<<I'm impressed that the discontinuation arms diverged to the level of "statistical significance".>>
Maybe! But, is this difference due to continuous drug benefit (further stabilization), or due to “speculations” (or facts???) that placebo arm is somehow “hurt” by primary drug effect from first 12 weeks run in : rise in receptor ligands (cytokines, growth factors, …) levels as contra-balance to drug actions? As you know, after any action on receptor (sometimes companies are talking about decrease in the receptors expression level, from baseline) surge in ligand level develop shortly after. They need long term drug saturation to produce positive effect by receptor blockade.
So, what they did demonstrated by PII trial designee is that once you put person on drug, it is better to keep it on, regardless does drug have any true effect or not. Or, do not try drug at all.
Why they are holding TTP data for randomized group?
Overall objective response rate is very low, ~4%, but this does not tell you anything about survival. Overall TTP sound OK, but without control arm it is hard to compare data to those from with competitive drug (Avastin and 11248). Anyway, single agent for second line RCC is not the best choice, imo. It is an easy way to show difference from control arm (placebo), but the weight and value of data generated may be not so convincing. Again, company is silent about PIII statistics, so I think that FDA did put high bar (% difference in OS) for PIII.
<<So...... not that Bayer has even thought about it, but would Onyx management agree to a buyout at 40? 38? 42? >>
Definitely, they will. The question is who will buy? Bayer failed early with in-house Fernesyl transferase inhibitor. This is their best shot! But, is the best shot the right shot?
As I said, very hard to read data. I do believe that drug is active, up to the point that it may reach market. However, it may not sell as well as on will hope for.
Miljenko |
