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caravon

10/01/12 12:45 AM

#149707 RE: mcbio #149706

The CEO mentioned that the 375-pts event took place sometimes in mid July 2012.

"The mOS for the erlotinib control arm is assumed to be 7 months."

The PhII placebo-arm had just 6% of KRAS-mutant pts. These pts have just 2.5 months mOS in the 1st-line pts. There are ~25% of KRAS-mutant pts in a general NSCLC population. ARQL mentioned that PhIII pts population would model the "real life" or mKRAS is expected to be ~ 25%.

MARQUEE's much higher mKRAS population could bring the erlotinib control arm mOS to under 6 month.

My "on a top of an envelop" calculations for the 7-months the erlotinib control arm mOS would bring the the 375-pts event to mid August for the 2-months control/drug arms mOS separation. The 6-months erlotinib control arm mOS would bring the the 375-pts event to mid July for the same 2-months control/drug arms mOS separation.

PS
It is very puzzling to me why MARQUUE trial has mEGFR pts population.