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]):
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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