Oncothyreon ONTY today
announced that the pivotal Phase 3 clinical trial of L-BLP25 (formerly
referred to as Stimuvax®) known as START did not meet its primary endpoint of an improvement in
overall survival in patients with unresectable, locally advanced stage
IIIA or stage IIIB non-small cell lung cancer (NSCLC). The trial was
conducted by Merck Serono, a division of Merck KGaA of Darmstadt,
Germany, under a license agreement with Oncothyreon.
Despite not meeting the primary endpoint, notable treatment effects were
seen for L-BLP25 in certain subgroups. Further analyses are planned in
the coming weeks to explore the potential benefit-risk profile of
L-BLP25 in certain populations. Merck Serono will discuss these data
with external experts and regulatory authorities over the coming
months. More detailed results from the START trial will be submitted
for publication in a peer reviewed journal and presentation at upcoming
scientific meetings.
"We believe that the START study will offer important scientific
insights to the potential for immunotherapies in the treatment of this
devastating disease and we intend to discuss these data with scientific
community and regulatory authorities to gain their
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