>> from the look of the k-m curves, it looks clear that the lack of PFS improvement isn't simply due to a consideration of a single point. <<
The PFS HR of 0.85 and the OS HR of 0.66 are not so far apart as to be alarming, IMHO.
On the R&R webcast, YMI’s CEO said that, after the drug showed no benefit in RR relative to placebo, no one in the industry believed the OS results. If that’s an accurate description, it’s surprising because you would expect industry experts to recognize the shortcomings of RR as an efficacy metric.
It seems that the predictive value of RR is now routinely discounted in “targeted” therapies such as Tarceva, but RR is still believed to be predictive of survival for cytotoxics. Perhaps this conventional wisdom needs to be updated.
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