RE:RE:RE:RE:QuestionAn interesting 2020 simulation study by (among others) Dr. Marian Wettstein, Dr. Michael Jewett and Dr. Girish Kulkarni set out to determine what efficacy a novel therapy for BCG-unresponsive NMIBC must achieve in order to compete as a treatment with early radical cystectomy.
The study concluded that the CR rates recommended by the FDA for a clinically meaningful outcome of a single-arm phase II trial (40%50% at 6 months and 30% at 1824 months) are too low and a treatment which only achieved this level of efficacy was not competitive with early radical cystectomy.
They recommended increasing the recommended CR rate to 45%-55% at 6 months and 35% at 18-24 months.
Neither Keytruda nor Adstiladrin achieved adequate efficacy levels. TLD1433, on the other hand, has so far achieved 53% at 6 months and 33% at 15 months and these numbers are steadily increasing.
Required efficacy for novel therapies in BCGunresponsive nonmuscle invasive bladder cancer: Do current recommendations really reflect clinically meaningful outcomes? Eoganacht wrote: I suppose "the risk" is that this is still an unapproved treatment and if it proves ineffective and just lengthens the delay before the standard of care treatment - radical cystectomy - the greater the chance that even such radical surgery will not save the patient's life.
jmm1228 wrote: Thank you Skys1.
I have told a number of friends and family members about TLT.
They are invariably told by their advisors that the risk is higher than they are willing to subject them to. I don't believe any of them do much investigative work on their own,
Amen