Clinical activity of pembrolizumab in trial patients
| Response . | RT (n = 9) . | CLL (n = 16) . | Total (n = 25) . |
|---|---|---|---|
| CR, no. (%) | 1 (11) | 0 | 1 (4) |
| PR, no. (%) | 2 (22) | 0 | 2 (8) |
| PMR, no. (%) | 1 (11) | 0 | 1 (4) |
| SD, no. (%) | 4 (44) | 5 (31) | 9 (36) |
| PD,* no. (%) | 1 (11) | 8 (50) | 9 (36) |
| Could not be evaluated,† no. (%) | 0 | 3 (19) | 3 (12) |
| ORR, % (95% CI) | 44 (14-79) | 0 (—) | 16 (5-36) |
| Median PFS, mo, (95% CI) | 5.4 (2.8-12.2) | 2.4 (1.2-3.3) | 3.0 (2.1-5.4) |
| Median OS, mo, (95% CI) | 10.7 (4.4-NR) | 11.2 (2.8-NR) | 10.7 (4.4-NR) |
| Response . | RT (n = 9) . | CLL (n = 16) . | Total (n = 25) . |
|---|---|---|---|
| CR, no. (%) | 1 (11) | 0 | 1 (4) |
| PR, no. (%) | 2 (22) | 0 | 2 (8) |
| PMR, no. (%) | 1 (11) | 0 | 1 (4) |
| SD, no. (%) | 4 (44) | 5 (31) | 9 (36) |
| PD,* no. (%) | 1 (11) | 8 (50) | 9 (36) |
| Could not be evaluated,† no. (%) | 0 | 3 (19) | 3 (12) |
| ORR, % (95% CI) | 44 (14-79) | 0 (—) | 16 (5-36) |
| Median PFS, mo, (95% CI) | 5.4 (2.8-12.2) | 2.4 (1.2-3.3) | 3.0 (2.1-5.4) |
| Median OS, mo, (95% CI) | 10.7 (4.4-NR) | 11.2 (2.8-NR) | 10.7 (4.4-NR) |
NR, not reached.
Unfirmed PD (uPD) was included in the category of PD. uPD was defined that patients meet the criteria for PD based on the original PD criteria, but was not confirmed 4 weeks later. This criteria was developed into response criteria due to the unknown nature of potential pseudo-tumor progression/tumor flare reaction documented with immunotherapy (see details in the response criteria section in the supplemental Appendix).
Three patients were not evaluated due to the following reason: 2 early deaths before completion of the first cycle of therapy due to 1 drug-related sepsis and 1 unrelated failure to thrive; 1 lost to follow-up after the first dose of treatment.