Merck Serono NSCLC vaccine candidate fails to meet primary endpoint in Ph III

Merck Serono, a division of Germany’s Merck KGaA (MRK: DE), Darmstadt, says that the Phase III START trial of its investigational vaccine product L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS).

However, the company notes, despite not meeting the primary endpoint, notable treatment effects were seen for L-BLP25 in certain subgroups. Nevertheless, Merck’s shares fell 3.1% to 98.20 euros following the announcement yesterday morning.

Patient safety in the START trial was monitored frequently by an independent data monitoring committee and no new or unexpected safety concerns were noted for the study. In prior clinical studies, the most frequently reported adverse events included injection site reactions, flu-like symptoms, nausea, cough, fatigue, and dysponea.