Baseline characteristics of the acalabrutinib plus obinutuzumab and acalabrutinib monotherapy arms in ELEVATE-TN vs the zanubrutinib arm in SEQUOIA
| Baseline variable, % . | Acalabrutinib plus obinutuzumab before matching (N = 162) . | Acalabrutinib plus obinutuzumab after matching, (ESS = 124)∗ . | Acalabrutinib monotherapy before matching (N = 163) . | Acalabrutinib monotherapy after matching, (ESS = 105)† . | Zanubrutinib (N = 241) . |
|---|---|---|---|---|---|
| Age | |||||
| Median, y | 70.0 | 69.6 | 70.0 | 69.6 | 70.0 |
| <65 y | 18.5 | 18.7 | 14.1 | 18.7 | 18.7 |
| Sex, female | 34.6 | 34.5 | 36.2 | 38.9 | 36.1 |
| Race, White | 91.4 | 92.6 | 95.1 | 92.8 | 91.7 |
| Region, Europe | 55.6 | 53.3 | 50.3 | 43.3 | 72.2 |
| Median time from initial diagnosis, mo | 30.6 | 31.8 | 25.4 | 30.4 | 31.3 |
| Cancer type, CLL | 100.0 | 100.0 | 100.0 | 100.0 | 91.7† |
| Beta-2 microglobulin, >3.5 mg/L | 74.1 | 56.0 | 79.1 | 56.0 | 56.0 |
| Binet stage, A/B | 56.2 | 71.0 | 58.9 | 71.0 | 71.0 |
| ECOG PS, 0-1 | 95.7 | 93.8 | 92.6 | 93.8 | 93.8 |
| Bulky disease, ≥5 cm | 25.9 | 28.6 | 38.7 | 28.6 | 28.6 |
| Cytopenia at baseline | 51.9 | 42.3 | 47.2 | 42.3 | 42.3 |
| Mutation status | |||||
| Del(11q) | 18.5 | 17.8 | 18.4 | 17.8 | 17.8 |
| Del(13q) | 53.7 | 58.4 | 61.3 | 70.1 | 56.4 |
| Trisomy 12 | 24.7 | 18.7 | 29.4 | 18.7 | 18.7 |
| FISH abnormalities, absent | 24.1 | 24.6 | 11.0 | 11.3 | 23.2 |
| IGHV, unmutated | 58.0 | 51.9 | 65.6 | 51.9 | 51.9 |
| TP53, mutated | 4.9 | 6.2 | 4.3 | 6.2 | 6.2 |
| Complex karyotype‡ | 12.3 | 13.5 | 13.5 | 14.5 | NR |
| Baseline variable, % . | Acalabrutinib plus obinutuzumab before matching (N = 162) . | Acalabrutinib plus obinutuzumab after matching, (ESS = 124)∗ . | Acalabrutinib monotherapy before matching (N = 163) . | Acalabrutinib monotherapy after matching, (ESS = 105)† . | Zanubrutinib (N = 241) . |
|---|---|---|---|---|---|
| Age | |||||
| Median, y | 70.0 | 69.6 | 70.0 | 69.6 | 70.0 |
| <65 y | 18.5 | 18.7 | 14.1 | 18.7 | 18.7 |
| Sex, female | 34.6 | 34.5 | 36.2 | 38.9 | 36.1 |
| Race, White | 91.4 | 92.6 | 95.1 | 92.8 | 91.7 |
| Region, Europe | 55.6 | 53.3 | 50.3 | 43.3 | 72.2 |
| Median time from initial diagnosis, mo | 30.6 | 31.8 | 25.4 | 30.4 | 31.3 |
| Cancer type, CLL | 100.0 | 100.0 | 100.0 | 100.0 | 91.7† |
| Beta-2 microglobulin, >3.5 mg/L | 74.1 | 56.0 | 79.1 | 56.0 | 56.0 |
| Binet stage, A/B | 56.2 | 71.0 | 58.9 | 71.0 | 71.0 |
| ECOG PS, 0-1 | 95.7 | 93.8 | 92.6 | 93.8 | 93.8 |
| Bulky disease, ≥5 cm | 25.9 | 28.6 | 38.7 | 28.6 | 28.6 |
| Cytopenia at baseline | 51.9 | 42.3 | 47.2 | 42.3 | 42.3 |
| Mutation status | |||||
| Del(11q) | 18.5 | 17.8 | 18.4 | 17.8 | 17.8 |
| Del(13q) | 53.7 | 58.4 | 61.3 | 70.1 | 56.4 |
| Trisomy 12 | 24.7 | 18.7 | 29.4 | 18.7 | 18.7 |
| FISH abnormalities, absent | 24.1 | 24.6 | 11.0 | 11.3 | 23.2 |
| IGHV, unmutated | 58.0 | 51.9 | 65.6 | 51.9 | 51.9 |
| TP53, mutated | 4.9 | 6.2 | 4.3 | 6.2 | 6.2 |
| Complex karyotype‡ | 12.3 | 13.5 | 13.5 | 14.5 | NR |
Data are reported as percentages (%), unless otherwise specified.
FISH, fluorescent in situ hybridization; IGHV, immunoglobulin heavy chain variable gene; NR, not reported; PS, performance status; TP53, tumor protein 53.
The number of patients was calculated using the rescaled weights and therefore sum to the efficacy analysis sample size for acalabrutinib plus obinutuzumab (n = 162) and acalabrutinib monotherapy (n = 163).
The remaining 8.3% of patients had SLL.
Complex karyotype was defined as ≥3 cytogenetic abnormalities based on karyotyping by the central laboratory.