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Re: jbog post# 4353

Thursday, 10/04/2007 2:47:24 PM

Thursday, October 04, 2007 2:47:24 PM

Post# of 4764
Good analysis jb. Just a few quick additions

First your calculating the improvement in OS by (difference in median OS/control arm median OS) Which is the improvement of median survival not Over all survival. For example a HR=.8 is a 25% improvement in OS. ((1/.8)-1)x100=25%

But you are consistent throughout your note so the relative changes should all be accurate and not change the essence of your comparision.

Also you didn’t include BMS 100 trial in your write up. That was a very positive phase 2 trial using platinum/gemcitabine with/without erbitux with 131 patients.
+ Erbitux vs – Erbitux
RR 28% vs 18%
Med OS 12mo vs 9.25 mo
Med PFS 5.1 mo vs 4.2 mo
1 yr survival 50% vs 38%
OS Hazard ratio = 0.77 (not reported, my estimate)
PFS Hazard ratio = 0.84 (not reported, my estimate)

If the FLEX survival data matches BMS100 then erbitux has a grand slam in lung cancer and will take market share away from avastin. Especially since the patient population in FLEX was much sicker than Avastins pivotal trial.

If the FLEX survival data is simialar to LUCAS (14% improvement in median survival) I still believe you have a clinically relevant improvement, probably much more so in some of the subgroups than others. And sales in lung cancer could still be huge (over $500M).

Got to run, Thursday is golf day for me.





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