Progression-free survival and response to treatment
| . | Dinaciclib (n = 20) . | Ofatumumab (n = 24) . |
|---|---|---|
| PFS | ||
| PFS events* | 11 (55.0) | 17 (70.8) |
| Person-months | 213 | 135 |
| Event rate/100 person-months, % | 5.2 | 12.6 |
| Median PFS, months (95% CI)† | 13.7 (10.3, 21.2) | 5.9 (2.1, 9.4) |
| Response to treatment‡ | ||
| Complete | 0 (0.0) | 0 (0.0) |
| Partial | 8 (40.0) | 2 (8.3) |
| Overall response | 8 (40.0) | 2 (8.3) |
| Stable disease | 7 (35.0) | 11 (45.8) |
| Progressive disease | 1 (5.0) | 1 (4.2) |
| Not evaluable§ | 4 (20.0) | 10 (41.6) |
| . | Dinaciclib (n = 20) . | Ofatumumab (n = 24) . |
|---|---|---|
| PFS | ||
| PFS events* | 11 (55.0) | 17 (70.8) |
| Person-months | 213 | 135 |
| Event rate/100 person-months, % | 5.2 | 12.6 |
| Median PFS, months (95% CI)† | 13.7 (10.3, 21.2) | 5.9 (2.1, 9.4) |
| Response to treatment‡ | ||
| Complete | 0 (0.0) | 0 (0.0) |
| Partial | 8 (40.0) | 2 (8.3) |
| Overall response | 8 (40.0) | 2 (8.3) |
| Stable disease | 7 (35.0) | 11 (45.8) |
| Progressive disease | 1 (5.0) | 1 (4.2) |
| Not evaluable§ | 4 (20.0) | 10 (41.6) |
Data are presented as n (%) of patients, unless otherwise indicated. Small sample sizes due to early study termination precluded testing of statistical significance.
CI, confidence interval.
PFS is defined as the time from randomization to disease progression or death, whichever occurred first.
From product-limit (Kaplan-Meier) method for censored data.
Patients’ best response to therapy, according to investigator assessment across time points per the 2008 International Workshop on CLL criteria.
Patients were required to have at least 2 postbaseline scans for an evaluable response.