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Saturday, February 23, 2013 10:31:50 AM
1) The PS scores in the phase IIa trial were PS 0 = 4%, PS 1 = 96%. As we have seen the PS score is
a major cofactor for survival. Most first-line NSCLC trials I have looked at have nothing like that
distribution, which means a more "normal" PS distribution would increase the survival.
2) The amount of carboplatin and paclitaxel used in the phase IIa trial was less than used in
the current phase IIb trial. This too should increase survival by some smaller extent.
3) The trial design can also be a factor. The first trial had a two-stage design. I don't know to
what extent this may have impacted the survival, but it is possible that it did.
4) The first trial was a single-arm trial, so we don't know how it would compare with a control arm with a
similar patient population.
There may be other factors, but these are enough to make it reasonable to expect a longer MOS.
Mojojojo's estimate was a range from 17.1 to 18.7 months, even the low end here is very good if the
control arm is around the historic mean of 9.8 months. I would think anything >50% would be a home run.
I should add that the results of the second-line NSCLC trial showed a doubling of MOS (at least in my mind),
or 60% officially. That should be a better indicator than the pancreatic trial.
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