TTNTD for patients with CLL and/or SLL treated with acalabrutinib or ibrutinib
| . | Number of patients∗ . | Total events, n (%) . | Events at 3 mo, n (%) . | Events at 6 mo, n (%) . | Events at 12 mo, n (%) . | Events at 18 mo, n (%) . | Median TTNTD, mo (95% CI) . | Mean TTNTD†, mo (95% CI) . | HR (95% CI) . |
|---|---|---|---|---|---|---|---|---|---|
| Unweighted‡ | |||||||||
| All patients on acalabrutinib | 353 | 76 (21.5) | 35 (9.9) | 62 (17.6) | 71 (20.1) | 74 (21.0) | NR (25.2-NR) | 24.2 (21.8-26.5) | 1.20 (0.94-1.54) |
| All patients on ibrutinib | 2244 | 711 (31.7) | 200 (8.9) | 326 (14.5) | 497 (22.1) | 585 (26.1) | NR (36.4-NR) | 26.5 (25.8-27.1) | ref. |
| ATT weighted§ | |||||||||
| All patients on acalabrutinib | 353 | 76 (21.5) | 35 (9.9) | 62 (17.6) | 71 (20.1) | 74 (21.0) | NR (25.2-NR) | 24.2 (21.8-26.5) | 0.75 (0.56-1.00) |
| All patients on ibrutinib | 364 | 106 (29.1) | 52 (14.3) | 76 (20.9) | 98 (26.9) | 102 (28.0) | 27.3 (21.3-31.2) | 22.7 (21.2-24.3) | ref. |
| ATT weighted with additional adjustmentǁ | |||||||||
| All patients on acalabrutinib | 353 | 76 (21.5) | 35 (9.9) | 62 (17.6) | 71 (20.1) | 74 (21.0) | NR (25.2-NR) | 24.2 (21.8-26.5) | 0.62 (0.43-0.88) |
| All patients on ibrutinib | 364 | 106 (29.1) | 52 (14.3) | 76 (20.9) | 98 (26.9) | 102 (28.0) | 27.3 (21.3-31.2) | 22.7 (21.2-24.3) | ref. |
| . | Number of patients∗ . | Total events, n (%) . | Events at 3 mo, n (%) . | Events at 6 mo, n (%) . | Events at 12 mo, n (%) . | Events at 18 mo, n (%) . | Median TTNTD, mo (95% CI) . | Mean TTNTD†, mo (95% CI) . | HR (95% CI) . |
|---|---|---|---|---|---|---|---|---|---|
| Unweighted‡ | |||||||||
| All patients on acalabrutinib | 353 | 76 (21.5) | 35 (9.9) | 62 (17.6) | 71 (20.1) | 74 (21.0) | NR (25.2-NR) | 24.2 (21.8-26.5) | 1.20 (0.94-1.54) |
| All patients on ibrutinib | 2244 | 711 (31.7) | 200 (8.9) | 326 (14.5) | 497 (22.1) | 585 (26.1) | NR (36.4-NR) | 26.5 (25.8-27.1) | ref. |
| ATT weighted§ | |||||||||
| All patients on acalabrutinib | 353 | 76 (21.5) | 35 (9.9) | 62 (17.6) | 71 (20.1) | 74 (21.0) | NR (25.2-NR) | 24.2 (21.8-26.5) | 0.75 (0.56-1.00) |
| All patients on ibrutinib | 364 | 106 (29.1) | 52 (14.3) | 76 (20.9) | 98 (26.9) | 102 (28.0) | 27.3 (21.3-31.2) | 22.7 (21.2-24.3) | ref. |
| ATT weighted with additional adjustmentǁ | |||||||||
| All patients on acalabrutinib | 353 | 76 (21.5) | 35 (9.9) | 62 (17.6) | 71 (20.1) | 74 (21.0) | NR (25.2-NR) | 24.2 (21.8-26.5) | 0.62 (0.43-0.88) |
| All patients on ibrutinib | 364 | 106 (29.1) | 52 (14.3) | 76 (20.9) | 98 (26.9) | 102 (28.0) | 27.3 (21.3-31.2) | 22.7 (21.2-24.3) | ref. |
ref., reference group.
TTNTD was defined as the time from the initiation of the index treatment to initiation of a new line of therapy or death due to any reason. Data of patients who had not initiated a new line of therapy after their index treatment were censored at the last confirmed clinical activity date based on the available data (ie, structured data and unstructured data through chart abstraction).
Five patients in the ibrutinib cohort had a treatment discontinuation date that was the same as the index date (ie, initiation of ibrutinib) and were removed from the analysis.
Mean TTNTD was calculated as the area under the Kaplan-Meier curve until the end of follow-up.
Median follow-up time for the acalabrutinib and ibrutinib cohorts was 7.1 and 17.5 months, respectively, among the overall study population. Mean (min, max) follow-up time for the acalabrutinib and ibrutinib cohorts was 8.6 (0.1, 34.7) months and 17.8 (0.2, 37.9) months, respectively.
The following characteristics were adjusted for using ATT weights: age, sex, race, geographic region, year of ibrutinib or acalabrutinib initiation, year of CLL/SLL diagnosis, line of therapy, Rai stage, modified Quan-CCI score, atrial fibrillation, ECOG performance status, and use of anticoagulants. The median follow-up time for the ATT-weighted acalabrutinib and ibrutinib cohorts was 7.1 and 7.6 months, respectively, among the overall study population. Mean (minimum, maximum) follow-up time for the ATT-weighted acalabrutinib and ibrutinib cohorts was 8.6 (0.1, 34.7) months and 9.1 (0.02, 37.7) months, respectively.
Prior BTKi use was further controlled for in a doubly robust Cox PH model.