QUILT-3.032 Trial - BCG & N-803 for BCG-Unresponsive NMIBCWe learned last month that the FDA has accepted the resubmission of a biologics license application (BLA) for N-803 (Anktiva) in combination with BCG as a treatment for BCG-unresponsive, NMIBC in-situ.
https://www.cancernetwork.com/view/fda-accepts-resubmitted-bla-for-n-803-plus-bcg-in-nmibc The durable CR results for this trial are as follows:
| Endpoint | CIS Cohort |
| Complete Response at any time | 58 (71%) of 82 patients |
| Duration of Response | |
| Duration = 3 months | 45 (55%) |
| Duration = 6 months | 46 (56%) |
| Duration = 12 months | 37 (45%) |
| Duration = 18 months | 27 (33%) |
But this treatment is dependent on BCG (which is in short supply), and to attain these results, patients must endure 18 treatments. Once the treatments stop it remains to be seen how long the CR will endure. The CR rate drops12% between 12 and 18 months. Not coincidentally, the last treatment is at the end of 13 months. Here is the treatment description.
"All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (induction). Patients without disease progression at Months 3, 6, 9 and 12 are eligible for continued BCG + ALT-803 treatment (maintenance). The study duration is 24 months." Here is a list of the treatments:
Induction Treatments
Study Day 1 (start of Week 1)
Study Day 8 (start of Week 2)
Study Day 15 (start of Week 3)
Study Day 22 (start of Week 4)
Study Day 29 (start of Week 5)
Study Day 36 (start of Week 6)
Maintenance Treatments
Month 4 (~Week 13-14*):
Month 4 (~Week 14-15):
Month 4 (~Week 15-16):
Month 7 (~Week 28)
Month 7 (~Week 29)
Month 7 (~Week 30)
Month 10 (~Week 41)
Month 10 (~Week 42)
Month 10 (~Week 43)
Month 13 (~Week 53)
Month 13 (~Week 54)
Month 13 (~Week 55)