Biotech Values

[walldiver]

>>Provenge arm 26.3 months
placebo crossovers 23.9 months
placebo noncrossovers 19.3 months<<

"Not sure in this case, but don't noncrossovers often do worse than crossovers in trials because at the time they were allowed to crossover they were ... (i) dead or (ii) in very bad shape or (iii) simply not fighting as hard as the crossovers for a few extra months of life?"

The patients prior to being randomized into the placebo or treatment arm had to choose whether to cross over or not. I believe that for most patients in the trials, progression occurred within three to six months after randomization. So whenever it was deemed that an individual had progressed, the blind was subsequently broken and the placebo pts who had opted for crossover were then administered the frozen Provenge soon afterward.

Why didn't the Provenge patients die sooner, once they found out they had progressed? Was it because they went to chemo faster? Nope. The FDA stated in the briefing docs that overall, the patients in the Provenge arm did not receive earlier chemo than the patients in the placebo arm. So how else can the laddered improvement from Provenge-naive, to salvage Provenge, to Provenge treatment arm be explained?