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 these
10 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