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Oncothyreon Reports Merck Serono Decision to Continue Development of Tecemotide


Oncothyreon Inc. (NASDAQ: ONTY) 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

See full press release

Posted-In: News Guidance Contracts Management Global


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