RE:RE:RE:One more look at the new 90 day optimized data Yep...& at the time that 30% FDA benchmark was made, it was a fairly subjective decision agreed upon by just a few experts. Practically speaking, our single-agent competition (Keytruda) recently set our new benchmarks imho....41% CR, 19% CR at 12 months, & 11% still responding at 24 months. The median duration of response (mDOR) was ~16 months.
The mDOR is defined as the length of time a cancer continues to respond to treatment without the cancer growing or spreading. Those patients who are NRs at 90 days but show no cancer progression (i.e. unchanged CIS disease) are not only eligible for a 2nd treatment & can potentially become a CR over time, these patients would positively impact the mDOR as long as they remain w/o disease progression...that is my understanding. This is another important benchmark the FDA will look at & this company's ACT has the potential to uniquely outperform imo...in the cases it cannot completely destroy the cancer in one or two fell swoops, it can perhaps keep an aggressive cancer at bay for a longer period utilizing its unique immune-stimulating properties. All imo. GLTA.
Eoganacht wrote: Great analysis. 54% CR at 450 days is 24% higher than the FDA benchmark of 30% CR at 18 to 24 months which, according to ImmunityBio, was deemed "likely too high and may not be realistically achievable".
https://immunitybio.com/immunitybio-announces-over-24-months-median-duration-of-complete-remission-with-100-nmibc-cis-patient-survival-setting-a-new-magnitude-of-benefit-in-patients-with-bcg-unresponsive/
enriquesuave wrote: An analysis of NR patients in overall data on all 38 patients, we have
3 patients from PH1: 2 CR post 450 days ( who received an Optimized Treatment) and 1 NR ( non optimized treatment)who probably had metastatic disease prior to treatment undiagnosed. That 1 NR patient should have probably not been included in trial or data.
1st set of 12 PH2 patients who were undertreated by 39-85% of which 5 were wrongly dropped ( due error in trial criteria ) Only 7 were eligible after error to receive a second treatment, of which 4 got a second Optimized treatment. So 5 patients counted as NR should really be excluded in all fairness as they got severely undertreated and never received a second treatment whatsoever, but are counted as NR.
23 patients received an Optimized Treatment from the start. ( Optimizations can improve over time as learning curve progresses IMO). 1 patient who passed away from unrelated issue is counted as NR.
Normally should be treated as a patient who dropped out of trial, and not counted at all. All IMHO
So overall we have 7 patients who are counted as NR, but should normally not be counted at all So if they were not counted, data would be recalculated out of 31 patients. Just to give an example, our numbers at 450 days would look like 5 out of 13 patients would be CR Vs 5 out of 20. That would equate to 38.5% CR on evaluable patients vs 25%, plus 2 PR patients out of these same 13 for a potential CR of 54% at 450 days. All IMO of course . So with mistakes out of the way and Optimized Treatment improvements, we shall hopefully get to those kind of numbers over time. To be noted that the FDA will be made aware of all of these important details in their analysis of the data. All IMHO do your own DD I have done mine. GLTA
Eoganacht wrote: I changed the percentages to patient counts for the recent 90 day numbers for the:
23 patients enrolled and treated in Study II who received an optimized primary study treatment
CR = 12
PR = 4
Pending = 3
NR = 4
Potential CR = 82%
In the last newsletter there were 18 post-Aug 20 2020 optimized patients
CR = 8
PR = 2
Pending = 7
NR = 1
Potential CR = 94.4%
In the period between the two news releases 7 patients reached 90 days and 5 more patients were treated for a total of 12 patients. Of these 12 patients there were:
CR = 4
PR = 2
Pending = 3
NR = 3
Potential CR = 75%
Out of these 12 patients 3 patients (25%) were NR. The results of just these 3 patients accounts for the drop in 90 day potential CR. We will probably never know what happened with these 3 probably very sick and elderly patients but given where we are in the trial it will likely have little overall effect. If you flip a coin 12 times you won't likely get 6 heads and 6 tails. You might get 4 tails and 8 heads. But if you fip a coin 100 times it will be much closer to 50% heads and 50% tails. If those 3 patients had been CR or PR we would have a 90 day potential CR of 96% and the sp would have reached new heights IMHO. But this isn't the first time Theralase's sp has taken an unexpected and unwarranted hit.