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Re: iwfal post# 158608

Saturday, 06/01/2013 4:43:05 PM

Saturday, June 01, 2013 4:43:05 PM

Post# of 257484
AMGN’s T-Vec had HR=0.79 for OS compared to GM-CSF control arm (a secondary endpoint) in interim analysis of phase-3 trial in advanced melamona, which barely missed being statsig (95% CI: [0.61-1.02]):

http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1826044

As previously reported (#msg-85919597), this trial met its primary endpoint of durable (6mo) response rate with a 16% vs 2% advantage in the T-Vec arm relative to the control arm (p<0.0001).

As the data mature, the OS secondary endpoint could well become statsig.

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