RE:RE:RE:RE:SO IM MISSING THE GOOD NEWSGood post CancerSlayer - the one quibble I would have is with the number of patients currently considered evaluable at 450 days. If you look at the news release from May 30 - (2 1/2 months ago) - the number of patients evaluable at 450 days is 57.
https://stockhouse.com/news/press-releases/2024/05/30/theralase-r-release-s-1q2024-financial-statements If you look at the swimmers plot of the same news release it is clear that in the last 2.5 months only 2 more patients could have been added to the evaluable at 450 days total. So currently I believe there are 59 patients evaluable at 450 days - not 63
That would make the total CRs at 450 days per total "evaluable" patients treated 18/59 (
31% CR) (if you round up!)
Maybe not much difference between
29% CR and
31% CR but every percentage point.seems meaningful at this point.
CancerSlayer wrote: 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..