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Oncothyreon routed after Merck KGaA's Stimuvax flops in PhIII lung cancer trial

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After taking its big Phase III study of Stimuvax all the way to a conclusive finish, Merck KGaA said the closely-watched lung cancer vaccine failed to demonstrate a significant improvement in overall survival--a flop that will leave a deep scar at Oncothyreon ($ONTY) as well, which licensed out the treatment. Without providing many details, though, the German pharma giant offered that "notable treatment effects were seen for L-BLP25 (Stimuvax) in certain subgroups," holding out some hope that the program isn't completely dead.

Merck KGaA invested heavily to test Stimuvax in a patient population of 1,500 suffering from non-small cell lung cancer. Investors were badly rattled back in March when investigators failed to see enough positive evidence of efficacy after 75% of the planned patient "events" had been recorded, forcing investigators to take the study all the way to the end and sending shivers down the spines of small investors who had bet on the Oncothyreon program.

Oncothyreon shares immediately cratered on the news, with its stock plunging 66% in premarket trading to a mere $1.51 a share. Shares of Merck KGaA slid 3.5% on the news, though at this stage some analysts had clearly given up much hope of success.

"Given the history of the drug development with postponements, discontinuations and break-ups we are not surprised about today's outcome," DZ Bank analyst Peter Spengler noted, according to a report from Reuters.

Next step: "explore the potential benefit-risk profile of L-BLP25 in certain populations."

Even under the best of circumstances, though, these kinds of follow-on programs can take years and require a significant amount of additional trial work, a bleak prospect for drug developers often seen as more of a fig leaf to avoid the admission of complete defeat. 

"Without Stimuvax, $ONTY now becomes a (much cleaner, more traditional, small molecule biotech) story about PX-866, the wholly-owned, oral, irreversible, inhibitor of PI3K, which is currently in five Phase II trials, three in combination (with Erbitux, Docetaxel and Zelboraf) and two monotherapy trials, in six solid tumors, with data expected to start reading out late 1Q/early 2Q 2013," noted Cowen's Simos Simeonidis this morning.

"It is disappointing that the START trial did not meet its primary endpoint, in particular for patients suffering from NSCLC," said Dr. Frances Shepherd a professor at the University of Toronto and coordinating investigator of the START trial. "However, notable treatment effects were observed in certain subgroups of patients and warrant further investigation of L-BLP25."

The whole field of therapeutic cancer vaccines has gone through a roller coaster ride of sorts, triggering hopes of amazing breakthroughs and blockbuster revenue before the weak rollout of Provenge tempered expectations. But more recently there has been a surge of renewed interest in these experimental programs as some big operations look to add new therapies to the mix in the fight against cancer. 

- here's the press release
- read the report from Reuters

Special Report: 10 promising therapeutic vaccines 2012

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