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jq1234

12/09/12 11:11 PM

#153824 RE: p3analyze #153821

I have to think about what the median OS of 11.3 months for the 5 IC nonTN HG patients which I estimated with fairly good precision from graphs 3&4 meant. They are clearly not outliers with 2 of them died before 7 months and the remaining 3 pts that survived longer than 11 months vs 9 to 10 IC nonTN and nonHG pts.



I replied in a separate post a little bit on those 3 patients. Based on N difference between OS and PFS, two patients in high G and TN IC arm are crossover, 5 in high G IC arm are crossover, thus 3 high G nonTN are crossover. If those 3 patients or two out of three in IC arm with OS 11.3m, 12.3m, 21m are crossover, it would be very easy to explain away your concern.

Not to pursue high G itself at this point is a good decision IMO. Focus on the most likely to succeed with the smallest possible ph3 trial. Even if crossover explains your concern, I would not go to ph3 with high G at this point until after exploring higher than 25% cutoff for GPNMB.