Table 3.
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) |
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.