Perhaps you have heard the Stimuvax statistical setup of the trial before, but I hadn't. Interesting assumptions of 20 month survival advantage for control, 90% powered, capable of 6 month survival advantage.....any comments from the pros on how we can reverse engineer that info better.
I will not pretend to understand all the statistical information. I am well versed in technical stats, but not in biomedical stats.
My question to the experts: If the trial is said to be able to statistically see a 6 months survival advantage, then could we not start to get confident in the trial when the total population starts to see 24 months survival (20 month + 6 month advantage for stimuvax and 20 months for the control = weighted avg of 24 months). I realize that potentially the trial may still have to go to the end if it was a close call, but I am thinking somewhere around 24 months plus 4 more months for data review (from the point when we have enough enrolled for the 2nd event look) and we haven't heard anything, then we should start doubling down. I know ramp up on enrollment might make the math not as straight forward.
There was no phase I in breast with stimuvax but its sister compound theratope had all three phases, I,II and III. There was activity with theratope and some promise in exactly the same subset Merck was recruiting for STRIDE.
The only case of encephalitis which may have been linked to stimuvax was in the Multiple Myeloma trial.
There were NO other cases in any trials with thousands of enrollees and although there is no way of proving it, most researchers do not believe stimuvax was involved.