Without sharing interim data to prove a win for NewLink Genetics' late-stage pancreatic cancer vaccine, it will go full steam ahead on its Phase III trial, the company announced Monday.
The IMPRESS trial for algenpantucel-L--or HyperAcute pancreas--will continue with no changes following the second planned interim analysis for the trial. The analysis was tied to 444 "patient events," which typically means deaths.
In March 2014, the company conducted the first interim analysis of the trial, tied to 222 patient deaths. Many expected algenpantucel-L to reach 222 deaths earlier than it did, which fed investor hopes that the vaccine was working and that the trial could finish early. However, no convincing efficacy data was reported and the trial continued.
NewLink ($NLNK) shares dropped 20% in after-hours trading. Still, execs expressed optimism over algenpantucel-L, the company's lead candidate. "We look forward to bringing this study to its planned endpoint, as algenpantucel-L has the potential to be the first and only FDA approved drug for resected pancreatic cancer, providing additional treatment options to patients, their families and physicians," said Dr. Nicholas Vahanian, president and chief medical officer of NewLink, in a statement.
But as time ticks on, the likelihood that NewLink's candidate will join the long list of failed cancer vaccine forays grows. 2014 saw some late-stage failures, including Merck KGaA and GlaxoSmithKline's ($GSK) non-small cell lung cancer candidates both missing. Several companies have tried to dig themselves out of the troubled cancer vaccine field by testing their vaccines in combination with another drug. These include Bavarian Nordic, which is testing its Prostvac in combination with Bristol-Myers Squibb's ($BMY) Yervoy, and Amgen ($AMGN), which is testing its T-Vec with Merck's ($MRK) Keytruda.
- here's the release
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