The SEC disclosure is only two sentences long, and on the surface doesn't seem that bad:
"On March 6, 2012, Merck Serono, a division of Merck KGaA of Darmstadt, Germany, informed Oncothyreon (Nasdaq: ONTY ) that the Independent Data Monitoring Committee (DMC) for the phase 3 START trial of Stimuvax in non-small-cell lung cancer (NSCLC) met and the DMC recommendation is to continue the study. Final results from the study are expected in 2013."
Trial continuing, results next year, what's the big deal? It's that investors were hoping for the data now, today, instantly after the DMC took an interim look at the data, and the delay sent shares of Oncothyreon down 40%.
Ironically, longer cancer drug trials are usually viewed as a good sign for a company. Keryx Biopharmaceuticals' (Nasdaq: KERX ) and Aeterna Zentaris' (Nasdaq: AEZS ) investors, for example, are hoping a longer trial is a sign that the biotechs' drug candidate, perifosine, is keeping colon cancer patients alive longer.
But when a company builds an interim look into their trial, there's a hope that the trial will be stopped early because the drug is working so well. The lack of an early conclusion also breeds worries that the trial will ultimately fail, which likely contributed to the stock plunge today.
But the way that interim peeks at clinical trial data work is that there's a higher statistical threshold required to stop the trial early, because each time you look at the data, you increase the likelihood of finding what you're looking for. So Stimuvax didn't work really well, but it's still possible that the drug works well enough to ultimately pass the trial when more patients report out next year.
Stimuvax doesn't need superb survival data to get on the market and have meaningful sales. NSCLC patients have few options, and Merck KGaA and Oncothyreon are testing Stimuvax after chemotherapy so it won't have to compete with those drugs. Just barely passing its clinical trial with an incremental increase in survival will be good enough.
On the other hand, there's a reason there a few options: NSCLC is one tough cookie. Beyond Pfizer's (NYSE: PFE ) Xalkori, which treats only patients with a certain mutation, I can't think of any drugs approved to treat lung cancer recently. Oncothyreon is still a risky stock to own, but it's just got a heck of a lot cheaper.