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Re: DrRocker post# 121382

Tuesday, 05/07/2013 10:52:51 AM

Tuesday, May 07, 2013 10:52:51 AM

Post# of 345554
The only thing that matters is the increase in MOS for the treatment arm compared with the control arm.
There is no way to know if the disclosed PFS results will have any connection with the expected MOS results.
I am not even sure if it is possible to say that you could expect the first-line results to be better than the
second-line results. That would be true if you were talking about a trial comparing two chemotherapy regimens,
but we are not. Bavi is an immunotherapy and I can conceive of reasons for the second-line to be better than
first-line therapy, but to still expect very good first-line results. We know very little about the first-line trial.
We do not know anything about the patient characteristics. We do not even know what ECOG PS scores
are allowed. PS 0-2, or 0-1? The clinical trials webpage does not list this in the inclusion/exclusion criteria.
http://www.clinicaltrials.gov/ct2/show/NCT01160601?term=Bavituximab+OR+Peregrine&rank=4
Given all of this my expectations are for control MOS of 10 months and treatment MOS of 14-15 months.
I believe that Peregrine is waiting until approximately 80% of the treatment arm patients have died before announcing
the MOS results. This will eliminate second guessing about the effect censored patients would have on the ultimate result.
I also believe that the results will not be statistically significant because of the small trial size, but this is to be expected.
However, I do expect a good result for the hazard ratio. Remember that this is a phase IIb trial, not a phase III trial.
There is a big difference in expectations between the two.
Note that an increase of MOS of 40% would still be excellent and much better than the 19.4% seen in the Avastin + CP first-line NSCLC trial.
Here is an updated chart including 20 Phase III first-line NSCLC trials which had a control arm using carboplatin + paclitaxel (CP).

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