Theralase Technologies Inc. V.TLT

As a basis of comparison...

[Eoganacht]

In February 2020, the FDA approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy. In the keytruda trial that led to this decision 96 patients received 200 mg of pembrolizumab every 3 weeks for up to 2 years or until their disease progressed at which point they were removed from the trial. 

At 90 days 41.2% (40 patients) had achieved a CR. At one year 48% of the 40 responding patients (19 patients) were still CR. 19.8% of the original 96 patients had experienced a complete response at one year. 

To demonstrate that TLD1433 works as well as Keytruda when they submit their interim data to the FDA, Theralase only needs to report that 5 of the first 25 patients have a CR at 360 days.

A treatment that works as well as Keytruda, has a much better safety profile and only requires one or two treatments, rather than the 17 treatments a year Keytruda requires  looks like a very attractive alternative.

Even slightly better efficacy would make TLD1433 a much better choice than Keytruda.

[Rumpl3StiltSkin]

Also Eoga, Someone pointed out that Keytruda needs to work with chemo to get these results. If true? That makes the TLT case much more compelling for these mostly older patients.

[DJDawg]

On the subject of keytruda...is that it these days? I know vicineum is not looking too promising at the moment. So the current state for BCG unresponsive cases is.... - ketruda (or an investigation trial such as for TLD1433) - cystectomy after that? Just curious if there were any other products vying for the next line therapy?

[Eoganacht]

This article fromUroToday talks about some alternative treatments if BCG fails, but the standard treatment is cystectomy. ESOU 2021: Alternative Treatments for Refractory Bacille Calmette- Guerin (BCG) Non-Muscle-Invasive Bladder Cancer

[Eoganacht]

There's also this article, which is more comprehensive: Non-muscle-invasive bladder cancer: An overview of potential new treatment options Aim This review article summarizes the current clinical practice guidelines around disease definitions and risk stratifications, and the treatment of non-muscle-invasive bladder cancer (NMIBC). Recently completed and ongoing clinical trials of novel

[Gooseybear]

I have a friend who was given Keytuda and had to stop as it was destroying his kidneys. My Urologist told me that the side effects are more harmful than the disease. My friend is scheduled for bladder removal on September 10 so praying for his speedy recovery. My follow up cystoscope is in October after receiving BCG for reoccurring CIS after 3 years Ned.

[gojotv!]

I believe that in the U.S., you have "Right to try". If you and your friends get together with a doctor and make a deal with the company about the cost... I don't know... Just a thought.

[DJDawg]

Interesting points. I recall the SESN made a good point in one of their talks that keytruda often (not always) means that the patient's care transfers to oncology. Many have relationships with the patients over time so transfering care for keytruda treatment is intrinsically less appealing than continuing to manage within scope of practice (i.e. TLD1433 plus lasers). Obviously MD will do what

[skys1]

Gooseybear, Why doesn't your friend try Theralase's ACT through the "right to try" legislation to save his bladder? I do agree with you on Keytruda. My former neighbor's side effects after treatments were so painful he would sit on his sofa and cry. He died shortly thereafter. 

[CAinPlap]

I'm assuming you have told your friend about TLT. Was he/she also not eligible for TLT or not interested?

[Gooseybear]

Based on my knowledge of his medical history and my experience dealing with TLT, he would not have qualified.

[CAinPlap]

It would be interesting to hear how the principal investigators or doctors are explaining the options to bladder cancer patients who are willing to participate in either TLT or Keytruda trials. I may be somewhat biased but if they were doing a good job and were not being influenced by the market cap of the trial sponsor, I cannot see how anyone would opt for the Keytruda route.

[Pandora]

The whole group of CDC, NIH, NIAID, & FDA is now just a hot bed of politics and money trails. Like peas in a pod or fish in a pond -- they're all swimming in the same sauce.

[Gooseybear]

I have reoccurring nmibc cis HGTI and reached out directly to Theralase in an attempt to enroll in their US trial in N C. I was told that I had been NED for too long since my last BCG so I wasn't a candidate.

[wildbird1]

To complement this post by Eoganacht... In "URO TODAY" Dated April 5,2021, by Bishoy M.Faltas, MD, Director of Bladder cancer Research, New York.... Bishoy M.Faltas said " However, pembrolizumab(Keytruda) cost over $100,000 US per year and has a significant rate of adverse effects. The study revealed that pembrolizumab(Keytruda) was not cost-effective relative to RCx(radical