Efficacy results (ORR, DOR, PFS, OS)
| Efficacy . | PTCL (n = 33) . | CTCL (n = 29) . |
|---|---|---|
| ORR,∗ n (%) | 15 (45.5) | 12 (41.4) |
| 80% CI, % | 33.3-58.0 | 28.8-55.0 |
| 95% CI, % | 28.1-63.6 | 23.5-61.1 |
| Best overall response,† n (%) | ||
| CR | 11 (33.3)‡ | 1 (3.4) |
| PR | 4 (12.1)‡ | 11 (37.9) |
| SD | 6 (18.2) | 11 (37.9)§ |
| PD | 10 (30.3) | 1 (3.4) |
| Unable to determine | 2 (6.1) | 5 (17.2) |
| TTR, median (range), mo | 1.4 (1.1-5.5) | NR (0.7-10.1) |
| TTCR, median (range), mo | 2.6 (1.1-7.6) | 4.8 (4.8-4.8) |
| DOR, median (95% CI), mo | 4.6 (2.8-12.8) | 27.0 (2.8-NR) |
| DOCR, median (95% CI), mo | 7.4 (2.2-NR) | NR |
| PFS‖, median (95% CI), mo | 4.3 (1.6-5.6) | 15.6 (4.9-NR) |
| PFS rate at 12 mo, % (95% CI) | 13.8 (2.9-33.0) | 67.6 (43.3-83.3) |
| PFS rate at 24 mo, % (95% CI) | 6.9 (0.5-25.6) | 46.4 (18.3-70.7) |
| OS‖, median (95% CI), mo | 11.1 (5.2-15.3) | 37.2 (18.6-NR) |
| OS rate at 12 mo, % (95% CI) | 45.1 (27.7-61.0) | 78.9 (58.9-89.9) |
| OS rate at 24 mo, % (95% CI) | 25.8 (12.3-41.6) | 62.9 (41.7-78.1) |
| Efficacy . | PTCL (n = 33) . | CTCL (n = 29) . |
|---|---|---|
| ORR,∗ n (%) | 15 (45.5) | 12 (41.4) |
| 80% CI, % | 33.3-58.0 | 28.8-55.0 |
| 95% CI, % | 28.1-63.6 | 23.5-61.1 |
| Best overall response,† n (%) | ||
| CR | 11 (33.3)‡ | 1 (3.4) |
| PR | 4 (12.1)‡ | 11 (37.9) |
| SD | 6 (18.2) | 11 (37.9)§ |
| PD | 10 (30.3) | 1 (3.4) |
| Unable to determine | 2 (6.1) | 5 (17.2) |
| TTR, median (range), mo | 1.4 (1.1-5.5) | NR (0.7-10.1) |
| TTCR, median (range), mo | 2.6 (1.1-7.6) | 4.8 (4.8-4.8) |
| DOR, median (95% CI), mo | 4.6 (2.8-12.8) | 27.0 (2.8-NR) |
| DOCR, median (95% CI), mo | 7.4 (2.2-NR) | NR |
| PFS‖, median (95% CI), mo | 4.3 (1.6-5.6) | 15.6 (4.9-NR) |
| PFS rate at 12 mo, % (95% CI) | 13.8 (2.9-33.0) | 67.6 (43.3-83.3) |
| PFS rate at 24 mo, % (95% CI) | 6.9 (0.5-25.6) | 46.4 (18.3-70.7) |
| OS‖, median (95% CI), mo | 11.1 (5.2-15.3) | 37.2 (18.6-NR) |
| OS rate at 12 mo, % (95% CI) | 45.1 (27.7-61.0) | 78.9 (58.9-89.9) |
| OS rate at 24 mo, % (95% CI) | 25.8 (12.3-41.6) | 62.9 (41.7-78.1) |
DOCR, duration of CR; OS, overall survival; PR, partial response; SD, stable disease; TTCR, time to CR; TTR, time to response.
CIs based on the Clopper-Pearson method.
Based on Lugano Classification 2014.15
There were 3 patients with baseline PD-L1 < 1% in the PTCL cohort; 2 achieved a CR and 1 a PR.
There was 1 patient with baseline PD-L1 < 1% in the CTCL cohort; this patient achieved SD.
Median and rates calculated using Kaplan-Meier method.