Theralase Technologies Inc. V.TLT

FDA to rule on BLA for N-803 + BCG for NMIBC by May 23, 2023

[Eoganacht]

If the FDA rules favourably for ImmunityBio's BLA in May what will this mean for TLD1433 pdt? The following quote about the combination N-803 + BCG trial results is from: https://www.precisionvaccinations.com/vaccines/n-803-plus-bcg-vaccine-therapy

"On December 27, 2022, an editorial from urological cancer experts from Memorial Sloan Kettering Cancer Center stated: "The efficacy and minimal toxicity of this combination represents a major advance for the care of patients with BCG-unresponsive NMIBC, and the authors should be congratulated. In addition, this promising combination offers a potential alternative to cystectomy and may allow us to move beyond single-arm studies toward randomized phase 3 trials against other novel therapies.""

How do the results of our current trials compare? ImmunityBio's Trial has been divided into 3 cohorts - Cohorts A, B and C. The results of Cohorts A and C can be directly compared to our trial, as Cohort A represents CIS with Ta/T1papillary disease and Cohort C represents CIS without Ta/T1 papillary disease. Our trial is for CIS with or without Ta/T1 papillary disease, so our trial is directly comparable to the results of Cohorts A & C taken together.

In Cohort A 37 of 82 evaluable patients, or 45% attained a CR at 12 months
In Cohort A 27 of 82 evaluable patients, or 32% attained a CR at 18 months

Cohort B didn't do so well. Evaluation of these10 patients was discontinued at 6 months as only one patient had attained a CR. But to do a proper comparison with our trial the 10 unresponsive patients should be taken into account.

In the combination of Cohorts A & B 37 of 92 patients, or 40% attained a CR at 12 months.
In the combination of Cohorts A & B 27 of 92 patients, or 29% attained a CR at 18 months.

So far, with 12 undertreated patients out of 26 evaluated Theralase has achieved a 28% CR rate at 12 months. This number should improve dramatically as the trial continues.

Also of note is how quickly the CR rate of N-803 + BCG dropped between 12 and 18 months - a drop of 11%. TLD1433 pdt patients are much more likely to maintain their CR over time.

Also, as many have mentioned, TLD1433 is a standalone treatment, and N-803 is dependent on BCG, which is in short supply. TLD1433 is also extremely safe and only requires 2 treatments. N803/BCG has the same safety issues as BCG and requires 6 treatments.

https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200167

[Eoganacht]

In my last post whenever I write Cohort B I mean Cohort C. Sorry for the mistake.

[CancerSlayer]

  Hi Eoganacht...thanks for your thoughtful comments. My understanding is that both Cohorts A & C represented CIS patients with or without Ta/T1 papillary disease.  Cohort A represented those who received both N-803 + BCG.  Cohort C represented those who received only N-803.  Cohort C was discontinued for futility due to only 1 of 10 patients maintaining a CR at 6

[Eoganacht]

Good post, CancerSlayer.

[enriquesuave]

Combination trial cannot be compared to a single agent.  It's expected to give better results. However, I do believe TLD-1433 will do as well or better. IMHO time will tell.    

[enriquesuave]

This leads one to wonder how much N-803 really works?  Is the BCG finally kicking in? Or is N-803 really helping?  I do believe it works, but to what extent.  The FDA May turn around and ask IBRX to do a randomized control trial to compare BCG Unresponsive CIS with 2 arms, one BCG alone and one BCG+ N803. Ideally that should have been the optimal way to go especially given the fact

[ukrop13]

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