Table 2.
MMR rate at Weeks 24 and 48 comparing 40-mg b.i.d. versus 80-mg q.d. asciminib regimens from simulations of 100 patients per trial in 100 trials based on a PD model for patients not harboring the T315I mutation
| Category | 40 mg b.i.d. | 80 mg q.d. | ||
|---|---|---|---|---|
| 24-wk MMR rate (%) | 48-wk MMR rate (%) | 24-wk MMR rate (%) | 48-wk MMR rate (%) | |
| Overall | 27.6 ± 4.5 | 32.3 ± 4.8 | 24.8 ± 4.2 | 30.6 ± 4.7 |
| Baseline BCR::ABL1IS > 0.1% to 1%, ≤ 2 prior TKIs | 44.2 ± 5.2 | 45.2 ± 5.6 | 40.5 ± 4.3 | 42.2 ± 4.1 |
| Baseline BCR::ABL1IS > 0.1% to 1%, ≥ 3 prior TKIs | 42.2 ± 4.7 | 43.9 ± 4.5 | 39.2 ± 4.7 | 41.3 ± 4.8 |
| Baseline BCR::ABL1IS > 1% to 10%, ≤ 2 prior TKIs | 29.8 ± 4.3 | 34.9 ± 4.7 | 27.1 ± 4.9 | 33.2 ± 5.2 |
| Baseline BCR::ABL1IS > 1% to 10%, ≥ 3 prior TKIs | 29.4 ± 4.6 | 34.8 ± 4.9 | 25.6 ± 4.3 | 31.7 ± 5.1 |
| Baseline BCR::ABL1IS > 10% to 100%, ≤ 2 prior TKIs | 17.9 ± 3.8 | 23.9 ± 4.2 | 14.9 ± 2.9 | 21.7 ± 3.9 |
| Baseline BCR::ABL1IS > 10% to 100%, ≥ 3 prior TKIs | 17.0 ± 3.7 | 23.5 ± 4.6 | 14.7 ± 3.3 | 21.6 ± 3.6 |
Data reported as mean ± standard deviation
b.i.d. twice daily, MMR major molecular response, PD pharmacodynamic, q.d. once daily, TKI tyrosine kinase inhibitor, wk week