Eoganacht wrote: How do the results of our current trial compare?
ImmunityBio's Trial has been divided into 3 cohorts - Cohorts A, B and C.
Only the results of
Cohort A can be compared to our trial, as
Cohort A represents the
N-803/BCG combo treatment of CIS with or without Ta/T1 papillary disease.
Cohort B represents the
N-803/BCG combo treatment of just Ta/T1 papillary disease.
Cohort C represents
N-803 monotherapy for CIS with or without Ta/T1 papillary disease.
Cohort A - N-803/BCG combo treatment for CIS with or without Ta/T1 papillary disease
37 of 82 patients, or 45% CR at 12 months
27 of 82 patients, or 32% CR at 18 months
Cohort B - N-803/BCG combo treatment for high grade Ta/T1 papillary disease
55% DFS (Disease free survival) at 12 months
Cohort C - N-803 mono treatment for CIS with or without Ta/T1 papillary disease
2 of 10 patients, or 20% CR at 3 months
1 OF 10 patients, or 10% CR at 6 months
Discontinued for futility at 6 months
Basically
N-803 by itself for CIS with or without Ta/T1 papillary disease doesn't work very well.
Cohort A combo treatment achieved
45% CR at 12 months -
Ruvidar PDT achieved 36% Cohort A combo treatment achieved
32% CR at 18 months -
Ruvidar PDT achieved 33% at 15 months
It should be noted how quickly the CR rate of
N-803 + BCG dropped between 12 and 18 months - a drop of 11% -
Ruvidar PDT patients are much more likely to maintain their CR over time.
Also,
Ruvidar PDT is a standalone treatment and
N-803 is dependent on
BCG (which is in short supply)
N-803 as a monotherapy doesn't work well at all. If
Ruvidar PDT was part of a combo therapy there's no telling how good the results might be.
Ruvidar PDT is extremely safe and only requires 2 treatments.
N803/BCG has the same safety issues as
BCG and requires 6 treatments.
Finally, the efficacy results of our
Ruvidar PDT trial are constantly improving. It is very likely that our montherapy durable response will be considerably higher than their combo-therapy durable response.
IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer N0taP00p wrote: This was a resubmission of N-803. Action date is April 23rd 2024. Last time, the FDA had rejected this same application. TLTs BTD clock is ticking. I'm hoping for an update on the timeline next month and how the central pathology lab testing requirements plus additional post-450 day will impact this. For those that keep repeating "BTD and JV very soon", might want to prepare new reasons and justifications to refill the echo chambers.