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Msg  53058 of 53279  at  12/4/2021 2:05:17 PM  by

Bibliobiftek

The following message was updated on 12/5/2021 12:34:05 AM.

 In response to msg 53055 by  Biotechbeagle
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Re: Piper Comments Post Soryaya Results

It will be interesting to see how much DOR was affected by COVID when they release more detailed data. According to the CC, some half of patients in SORAYA who were still on the drug so it could bode well for a PFS/OS end point at the final readout as this will reflect efficacy on non-responders (although it will only be of limited statistical utility without a control arm).
 
Duration of response is defined as

"Duration of response is the time from response (R) to progression/death (P/D)." 
 
 
and from their PR:
 
  • The median DOR is currently 5.9 months (95% CI: 5.6, 7.7). With nearly half of responders continuing on therapy, the duration of response continues to evolve and, with longer follow-up, median DOR could range from 5.7 to just above 7 months.
 
There were about 34 responders out of 106 enrolled. I am not sure how their  current DOR was calculated, for instance it could only reflect the fraction of those 34 who already progressed or died, or it could include those in addition to an estimate based on those who are continuing to respond which should drag up the median estimate given that it's been 6 months since full enrollment.
 
Given that they think the final median will fall within 5.7 to 7 months, I think they may not be including those who are continuing to respond for now and think they will indeed improve the final DOR number.
 


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