Update on two NeuVax trials

Hopeful82014

• Galena Biopharma Reports Positive Outcome from the Data Safety Monitoring Board on the Two NeuVax™ (nelipepimut-S) Clinical Trials in Combination with Trastuzumab
• Both combination trials are deemed not futile and Data Safety Monitoring Board recommends that both trials continue
• Interim efficacy analysis for the low-to-intermediate (HER2 1+/2+) trial now expected by the end of 2017

muska

Can somebody please clarify for me what this statement means: "It is important to note that these IST trials are designed with a different methodology to identify recurrences clinically and not via proactive imaging as was done in the PRESENT trial. "

They shortened the interim efficacy analysis milestone and will only check for symptoms of recurrences without running any imaging scans? Am I reading this correctly? Doesn't that mean they will be seeing much fewer recurrences than if they were doing the analysis further down the road and after imaging scans?

Here is the link: http://finance.yahoo.com/news/galena-biopharma-reports-positive-outcome-120500269.html

Hopeful82014

Bear in mind, Muska, that it's the interim efficacy analysis that's being moved forward by 6 months. The study follows participants for 10 years and assesses for DFS & OS at 3,5, and 10 years. By the end of 2017 the earliest participants will have at least 5 years from start of the trial under their belts. So it's not as though they're cutting back significantly, in my opinion.

As to the methodology (clinical vs. imaging) - I'm not sure why they would do that although I can speculate. I'd prefer to see the latter (identification by imaging).

ETA: Apparently the link I provided is not functioning. Muska's link is, however, and provides the same information.