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DewDiligence

06/02/13 6:16 PM

#161982 RE: geneman #161978

AMGN—Bottom line is that GM-CSF, by itself, is not even close to an appropriate comparator in 2013.

The trial in question was started in 2009, so I’m not sure what a better comparator would have been at the time.

In a current phase-1/2 trial (http://www.clinicaltrials.gov/ct2/show/NCT01740297 ), AMGN is testing Yervoy ± T-Vec; the primary efficacy endpoint is OS, and results are due in 2016.