Investigator-assessed CR/CRi as a predictor of investigator-assessed PFS
| Treatment group PFS event . | PFS event rate . | HR (95% CI)∗ . | P value∗ . | |
|---|---|---|---|---|
| CLL with CR/CRi . | CLL without CR/CRi . | |||
| A + O | n = 66 | n = 113 | ||
| Death | 3 (4.5) | 19 (16.8) | 0.29 (0.13-0.65) | .0026 |
| Disease progression | 4 (6.1) | 15 (13.3) | ||
| Death or disease progression | 7 (10.6) | 34 (30.1) | ||
| A | n = 34 | n = 145 | ||
| Death | 2 (5.9) | 26 (17.9) | 0.20 (0.07-0.55) | .0017 |
| Disease progression | 2 (5.9) | 34 (23.4) | ||
| Death or disease progression | 4 (11.8) | 60 (41.4) | ||
| A ± O | n = 100 | n = 258 | ||
| Death | 5 (5.0) | 45 (17.4) | 0.23 (0.12-0.42) | <.0001 |
| Disease progression | 6 (6.0) | 49 (19.0) | ||
| Death or disease progression | 11 (11.0) | 94 (36.4) | ||
| O + Clb | n = 24 | n = 153 | ||
| Death | 2 (8.3) | 11 (7.2) | 0.34 (0.19-0.62) | .0004 |
| Disease progression | 10 (41.7) | 103 (67.3) | ||
| Death or disease progression | 12 (50.0) | 114 (74.5) | ||
| Treatment group PFS event . | PFS event rate . | HR (95% CI)∗ . | P value∗ . | |
|---|---|---|---|---|
| CLL with CR/CRi . | CLL without CR/CRi . | |||
| A + O | n = 66 | n = 113 | ||
| Death | 3 (4.5) | 19 (16.8) | 0.29 (0.13-0.65) | .0026 |
| Disease progression | 4 (6.1) | 15 (13.3) | ||
| Death or disease progression | 7 (10.6) | 34 (30.1) | ||
| A | n = 34 | n = 145 | ||
| Death | 2 (5.9) | 26 (17.9) | 0.20 (0.07-0.55) | .0017 |
| Disease progression | 2 (5.9) | 34 (23.4) | ||
| Death or disease progression | 4 (11.8) | 60 (41.4) | ||
| A ± O | n = 100 | n = 258 | ||
| Death | 5 (5.0) | 45 (17.4) | 0.23 (0.12-0.42) | <.0001 |
| Disease progression | 6 (6.0) | 49 (19.0) | ||
| Death or disease progression | 11 (11.0) | 94 (36.4) | ||
| O + Clb | n = 24 | n = 153 | ||
| Death | 2 (8.3) | 11 (7.2) | 0.34 (0.19-0.62) | .0004 |
| Disease progression | 10 (41.7) | 103 (67.3) | ||
| Death or disease progression | 12 (50.0) | 114 (74.5) | ||
Data are presented as n (%) unless otherwise specified. PFS was defined as the time from the date of randomization until disease progression or death from any cause, whichever occurred first. Patients without adequate postbaseline disease assessment were censored on the date of randomization.
A, acalabrutinib; Clb, chlorambucil; O, obinutuzumab.
HR, 95% CI, and P value based on Cox proportional hazards analysis including patients with CR/CRi as a binary factor in the model.