Analysis of DOR by the investigator
| . | Cohort 1 ENKTL (N = 22) . | Cohort 2a PTCL-NOS (n = 21) . | Cohort 2b AITL (n = 11) . | Cohort 2c ALCL (n = 12) . | Cohort 2 Total (N = 44) . | Cohort 3 MF or SS (N = 11) . |
|---|---|---|---|---|---|---|
| Number of responders, n (%) | 7 (31.8) | 5 (23.8) | 2 (18.2) | 2 (16.7) | 9 (20.5) | 5 (45.5) |
| Median follow-up, mo (95% CI)∗ | 12.5 (8.3-13.9) | 20.9 (9.1-20.9) | NE (NE-NE) | NE (NE-NE) | 20.9 (9.1-20.9) | 9.8 (2.8-NE) |
| Median DOR, mo (95% CI)† | NE (2.7-NE) | NE (2.7-NE) | 2.9 (2.5-3.2) | 8.3 (8.2-8.4) | 8.2 (2.5-NE) | 11.3 (2.8-11.3) |
| Event-free rate, % (95% CI)‡ | ||||||
| At 3 mo | 85.7 (33.4-97.9) | 80.0 (20.4-96.9) | 50.0 (0.6-91.0) | 100.0 (NE-NE) | 77.8 (36.5-93.9) | 53.3 (6.8-86.3) |
| At 6 mo | 71.4 (25.8-92.0) | 80.0 (20.4-96.9) | 0.0 (NE-NE) | 100.0 (NE-NE) | 66.7 (28.2-87.8) | 53.3 (6.8-86.3) |
| At 9 mo | 57.1 (17.2-83.7) | 60.0 (12.6-88.2) | 0.0 (NE-NE) | 0.0 (NE-NE) | 33.3 (7.8-62.3) | 53.3 (6.8-86.3) |
| At 12 mo | 57.1 (17.2-83.7) | 60.0 (12.6-88.2) | 0.0 (NE-NE) | 0.0 (NE-NE) | 33.3 (7.8-62.3) | 0.0 (NE-NE) |
| At 18 mo | NE (NE-NE) | 60.0 (12.6-88.2) | 0.0 (NE-NE) | 0.0 (NE-NE) | 33.3 (7.8-62.3) | 0.0 (NE-NE) |
| . | Cohort 1 ENKTL (N = 22) . | Cohort 2a PTCL-NOS (n = 21) . | Cohort 2b AITL (n = 11) . | Cohort 2c ALCL (n = 12) . | Cohort 2 Total (N = 44) . | Cohort 3 MF or SS (N = 11) . |
|---|---|---|---|---|---|---|
| Number of responders, n (%) | 7 (31.8) | 5 (23.8) | 2 (18.2) | 2 (16.7) | 9 (20.5) | 5 (45.5) |
| Median follow-up, mo (95% CI)∗ | 12.5 (8.3-13.9) | 20.9 (9.1-20.9) | NE (NE-NE) | NE (NE-NE) | 20.9 (9.1-20.9) | 9.8 (2.8-NE) |
| Median DOR, mo (95% CI)† | NE (2.7-NE) | NE (2.7-NE) | 2.9 (2.5-3.2) | 8.3 (8.2-8.4) | 8.2 (2.5-NE) | 11.3 (2.8-11.3) |
| Event-free rate, % (95% CI)‡ | ||||||
| At 3 mo | 85.7 (33.4-97.9) | 80.0 (20.4-96.9) | 50.0 (0.6-91.0) | 100.0 (NE-NE) | 77.8 (36.5-93.9) | 53.3 (6.8-86.3) |
| At 6 mo | 71.4 (25.8-92.0) | 80.0 (20.4-96.9) | 0.0 (NE-NE) | 100.0 (NE-NE) | 66.7 (28.2-87.8) | 53.3 (6.8-86.3) |
| At 9 mo | 57.1 (17.2-83.7) | 60.0 (12.6-88.2) | 0.0 (NE-NE) | 0.0 (NE-NE) | 33.3 (7.8-62.3) | 53.3 (6.8-86.3) |
| At 12 mo | 57.1 (17.2-83.7) | 60.0 (12.6-88.2) | 0.0 (NE-NE) | 0.0 (NE-NE) | 33.3 (7.8-62.3) | 0.0 (NE-NE) |
| At 18 mo | NE (NE-NE) | 60.0 (12.6-88.2) | 0.0 (NE-NE) | 0.0 (NE-NE) | 33.3 (7.8-62.3) | 0.0 (NE-NE) |
Only responders are included in the analysis. Percentages are based on patients with BOR of at least PR, except for number of responders.
PD, progressive disease.
Median follow-up was estimated using the reverse Kaplan-Meier method.
DOR for responders (CR or PR) was defined as the time from the date of the earliest qualifying response (PR or better) to the date of PD or death for any cause, whichever occurred earlier. Medians were estimated with the Kaplan-Meier method and 95% CIs were estimated using the method of Brookmeyer and Crowley.
Event-free rates were estimated with the Kaplan-Meier method and 95% CIs were estimated using Greenwood’s formula.