Table 3.
Patient characteristics and outcome
|
Response Assessment |
Follow Up |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Subject Number | Stage | Month 3 (Week 12) | Month 6 (Week 24) | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Month 24 |
| 1 | T1 | NR | NR | NR | NR | NR | NR | NR | NR |
| 2 | Ta | NR | NR | NR | NR | NR | ND | NR | NR |
| 3 | T1 | NR | NR | NR | NR | NR | NR | NR | NR |
| 4 | T1 | IC | NR | NR | NR | NR | ND | NR | NR |
| 5 | CIS | No CR | IC | IC | CR | CR | CR | CR | CR |
| 6 | T1 | NR | NR | NR | NR | NR | NR | NR | NR |
| 7 | T1 | NR | NR | NR | NR | NR | NR | NR | NR |
| 8* | CIS | CR | CR | CR | CR | CR | CR | CR | IC |
| 9 | Ta | NR | NR | NR | NR | NR | NR | NR | NR |
CR = complete response; NR = no recurrence; no CR = no complete response; IC = inconclusive; ND = not done
*, only subject to develop a recurrence. Noted at 38 months (CIS), which was treated off study with re-induction with N-803 and BCG, followed by maintenance BCG. After another 28 months of follow-up, subject is disease-free with an intact bladder.