Theralase Technologies Inc. V.TLT

2 year CR?

[riverrrow]

Have they accumulated a significant amount of 2 year CR follow up data to release next week?  Will the 2 year CR be 30%.

[DJDawg]

Eog is the best to confirm how many have reached 2 yrs out. On that subject Eog, can you confirm what the best competitor numbers are so far for 2 yr data. What is the percent to beat? I realize that with many of the competitors patients are getting ongoing "maintenance" so any CR data is hard to compare with our 1-2 and done approach.

[Eoganacht]

I know a few competitor numbers: Adstiladrin 24 month CR = 4% N803/Anktiva plus BCG 18 months CR = 33% In 6 months the N803/Anktiva plus BCG 24 month CR rate could drop 12% to 21% I say this because their 45% 12 month CR rate dropped to 33% at 18 months In the 35 patient CORE-001 trial of Cretostimogene plus Keytruda the 24 monthe CR rate was 46% Most of the 35 patienta received 21

[Eoganacht]

in general there is no monotherapy for NMIBC that is remotely competitive with Ruvidar PDT for NMIBCin terms of efficacy and safety. The two competitive NMIBC combination therapies require many more treatments and also have other down sides. N803/Anktiva plus BCG is FDA approved but BCG is in short supply and the BCG variant ImmunityBio intends to use is not approved for use in North America

[O12009]

Great job Eog always very informative. Next week should be the start of what we all have been waiting for.

[CancerSlayer]

Yep...I pay little attention to such comparisons (mono vs combo therapies) as they are truly apples to oranges comparisons.  As you implied, the significance of a particular 24 month DOR with a combo therapy can be misleading as there are few/no combo studies with which you can compare outcomes for a given indication.   Digging deeper into the N803/Anktiva + BCG trial, Cohort C

[DJDawg]

Thanks Eog! Your posts are so informative. I think that oncology does not have too many one and done chemo protocols in general. Many are induction followed by maintenance. As such I think that they have gotten lulled into calling the CR and DOR from the first sign that cancer cannot be found. Not finding it doesn't mean its not there. I think this carried over to NMIBC which is why all these

[CancerSlayer]

Well said... Makes our one or two-and-done option that much more attractive from a treatment burden/side effect standpoint, especially when considering the possibility of adminitering a re-treatment(s) with our tech.   Re: the recent N803 + BCG combo trial, it was interesting to see the number/type of treatments that were needed for this combo therapy to achieve its results.  Of note

[Eoganacht]

As of October 16, 2023, 42 patients had been assessed at 450 days. Those 42 patients should have now received their 2 year assessments. 14 of the 42, or 33% had a CR at 450 days. Given how durable the response is turning out, I don't think it's too much to hope that 30% of patients will be CR at 2 years. The only question is, how much post-450 day data has been sent to Theralase by the

[riverrrow]

Thanks for the data.

[Oilminerdeluxe]

Yes, agree. Thanks, Eoganacht. Numbers are always interesting to digest. With a little luck, we should have an updates to sink our teeth into next week. Have a wonderful weekend everyone.

[StevenBirch]

If we do get that data early next week shouldn't we also expect some movement on BTD to be included in this update? I mean more specific info and not the 'Q3 or early Q4' that we normally get?