ImClone Systems Inc (formerly IMCL)

[DewDiligence]

>Do you happen to recall whether the Merck KGaA [FLEX] trial is sufficiently powered to look for a meaningful response difference in the Squamous subset?<

My guess is that FLEX is stratified by disease subgroup (including the squamous subgroup) but is not powered to show a statsig survival benefit in the squamous subgroup or in any other subgroup. Moreover, if the trial fails to attain a statsig outcome in the overall population, a statsig outcome in the squamous group would be considered hypothesis generating rather than a finding that could support approval in the squamous subgroup, specifically.

On the other hand, if FLEX does attain a statsig outcome for the overall population, it should allow Erbitux to get a label for first-line NSCLC that includes the squamous subgroup, even if the p-value for the squamous subgroup misses. (If the overall trial succeeds and the p-value for the squamous subgroup hits, so much the better.)

This is the FLEX study description from clinicaltrials.gov:
http://www.clinicaltrials.gov/ct/show/NCT00148798?order=1

Regards, Dew