RE:RE:RE:Non optimized vs optimized Thanks enrique and Eogan. Also mentioned in corp presentation was that to date there are 3 treated in the US. That seems low and I would expect the rate to pick up in the US given the type of clinical sites chosen in US. Let's hope that the optimized treatment protocol is executed consistently at all US sites.
Eoganacht wrote: Great analysis. Currently 75% CR at 90 days for the optimized patients. And there is still the possibilty of a maximum 86% CR rate at 90 days for the current optimized patients. Exactly the sort of results many expected when the phase 2 trial started. And this is just the beginning. There are another 76 patients coming who will receive 2 optimized treatments who will bring up the overall CR rate at 360 days. The results of the trial could turn out to be spectacularly better than the recently approved Keytruda's 19% 360 day CR.
enriquesuave wrote: To be more thorough, to date 27 patients have been treated at a therapeutic dose ( high dose of drug). Of those 13 have had a non-optimized treatment procedure (patient #4 from PH1 and 1st 12 treated patients from PH2. The remaining 14 patients in total have received an Optimized Treatment Procedure ( patients # 5 & 6 fro PH1 and patients #13-24 from PH2).
Non-optimized Treatment Arm of 13 ( undertreated by 39-85%): at 90 days post treatment 3 are CR and 2 are PR partial response and remaining 8 NR or no response ( unchanged CIS), but no progression . 23% CR
Optimized Treatment Arm of 14 patients: 6 pending data ( recently treated not yet 90 days), thus 8 with data showing 6 CR or complete response and 1 PR and 1 NR. ( NR patient sadly died of unrelated issue and was counted as a non responder even though his urine cytology test was negative showing no presence of cancer at 30 days with a negative predictive value of about 95% IMO it is very likely that patient was CR, but cannot be counted as such). So 75% CR at a minimum so far. Hoping pending 6 patients will fare as well to confirm strong efficacy.
Also great to see that both Optimized treated patients fro PH1 were still CR at 2 years mark after 1 single treatment instillation. All IMO GLTA.
enriquesuave wrote:
1st 12 patients undertreated by 39-85% yielded a 25% CR or 3 patients at 90 days
6 optimized treated patients yielded 67% or 4 out of 6 patients and maybe would have been 5 as one patient died after negative urinate cytology.
Hence Optimized is about 2-4 Times as likely to get CR at 90 days. IMO