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Oncothyreon Announces That L-BLP25 (Stimuvax®) Did Not Meet Primary Endpoint Of Improvement In Overall Survival In Pivotal Phase 3 Trial In Patients With Non-Small Cell Lung Cancer

Stocks in this article: ONTY

Company to Hold Conference Call at 8:30 am EST Today

SEATTLE, WA, Dec. 19, 2012 /PRNewswire/ - Oncothyreon Inc. (Nasdaq: 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 advice on potential next steps," said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck Serono. The ongoing clinical program of L-BLP25 that includes studies in the Asia Pacific region will continue pending discussion with relevant regulatory agencies.

START was a randomized, multicenter, double-blind, placebo-controlled trial that assessed the efficacy, safety and tolerability of L-BLP25 in patients with unresectable stage III NSCLC who achieved a response or stable disease after chemoradiotherapy. Patients were randomized to receive either a single low dose of cyclophosphamide followed by L-BLP25 (weekly injections for eight weeks followed by injections every six-weeks until progression) plus best supportive care (BSC) or placebo plus BSC. More than 1,500 patients from 33 countries were recruited into the START trial.

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