Table 1.
Response at Week 25
| All Patients | TE (n = 6) | TEO (n = 30) |
|---|---|---|
| Rate of CR at week 25 | 0 | 2 (6.7%) |
| 90% CIa | 0–39.3% | 1.2%–19.5% |
| Overall response rate at week 25b | 6 (100%) | 27 (90.0%) |
| 90% CIa | 60.7%–100% | 76.1%–97.2% |
| Response at week 25 | ||
| CR | 0 | 1 (3.3%) |
| CRi | 0 | 1 (3.3%) |
| PR | 5 (83.3%) | 25 (83.3%) |
| PRL | 1 (16.7%) | 0 |
| Nonresponse/missingc | 0 | 3 (10.0%) |
| uMRD < 10−4 CLL cells at week 25 | ||
| Bone marrow | 0 | 1 (3.3%) |
| Bone marrow (with CR/CRi) | 0 | 1 (3.3%) |
| Peripheral blood | 0 | 3 (10.0%) |
| Peripheral blood (with CR/CRi) | 0 | 1 (3.3%) |
| del17p/mutTP53 | TE (n = 1) | TEO (n = 7) |
| Overall response rate at week 25b | 1 (100%) | 6 (85.7%) |
| 90% CIa | 5.0%–100% | 47.9%–99.3% |
| Response at week 25 | ||
| CRi | 0 | 1 (14.3%) |
| PR | 1 (100%) | 5 (71.4%) |
| Nonresponse/missingc | 0 | 1 (14.3%) |
| uMRD < 10−4 CLL cells at week 25 | ||
| Bone marrow | 0 | 0 |
| Peripheral blood | 0 | 2 (28.6%) |
| IgHV unmutated | TE (n = 5) | TEO (n = 27) |
| Overall response rate at week 25b | 5 (100%) | 24 (88.9%) |
| 90% CIa | 54.9%–100% | 73.7%–96.9% |
| Response at week 25 | ||
| CR | 0 | 1 (3.7%) |
| PR | 4 (80.0%) | 23 (85.2%) |
| PRL | 1 (20.0%) | 0 |
| Nonresponse/missingc | 0 | 3 (11.1%) |
| uMRD < 10−4 CLL cells at week 25 | ||
| Bone marrow | 0 | 1 (3.7%) |
| Peripheral blood | 0 | 2 (7.4%) |
Data shown as n (%) unless otherwise indicated.
aTwo-sided CI based on Clopper-Pearson method.
bOverall response rate based on sum of pts who achieved CR, CRi, PR, PRL, and nPR throughout the entire study duration.
cStable disease, progressive disease, nonevaluable, or missing data.
CI = confidence interval; CLL = chronic lymphocytic leukemia; CR = complete response; CRi = complete response with incomplete recovery of bone marrow; IgHV = immunoglobulin heavy chain gene; MRD = minimal residual disease; nPR = nodular partial response; PR = partial response; PRL = partial response with lymphocytosis; pts = patients; TE = combination of tirabrutinib and entospletinib; TEO = triple combination therapy of tirabrutinib, entospletinib, and obinutuzumab; uMRD = undetectable MRD.