>ECYT
One point in their defense was that the OS numbers were for the ITT group, not the FR++ subgroup. The drug combo clearly did worse than the control group in the FR- subgroup (PFS HR of 1.81 in the subgroup vs 0.63 in the ITT group). This group, although fairly small, is expected to have a better prognosis, and so might have more influence on OS than their raw numbers might indicate. (But I concede they might well have presented the subgroup OS numbers if they were favorable).
Given the shape of the curve (still around 20% survival in the drug group at 35 months), I suspect that if you wait until the data is fully mature you would get an OS HR of a bit under 1.0. (The last figure I saw was 1.01).
The control group did do surprisingly well for a purportedly platinum-resistant population. But it's under 50 patients, so a handful who did well can skew the numbers quite a bit.
In a recent presentation they did say that they "feel good" about their interactions with the EMA, for whatever that is worth.
Peter
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