Theralase Technologies Inc. V.TLT

RE:As a basis of comparison...

[Rumpl3StiltSkin]

Eoganacht wrote: 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.

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.