Theralase Technologies Inc. V.TLT

Keytruda = $265,000 (17 doses per year)

[ScienceFirst]

Intravesical or Systemic Therapy for Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bladder Cancer?

 

By: Mathieu Roumiguie, MD, Peter C. Black, MD | Posted on: 01 Feb 2022

Excerpts:

The results of single-arm registration trials in patients with BCG-unresponsive carcinoma in situ (CIS) have been reported or published for 5 different agents (summarized in the table), including 2 systemic immunotherapies (pembrolizumab and atezolizumab) and 3 intravesical therapies (nadofaragene firadenovec, oportuzumab monatox, and N-803 plus BCG).2–6 Pembrolizumab has been approved by the FDA and is now only the second drug after valrubicin to be approved in this disease state. Oportuzumab monatox was declined approval by the FDA in August 2021 pending additional data and analyses, and nadofaragene is currently under review. Parallel to these rigorous trials, we have observed an increased popularity of sequential gemcitabine/docetaxel in North America, which has arguably become the de facto standard of care in these patients based on multicenter retrospective evidence.7,8

Nadofaragene = $313,000 (4 doses for first year; up to 16 doses over 4 years)
Oportuzumab = $310,000 (36 doses in first year)
Keytruda = $265,000 (17 doses per year)
Gemcitabine + Docetaxel = $172,000 (6 doses total)

[DJDawg]

Hi I may be wrong but there is also the maint protocol for the last one so more likely to be 16-20 doses total. Nadofaragene = $313,000 (4 doses for first year; up to 16 doses over 4 years) Oportuzumab = $310,000 (36 doses in first year) Keytruda = $265,000 (17 doses per year) Gemcitabine + Docetaxel = $172,000 (6 doses total)  - then monthly x 10 to 24 months depending on response.

[CancerSlayer]

  Thanks Dawg...no matter how you look at it, the current & future competition will entail a lot of doses at significant costs, both fiscal & treatment-burden wise.  Cost & dosing factors will continue to play a big role in terms of ultimate commercial viability.  Considering the above factors would have a net negative impact on viability, your efficacy rates better

[Rumpl3StiltSkin]

I wonder if someone like Roswell Park might just pony up a cool $1B since they are aware of our tech? I think there will be a bidding war amongst the Pharmas. Yet, what if they don't care about PDT?

[ScienceFirst]

Rump ... Roswell Park is not a pharma.  Simply an hospital like Princess Margaret Cancer Center, McGill University Health Center, etc ... We will get a suitor as our costs will be lower, the burden on the healthcare will be lower, the toxicity on patients will be lower.  So there will be pressure on big pharmas to lower costs, etc ... by public health care systems, private clinics, etc

[Rumpl3StiltSkin]

So Roswell doesn't have that kind of money? Probably for the best as Pharmas will have much deeper pockets for sure...

[CancerSlayer]

Correction:  Valrubicin 12 month CR = 13% (not 18%)

[N0taP00p]

Slayer, what are your thoughts on the smaller sample size with Theralase? Obviously, the FDA gave the green light for phase 1b completion with a very small sample size and then said 20-25 with similar efficacy and safety is good enough for BTD. These other ones you referenced above had higher sample sizes, correct?  Thoughts appreciated. 

[CancerSlayer]

  Re: sample sizes required for BTD, I don't think our 20-25 patient threshold is an unusually low number, especially when you consider it involves a highly unmet indication.  Re: other referenced drugs, I have not followed the precise patient numbers that were required for a given accelerated pathway....perhaps others can chime in on this.  But historically, investigational

[N0taP00p]

Thank you, Slayer. So even though there are three other drugs out there for this unmet need, as long as the efficacy and safety are good and the duration is equal or better, the total numbers may not matter. Plus add in the convenience and cost factor.  Everything seems to align.  Two more weeks (out of 500 weeks of holding) will require extra patience. 

[Rumpl3StiltSkin]

I think that it might be more that 2 weeks poop. hope I'm wrong. But yeah, TLT's ACT could almost match the clinic lab % numbers in some cancer indications. NOT NMIBC, because the inexact delivery, the fragility and age of the patients, etc. Yet down the road I see no reason why better dosimetry, delivery, techniques, could be developed that would let Ruvidar shine. That won't help SP

[N0taP00p]

Rumpl3... I hope you're wrong too, about the more than two weeks.  They have an obligation to publish the Q4 report.  We will know if they're waiting for an FDA decision or did not submit the data at all.  And we'll hear about the money situation.  Ideally, I want what Eoganacht guessed ie. announce their BTD just before the conference starts. So by April 28th. 

[N0taP00p]

Maybe TLT should identify as a immuno-something company.  That might do the trick. 

[Rumpl3StiltSkin]

Oh, right,  I thought you meant BTD... Lol. Yes that report should be out and be Very Very inter-estink!

[riverrrow]

Don't forget in the Nov 29, 2022 news release TLT's Ruvidar had a 12 month CR of 29% and a 450 day CR of 28%.  

[DeathXray33]

What we have is superior to KILLTRUDA... Not using TLD would be immoral... Why wouldn't they approve? I want Roger to come back soon...

[ScienceFirst]

Not impressive ... on any fronts  Gemcitabine + Docetaxel = $172,000 (6 doses total) Intravesical gemcitabine/docetaxel for NMIBC appears safe and efficacious April 7, 2023 The efficacy and tolerability of Gem/Doce in this cohort study appear to be at least comparable, if not superior, to BCG. The BCG supply-and-demand equation is not likely be solved in the foreseeable future. Yet