new Phase III study for Merck Serono
Merck Serono, the biotech unit of Germany’s Merck KGaA (MRK: DE), will 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 which did not meet the primary endpoint of improving overall survival 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), is a combination of chemotherapy and radiotherapy given at the same time, showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo.
Study details
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