Saturday, September 21, 2019 8:31:04 PM
but on Q2 CC, he was more than neutral. From my reading of his comments on Q2
CC, the underline message is very bullish for first look stop, I have
never heard a company provide interim look stop conditioning on HR,
always on a P value like less than 0.01 or 0.001, HR and P value are
related, but not like what He says. Now we know the first look stop for
efficacy P is less than 0.02. For example, We may have HR 0.66, but
the P value may be 0.01, in this case, OPTIMA may stop for efficacy,
this means 99% the HR 0.66 is real compare to the OPTIMA design of HR
0.75, median OS advantage 33% and 80% power at 197 events.
Here is example of interim stop HR and P value with trial assumptions:
Median overall survival was 35.3 months (95% CI, 32.2-NR) for patients receiving XTANDI + LHRH therapy* vs 31.3 months (95% CI, 28.8-34.2) for those receiving placebo + LHRH therapy* (HR = 0.77 [95% CI, 0.67-0.88])
At a prespecified interim analysis for overall survival, XTANDI significantly reduced the risk of death by 29% in patients who received XTANDI + LHRH therapy* vs placebo + LHRH therapy* (HR = 0.71 [95% CI, 0.60-0.84]; P < 0.0001)
https://www.xtandihcp.com/mcrpc-results/primary-endpoints-prevail-trial
The PREVAIL trial was stopped for efficacy on the interim look with above data, OS advantage of 4 months, 35.3 vs 31.3 months, and HR 0.71
risk of death by 29% , but P value less than 0.0001.
By the way, yesterday, Slingshot Insights had a Expert Interview,
we may have someone talking about what the expert DR thinking on
the OPTIMA results next week after the listeners finishing their
positions, IMO. I am expecting very bullish talk from the DR:
https://slingshotinsights.com/projects/1114#
Bewarned: all my uneducated guess on OPTIMA first look stop chances!!!
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