Table 1.
Comparison of two studies of immune checkpoint inhibitors in bladder cancer
| Author | Powles et al. [14■■] | Plimack et al. [33■■] |
|---|---|---|
| Phase | I expansion | Ib |
| Medication | MPDL3280A (anti-PD-L1) | Pembrolizumab (anti-PD-1) |
| No. of patients/no. evaluable | 68/67 | 33/29 |
| At least two previous chemotherapies | 48 (72%) | 15 (45%) |
| Stage of disease | 4 | 4 |
| Metastases: liver | 22 | 7 |
| ORR | 17 (2 CR + 15 PR) (25%) | 7 (3 CR + 4 PR) (24%) |
| Ongoing response at last follow-up | 16/17 | 6/7 |
| SD | 21 (31%) | 4 (14%) |
| Biomarker | IHC, PD-L1 | IHC, PD-L1 |
| Median follow-up (months) | 4.2 months (IHC 2/3); 2.7 months (IHC 0/1) | 11 months |
| Drug administration/duration | 15mg/kg IV Q3W, 16 cycles or 1 year | 10 mg/kg IV Q2Wa |
| Total AEs | 39 (57%) | 20 (61%) |
| Grade 3 AEs | 3 (4%) | |
| >Grade 3 AEs | 0 | 4 (12%) |
| Nephrotoxic AEs | 0 | 0 |
| Decrease in size of primary lesion | 33 (49%) | 16 (55%) |
| PFS | 24 weeks (IHC 2/3); 8 weeks (IHC 0/1) | 37 weeks |
| OS (months) | - | 9.3 |
| Males | 48 (71%) | 23 (70%) |
AE, adverse event; CR, complete response; IHC, immunohistochemistry; IV, intravenous; ORR, overall response rate; OS, overall survival; PD-1, programmed death 1; PD-L1, programmed death ligand 1; PFS, progression-free survival; PR, partial response; SD, stable disease.
At the discretion of the investigator, patients who received pembrolizumab for ≥24 weeks and for at least two treatments beyond confirmed complete response may discontinue therapy. Patients who experience progression may be eligible for up to 1 year of additional pembrolizumab if no other anticancer therapy was received. If clinically stable, patients are to remain on pembrolizumab until progressive disease is confirmed on a second scan performed ≥4 weeks later.