Theralase Technologies Inc. V.TLT

Anktiva plus BCG Durable CR numbers

[Eoganacht]

Now that Anktiva plus BCG has received FDA approval for the treatment of BCG-unresponsive NMIBC with CIS with or without papillary tumors it is important for Theralase shareholders to go beyond the Internet headlines and be aware of the exact durable complete response numbers that the FDA based their approval on. How does the durable complete response of Ruvidar PDT compare?

It's not easy to find the Anktiva plus BCG results expressed in an easily comparable way but the following link provides the numbers we need to make the comparison:

FDA Approves Bladder Cancer Immunotherapy

Here is the relevant paragraph:

 

"The approval is based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR). The 77 evaluable patients in a single-arm QUILT 3.032 study received Anktiva with BCG maintenance therapy for up to 37 months. The complete response rate was 62% and the duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing. Fifty-eight percent (58%) of patients with complete response had a duration of response ≥ 12 months and 40% had a duration of response at ≥ 24 months."

Approval was based on the 77 patients who have been evaluated at 3 years.

CR at any time was 62% which represents 48 out of 77 patients.

58% of these 48 CR patients had a CR at 12 months.
58% of 48 patients = 28 patients
28 out of 77 patients = 36%
12 month CRR 36%

40% of these 48 patients had a CR at 24 months
40% of 48 patients =  19 patients
19 out of 77 patients = 25%
24 month CRR 25%


Anktiva plus BCG and Ruvidar PDT Durable CRR Comparison

	CRR any time	12 month CRR	24 month CRR
Anktiva plus BCG	62%	36%	25%
Optimized Ruvidar PDT	64%	41%	-

The  durable CRR of the standalone optimized Ruvidar PDT treatment is clearly better than that of the Anktiva plus BCG durable CRR. There is good reason to think that Ruvidar PDT patients will have a much higher CR rate at 12 months than 25%. A quick glance at the latest swimmer's plot shows that all of the Ruvidar patients who were CR at 12 months maintained their CR at 15 months.

Ruvidar PDT is a standalone treatment and achieved it's results after only 2 treatments. Anktiva is a combo treatment with BCG (which is in short supply) and going by the prescription label just released by the FDA, patients might require up to 36 treatments!

Label

• For induction: 400 mcg administered intravesically with BCG once a

week for 6 weeks. A second induction course may be administered if

complete response is not achieved at month 3. (2.1)

 

• For maintenance: 400 mcg administered intravesically with BCG once a

week for 3 weeks at months 4, 7, 10, 13 and 19. For patients with an

ongoing complete response at month 25 and later, additional

maintenance instillations with BCG may be administered once a week

for 3 weeks at months 25, 31, and 37. (2.1) 

[BlueFranky]

Thanks Eoganacht.. another great post, always more compelling that we are currently and increasingly superior to anything approved for this type of cancer  ... Not to mention one and done! I can't wait for the world to wake up to the glaring truth of this.

[Donein25]

thanks for the insightful break down Eoganacht. What I also find interesting is that they got approval with just 77 evaluable patients. That is significant because FDA apparently allowed them to just follow the 77 patients 3 years out.  I would think TLT would be given the same type of consideration for possible AA, at or below 100 patients; meaning no new confirmatory trial;  follow

[Eoganacht]

Hi Donein25 - Even though ImmunityBio has marketing approval it looks like they still have to finish their trial. On page 3 of the FDA Approval Letter the Postmarketing Commitments of ImmunityBio are listed. It doesn't look like the trial will end until 2029. FDA Approval Letter POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS UNDER SECTION 506B  We remind you of

[digitalstone]

Great digging Eoganacht ... thanks for sharing ... top shelf mate !

[Eoganacht]

Hi Donein - Your post is really thought provoking. You suggest that maybe we could get AA in the next year or so and this makes a lot of sense to me. ImmunityBio just got approval based on 77 patients and their trial isn't complete so it looks like a kind of accelerated approval. In our case at the end of March we had 52 patients who had received their 15 month assessments. By the end of the

[Donein25]

agreed. Its a reasonable pathway and timetable. And the new mandates of 2 and 3 year surveillance for TLT seem to be in step with what FDA has told ImmunityBio for their approval. Too bad our share price does not take this into consideration as a likely sequence of events in the relatively near future. (more than a few small biotechs have been scooped up by big pharma a year in advance of AA).