RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:88% demonstrate that CR at 180 days, 69% at 270 days That is the million dollar question. If TLT was able to achieve a 25% CR in a significantly undertreated group (though in a small sample = 12), odds are that at least 1 or 2 additional CR patients would have come from the fully optimized group of 8 imo, which would equate to 450 day CRs of 37.5% (2 + 1 = 3 of 8) & 50% (2 + 2 = 4 of 8), respectively...still great numbers.
It's very reassuring to see that a predominantly undertreated group was still able to achieve such a relatively high durable response. There are still too many patients pending to give any serious narrow-range guesses re: durable response rates; however, based on the limited data we currently have, if the optimized trends uphold, my conservative estimate of a final 450 day CR rate would be anywhere from 25 to 40% for the entire Ph 2 group. All JMO. GLTA.
Eoganacht wrote: Good post CancerSlayer. Here's a question I'm not sure anyone has an answer to. Were any of the 12 undertreated patients CR at 450 days? If not, shouldn't the 5 out 20 CR at 450 patients (25%) really be considered 5 out of 8 CR patients (62.5%) as only 8 of the 20 really had a fair shake at becoming CR?
CancerSlayer wrote: Great news!
What stood out to me the most & the most meaningful info. imo for the first 20 treated (of which 12 were significantly undertreated) is the following:
There was a 25% CR rate at both the 360 & 450 day assessments.
The 25% CR rate represents a "minimum" CR rate considering there are PR patients yet TBD (3 patients at 360 days & 2 patients at 450 days). This minimum 25% CR rate already beats the approved competition (Keytruda at 19% & Valrubicin at 17%) & is in very good standing with the rest (12 month CR for Nadofaragene = 24%, Oportuzumab = 17%, Atezolizumab = 25%, N-803 + BCG = 40%; the latter obviously requires BCG which is in short supply & also requires a minimum of "18" intravesical treatments, which can lead to patient compliance problems). Additionally, maintaining a 25% CR rate (at 360 & 450 days) at this later stage post-treatment could signal a type of minimum (or near-minimum) durable response threshold where the percent likelihood of a patient maintaining a CR after a certain "late" point may be higher compared to earlier assessment stages....JMO. GLTA.
enriquesuave wrote:
Can someone post the chart with the 1st 20 patients? Since 1st 12 were severely undertreated and 5 were wrongly dropped early on ( never got a Maintenance treatment at 180 days)and one patient died of Heart failure from that group, IMO we are looking very good.
Rumpl3StiltSkin wrote: Enrique, I am very encouraged. What would
really get me going is if we start to see some PR after first dose convert to CR after second dose. THAT would be huge! IMO... It would show the market that trying 1433 again is a great idea if it doesn't work the first time.
enriquesuave wrote: Actually numbers were better for evaluable patients at 180 days (50% CR)vs (46% CR)at 90 days. That is 109% (not 88%). They are being conservative. That is why I'm waiting to see numbers at 270 days which could foretell 360 and 450 days on Optimized patients. 270 days is steady at 39% CR meaning no new data in last month. Next update will show what a second treatment can do in Optimized patients who were NR or PR at 180 days. In the new MD& A released today, the 1st 20 patients chart with all assessments completed shows very good numbers and these include the 1st 12 non-Optimized. If BTD is granted, which it definitely should IMO, and we show consistent data or even better, on a few more patients ( all Optimized) , then AA is next. IMHO.
FGPstock wrote:
I think you guys may be reading this statement wrong. 46% were CR after 90 days. then 88% of the 46% were still CR after 180.
Not sure how the PR factors in
For all Evaluable Patients, who achieved a CR at 90 days, 88% demonstrate that CR at 180 days, 69% at 270 days, 50% at 360 days and 56% at 450 days, demonstrating a strong duration of complete response.