Summary of tumor response, duration of response, PFS rate, and OS rate in patients with rrCLL, rrDLBCL, and rrMM who received pembrolizumab plus dinaciclib
| Efficacy assessment . | Pembrolizumab + dinaciclib, N = 72 . | ||
|---|---|---|---|
| rrCLL, n = 17 . | rrDLBCL, n = 38 . | rrMM, n = 17 . | |
| Objective response | 5 (29.4) | 8 (21.1) | 0 (0.0) |
| CR | 0 (0.0) | 4 (10.5) | 0 (0.0) |
| PR | 5 (29.4) | 4 (10.5) | 0 (0.0) |
| Stable disease | 3 (17.6)* | 3 (7.9) | 8 (47.1)† |
| PD | 6 (35.3) | 16 (42.1) | 8 (47.1) |
| Disease control rate‡ | 8 (47.1) | 11 (28.9) | 8 (47.1) |
| Not evaluable | 0 (0.0)§ | 11 (28.9) | 1 (5.9)§ |
| Efficacy assessment | 3 (17.6) | 0 (0.0) | 0 (0.0) |
| Median DOR, months (range)ǁ | 10.3 (2.7+ to 11.1) | 4.9 (2.1 to 23.7+) | 0.0 (0.0-0.0) |
| Median PFS, months (range)ǁ | 5.2 (1.4-12.4) | 2.1 (1.8-2.6) | 1.6 (0.7-2.8) |
| 3-mo rate (%) | 50.0 (24.5-71.0) | 31.6 (17.7-46.4) | 23.5 (7.3-44.9) |
| 6-mo rate (%) | 50.0 (24.5-71.0) | 13.2 (4.8-25.8) | 17.6 (4.3-38.3) |
| 12-mo rate (%) | 25.7 (6.9-50.1) | 7.9 (2.0-19.1) | 5.9 (0.4-23.5) |
| Median OS, months (range)ǁ | 21.7 (9.5-NR) | 7.9 (3.2-14.0) | 10.5 (2.6-13.5) |
| 3-mo rate (%) | 88.2 (60.6-96.9) | 68.4 (51.1-80.7) | 70.6 (43.1-86.6) |
| 6-mo rate (%) | 82.4 (54.7-93.9) | 57.9 (40.8-71.7) | 64.7 (37.7-82.3) |
| 12-mo rate (%) | 63.3 (35.8-81.6) | 39.5 (24.2-54.4) | 41.2 (18.6-62.6) |
| Efficacy assessment . | Pembrolizumab + dinaciclib, N = 72 . | ||
|---|---|---|---|
| rrCLL, n = 17 . | rrDLBCL, n = 38 . | rrMM, n = 17 . | |
| Objective response | 5 (29.4) | 8 (21.1) | 0 (0.0) |
| CR | 0 (0.0) | 4 (10.5) | 0 (0.0) |
| PR | 5 (29.4) | 4 (10.5) | 0 (0.0) |
| Stable disease | 3 (17.6)* | 3 (7.9) | 8 (47.1)† |
| PD | 6 (35.3) | 16 (42.1) | 8 (47.1) |
| Disease control rate‡ | 8 (47.1) | 11 (28.9) | 8 (47.1) |
| Not evaluable | 0 (0.0)§ | 11 (28.9) | 1 (5.9)§ |
| Efficacy assessment | 3 (17.6) | 0 (0.0) | 0 (0.0) |
| Median DOR, months (range)ǁ | 10.3 (2.7+ to 11.1) | 4.9 (2.1 to 23.7+) | 0.0 (0.0-0.0) |
| Median PFS, months (range)ǁ | 5.2 (1.4-12.4) | 2.1 (1.8-2.6) | 1.6 (0.7-2.8) |
| 3-mo rate (%) | 50.0 (24.5-71.0) | 31.6 (17.7-46.4) | 23.5 (7.3-44.9) |
| 6-mo rate (%) | 50.0 (24.5-71.0) | 13.2 (4.8-25.8) | 17.6 (4.3-38.3) |
| 12-mo rate (%) | 25.7 (6.9-50.1) | 7.9 (2.0-19.1) | 5.9 (0.4-23.5) |
| Median OS, months (range)ǁ | 21.7 (9.5-NR) | 7.9 (3.2-14.0) | 10.5 (2.6-13.5) |
| 3-mo rate (%) | 88.2 (60.6-96.9) | 68.4 (51.1-80.7) | 70.6 (43.1-86.6) |
| 6-mo rate (%) | 82.4 (54.7-93.9) | 57.9 (40.8-71.7) | 64.7 (37.7-82.3) |
| 12-mo rate (%) | 63.3 (35.8-81.6) | 39.5 (24.2-54.4) | 41.2 (18.6-62.6) |
Data are n (%) unless otherwise specified. Tumor response as assessed by investigator review per International Workshop on CLL guidelines (2008) for the rrCLL cohort, International Myeloma Working Group Uniform Response Criteria (2006) for the rrMM cohort, and revised International Working Group response criteria for malignant lymphoma (2007) for the rrDLBCL cohort. 95% CIs are based on the Clopper-Pearson CI method.
NR, not reached.
Includes 1 patient with stable disease per investigator; however, the response was considered PD per International Workshop on CLL 2008 criteria.
Includes 1 patient with stable disease per investigator who did not have measurable disease at baseline.
Includes stable disease, partial responses, and complete responses for patients in the rrCLL and rrDLBCL cohorts; includes stable disease, partial responses, very good partial responses, stringent complete responses, and complete responses for patients in the rrMM cohort.
Patients received only 1 cycle.
From product-limit (Kaplan-Meier) method for censored data.