Comparison of demographic data, efficacy, and safety of acalabrutinib vs ibrutinib in treatment-naïve CLL
| . | ACE-CL-001 . | ELEVATE-TN . | ALLIANCE . | RESONATE-2 . |
|---|---|---|---|---|
| Agent . | Acalabrutinib . | Acalabrutinib . | Ibrutinib . | Ibrutinib . |
| n | 99 | 179 | 182 | 136 |
| Median age, y | 64 | 70 | 71 | 73 |
| Median CrCl (mL/min) | NR | 75 | 69 | NR |
| Rai stage III/IV, % | 47 | 48 | 54 | 44 |
| Unmutated IGHV, % | 62 | 58 | 63 | 57 |
| FISH del 17p, % | 10 | 10 | 5 | 0 |
| ORR/CR, % | 97 / 7 | 86/1 | 93/7 | 92/30 |
| Median follow-up, mo | 53 | 28 | 38 | 60 |
| PFS, % | 4-y PFS 96 | 2-y PFS 87 | 2-y PFS 87 | 4-y PFS 76 |
| Neutropenia grade ≥3, % | 9 | 10 | 15 | 13 |
| Bleeding grade ≥3, % | 3 | 2 | 2 | 6 |
| Atrial fibrillation, any grade (≥3), % | 5 (2) | 4 (0) | 17 (9) | 16 (5) |
| Infection grade ≥3, % | 15 | 14 | 20 | 23 |
| SPM, % | 26 | 9 | 13 | NR |
| References | 1 | 8 | 5 | 6,9 |
| . | ACE-CL-001 . | ELEVATE-TN . | ALLIANCE . | RESONATE-2 . |
|---|---|---|---|---|
| Agent . | Acalabrutinib . | Acalabrutinib . | Ibrutinib . | Ibrutinib . |
| n | 99 | 179 | 182 | 136 |
| Median age, y | 64 | 70 | 71 | 73 |
| Median CrCl (mL/min) | NR | 75 | 69 | NR |
| Rai stage III/IV, % | 47 | 48 | 54 | 44 |
| Unmutated IGHV, % | 62 | 58 | 63 | 57 |
| FISH del 17p, % | 10 | 10 | 5 | 0 |
| ORR/CR, % | 97 / 7 | 86/1 | 93/7 | 92/30 |
| Median follow-up, mo | 53 | 28 | 38 | 60 |
| PFS, % | 4-y PFS 96 | 2-y PFS 87 | 2-y PFS 87 | 4-y PFS 76 |
| Neutropenia grade ≥3, % | 9 | 10 | 15 | 13 |
| Bleeding grade ≥3, % | 3 | 2 | 2 | 6 |
| Atrial fibrillation, any grade (≥3), % | 5 (2) | 4 (0) | 17 (9) | 16 (5) |
| Infection grade ≥3, % | 15 | 14 | 20 | 23 |
| SPM, % | 26 | 9 | 13 | NR |
| References | 1 | 8 | 5 | 6,9 |
CrCl, creatinine clearance; FISH, fluorescence in situ hybridization; IGHV, immunoglobulin heavy-chain variable region; ORR/CR, overall response rate/complete response.