Risk of Pivotal Study Failure Rises for NewLink and Northwest Bio

 NEW YORK (TheStreet) -- NewLink Genetics (NLNK) and Northwest Biotherapeutics (NWBO) announced results from interim analyses of their respective phase III cancer studies Friday. Both studies continue as planned. Good news? Not really. Let's discuss.

The NewLink phase III study of its HyperAcute Pancreas (HAP) vaccine is designed with overall survival as the primary endpoint. The first interim analysis was conducted after the 222nd patient death was reported, or half the number of deaths needed to conduct the final analysis.

To stop the study successfully at the first interim analysis, HAP needed to demonstrate a 40-45% improvement in median overall survival compared to placebo. As with all interim analysis, the statistical bar was set high.

NewLink announced Friday that the HAP pancreatic cancer study would continue unchanged, based on a review of patient data by independent monitors. Onward to the second interim analysis, planned for 330 deaths.

"As we have previously emphasized, continuation of this study was an anticipated outcome considering the high statistical threshold assigned to this first interim analysis under the special protocol assessment," said NewLink CEO Charles Link, in a statement.

Really? Sounds like a lot of spin. Investors who have met with NewLink (and talked to me) say management was much more confident in HAP demonstrating a statistically significant survival benefit at the first interim than they let on today. Remember, NewLink originally told investors the first interim analysis would take place last summer. The delay (patients are taking longer to die!) suggested HAP was working because control arm patients couldn't be living longer, or so the NewLink bulls claimed.

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