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newman2021

04/08/23 7:17 PM

#583829 RE: meirluc #583828

meirluc, like we told the rest of the world the phenomena called pseudoprogression in immunotherapy, we should propose to abolish mPFS and mOS comparisons in immunotherapy trials because median arrives too fast too soon in immunotherapy trials almost in race with the SOCs. But if we are able to sustain thru running the trial longer like we endured in our DcVaxL phase 3 trial, then tail does the wonders. We should propose to write immunotherapy trial abstracts in terms of the tail; % of patients alive Vs. survival length.
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Lykiri

04/09/23 2:04 PM

#583898 RE: meirluc #583828

Just wondering how much higher than 7.6 months was the mPFS of the 64 crossovers and how much lower was the mPFS of the 29 remaining permanent placebos.


meirluc,

Not much, IMO
There are 81 events (placebo group n=99)
https://investorshub.advfn.com/uimage/uploads/2022/5/11/jjgyh5-10-22-Slide-11.png
I count 33 events beyond 7.6 months from randomization. IMO, there are 48 events between 0 and 7.6 months from randomization. (33 + 48 = 81 events)
In the optimal scenario 33 placebo patients (with recurrence beyond 7.6 months) could cross over, IMO. NOTE: PFS event = an event being either disease progression or death.
That's why i believe that mPFS of the 64 crossovers is also around 7.6 months from randomization.
You say:

29 remaining permanent placebos.


Why 29???
99 - 64 crossed over to DCVax-L on recurrence = 35 patients. (NOTE:1 withdrew and 5 received placebo only of 99 placebo patients)
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847