Theralase Technologies Inc. V.TLT

RE:N-803 median duration of response

[CancerSlayer]

Eoganacht wrote: ImmunityBio has concluded their Quilt 3.032 trial of N-803 and BCG for BCG-unresponsive NMIBC, presented their final results at ASCO22 and submitted their BLA to the FDA.

This is from the ASCO22 presentation by principal investigator Karim Chamie.

"CIS patients have a CR rate of 71% (59/83), with a median duration of CR of 24.1 months in responders"

Duration of response means the time from the initial response to progression/death. The definition of median is - denoting or relating to a value or quantity lying at the midpoint of a frequency distribution of observed values or quantities, such that there is an equal probability of falling above or below it.

So it seems that 24 months is the point where half of the responders, or 36%, have progressed or died.

This seems to be a very roundabout way of saying that the CR rate at 2 years is 36%

Given results so far I think the TLD1433 trial has a very good chance of equalling or surpassing these numbers.

Final clinical results of pivotal trial of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive CIS and papillary nonmuscle-invasive bladder cancer (NMIBC)

Results:

 

To date, we enrolled 160 patients (83 CIS, 77 Papillary). In the overall population, median age is 72.3 years, 81% male, with mean number of prior TURBT = 4. Median number of prior BCG doses = 12. CIS patients have a CR rate of 71% (59/83), with a mediation duration of CR of 24.1 months in responders; 91% avoided cystectomy and 96% 24 month bladder cancer specific progression free survival (defined as progression to MIBC). Papillary patients have a 57% 12 month DFS rate, 48% 24 month DFS rate, and 95% avoided cystectomy. Median time to cystectomy in responders (N = 4) is 12.9 months versus 7.8 in non-responders (N = 8) for a 5.1 month delay in cystectomy. PK data shows no systemic levels of N-803; activity is confined to the bladder. Low grade treatment related AEs (grade 1-2) include dysuria (22%), pollakiurua (19%), hematuria (18%), fatigue (16%), and urgency (12%), all other AEs were seen at 7% or less. No treatment related grade 4 or 5 AE were seen. No SAE's were considered treatment related. No immune related SAE's have been seen.

 

Thanks for that Eoganacht.  I appreciate the info. & your optimism...however, I do note that with each of our data updates, I find myself having as many questions as answers ; ).

A CR of 36% at 24+ months is an impressive achievement, but scientifically speaking, it's comparing their sour apples to our sweet oranges.  If they were to use N-803 without BCG (without BCG acting like the primary vaccine & N-803 providing the immune boost), I highly doubt they would be able to achieve similar durable response %s.  I also believe that using our ACT (with its efficient cell kill & immune boosting capabilities) + BCG, we would more than likely be able to achieve at least similar numbers, & likely higher imo....and perhaps be able to do it with fewer BCG doses?   Lots of variant protocols/trials awaiting our ACT.  Some Pharmas are likely biting at the bit...