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jq1234

05/23/12 6:04 PM

#142456 RE: Summer2762 #142434

If I were them, I would take Met+ to ph3:

Met + 2.9 1.5 0.43 0.19-0.97 0.03


If it was due to disappointment to the result, I think the expectation was too high. This is HCC that failed Nexavar, where nothing really works. For advanced HCC without systematic treatment, Nexavar got the following:

5.5 2.8 0.58 (0.45, 0.74) 0.000007

biomaven0

05/24/12 1:21 PM

#142535 RE: Summer2762 #142434

The issue is that the median TTP & PFS are ~6wks. RECIST by CT / MRI is also every patient ~6wks. So any patient who did not progress by 6wks checkup is bumped to 12wks. So the HR numbers are artificially inflated by the near binary nature of the measurements. You can easily visualize how the KM graphs look like in both cases.



That's a very interesting point. You'd see a scalloped KM curve, which is potentially particularly tricky with a scallop right near the median. I was wondering how you could get such a good HR with such a small increase in TTP.

But their preliminary HR on OS is still very good. Maybe the crossover won't make such a difference because these patients just don't have much time after confirmed progression.

BTW, I noted a higher PFS (1.7) than TTP (1.6) in the ITT drug group. How is that possible?

Peter