Oncothyreon Reports Merck Serono Decision to Continue Development of Tecemotide

Oncothyreon Inc.

today announced that Merck Serono, the biopharmaceutical division of Merck KGaA, has decided to continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25 and formerly known as Stimuvax®).  Merck Serono, which is developing tecemotide under a license agreement with Oncothyreon, will conduct a new Phase 3 trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). This decision is based on the outcome of the prior START trial. While 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, 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. START2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients with unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who