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acgood

11/29/11 10:23 PM

#132064 RE: mcbio #132062

ARRY - serious question...

I don't follow ARRY closely, so forgive if this comes off as glib. But is there differentiation among the three MEK inhibitors? Shouldn't one be their best shot at this target?

I am reminded of teams that have three quarterbacks or three closers - which of course means they, in fact, have none.
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iwfal

11/30/11 4:04 AM

#132078 RE: mcbio #132062

ARRY -

Would you care to wager a guess on how likely it is this trial could show stat sig OS benefit for the selumetinib arm if the DTIC control arm shows the same 8 months OS numbers (no guarantee and clearly an assumption here) given length of time the trial has been fully enrolled and fact that they still haven't reached the trigger?



If it is 2:1 enrollment then a Jan trigger implies approx 10.5 blended median OS - and if placebo is 8 months then treated is about 11.75 months. I.e. HR=~0.67. Which is not stat sig with just 60 events.

If it goes to Jun (and has a blended median of 12 months) then the HR is about 0.57 - which is stat sig but only barely.

Caveat - the so few events the medians are extremely noisy (i.e. not representative of the average hazard for the curve) so my above comments are really more of an answer to a transmutation of your question (would the trial be stat sig if the average hazard of the placebo curve were the same as the hazard in an exponential curve with a median of 8 months)