Biotech Values

[DewDiligence]

AMGN’s T-Vec misses melanoma final-OS endpoint by a hair:

http://finance.yahoo.com/news/amgen-provides-phase-3-study-130000552.html

In Jun 2013, AMGN reported an interim OS HR of 0.79 (95% CI: [0.61-1.02]), missing the 1.00 cut-off by a whisker (#msg-88540327). The final OS HR, reported in yesterday’s PR above, was essentially unchanged from the interim value (p=0.051).

In Mar 2013, AMGN reported that the 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 (#msg-85919597).

The combination trial of Yervoy ± T-Vec continues; the ctg listing now shows “primary completion” in Dec 2015 (http://www.clinicaltrials.gov/ct2/show/NCT01740297 ), but I’m not sure if that date is for safety or for OS.