One aspect that may be in Tarceva's favor with respect to the ISEL trial is smokers. Goddard has mentioned that Tarceva is cleared faster in smokers than in nonsmokers; possibly a reason for the lower efficacy in this group. Rapid clearance of the drug really hits Iressa harder than Tarceva, since Iressa has a lower affinity for the EGF-R target.
Although Tarceva didn't show great efficacy for smokers (HR = 0.87), if Iressa bombs on this subpopulation, it could account for the small difference that OSIP needs at this point to shed itself of the Iressa shadow.
And after looking at the participating countries, I feel pretty good about there being sufficient smokers in the ISEL trial