Theralase Technologies Inc. V.TLT

RE:RE:RE:SO IM MISSING THE GOOD NEWS

[CancerSlayer]

CancerSlayer wrote:

Beano349 wrote: The good news was the new 450 CR tracking of over 40%. 1 treatment, and a CR over 40 over 1 year later. That's a big deal, but we still need approval...

Good news today...

To be clear, a DOR% is different than a CR% at a given point in time.  A DOR% refers to the % of responders who have maintained their response over a given period or "duration" of time.  A CR% reflects the total number of responders out of the total number treated at any given "point" in time.

The 44% 450 day number reported is referring to a DOR % (of the 41 responders, 18 maintained a response for 360 days).  The 450 day CR would be 18 out of a total of 65 patients treated (or ~28% CR at 450 days).  Per the swimmer's plot, there are 18 patients who have passed the 540 day mark, 2 of whom were determined to have recurrent high-grade NMIBC.  The remaining 16 include 5 responders & 11 who have pending data.  

The encouraging news for me is that of the 7 patients who have undergone evaluation (after 540 days), 5 of 7 (71%) continued to show CR at 690+ days, indicating a promising durable response based on this small subset.   There are also 2 patients who are pre-360 day follow-up...one being IR & the other a CR.  

Based on my rudimentary math/extrapolation, if all goes well with the above 11 pending patients, I'd estimate that ~8 of 11 patients would have a good chance of maintaining their CR for at least 24 months.  This would give a total of 13 patients maintaining a 24+ month response out of a total of 65 treated (20% CR), which would actually beat Keytruda's "12" month CR (~19%).  The 2 pre-360 day patients could potentially bump up our 24 month CR to 21-23%.  

Our current data suggest that this company's therapeutic success as a monotherapy will not only exceed all other monotherapies available, but also rival any combined therapy currently under evaluation or recently approved.  All  imo.  Good luck...

Had a couple of minor corrections for an earlier post.....There were 2 patients who had not yet reached the 450 day mark, which changes the denominator to 63 (not 65).

"The 450 day CR would be 18 out of a total of 65 patients treated (or ~28% CR at 450 days)."

Correction:  The 450 day CR would be 18 out of a total of 63 patients treated (or ~29% CR at 450 days).  


"This would give a total of 13 patients maintaining a 24+ month response out of a total of 65 treated (20% CR)..."


Correction:  This would give a total of 13 patients maintaining a 24+ month response out of a total of 63 treated (21% CR)....

Note:  The data analysis has changed since the August 29, 2023 release (the new math).  Per the August 2023 release, there were a total of 36 CRs at that time.  The secondary objective was defined/interpreted as the total CRs present at 450 days per total number of patients treated who were "evaluable" at that time (13/39 = 33% CR).  This percentage represents a CR for that point in time, not a DOR.  Based on the total of 36 CRs, the DOR would have been 13/36, or 36%.

Per the August 12, 2024 release, the secondary objective was defined as a true DOR (18/41 = 44%).  The total CRs at 450 days per total "evaluable" patients treated would be 18/63 (29% CR).  Total patients treated = 65.


August 2023:   CR = 58%
                        450 day CR = 33%
                        450 day DOR (Secondary Objective) = 36%
                               

August 2024:   CR = 63%
                        450 day CR = 29%
                        450 day DOR (Secondary Objective) = 44%

Summary:  Overall, the primary & secondary endpoints (CR & DOR rates), which the FDA primarily bases its decisions on, continue to trend in a positive direction.  When analyzing all available approved therapies, if one considers their treatment efficacy, cost & overall burden on both the healthcare system & patient, our data to date strongly supports a BTD at minimum.  

All imo..