Table 4.
Categorical Response Shift from Baseline in Patients with Chronic-Phase CML Treated with Asciminib.*
| Variable | No T315I Mutation | T315I Mutation | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline BCR-ABL1IS† | Baseline BCR-ABL1IS† | ||||||||
| ≤0.01% (N = 6) | >0.01 to 0.1% (N = 13) | >0.1 to 1% (N = 22) | >1 to 10% (N = 21) | >10% (N = 42) | >0.01 to 0.1% (N = 1) | >0.1 to 1% (N = 2) | >1 to 10% (N = 5) | >10% (N = 19) | |
| Post-treatment BCR-ABL1IS by 6 mo | |||||||||
| Patients who could be evaluated‡ | 6 | 13 | 23 | 18 | 39 | 1 | 1 | 5 | 13 |
| Distribution — no. of patients (%)§ | |||||||||
| ≤0.01% | 6 (100) | 4 (31) | 5 (22) | 4 (22) | 1 (3) | 1 (100) | 0 | 0 | 0 |
| >0.01 to 0.1% | 0 | 8 (62) | 6 (26) | 1 (6) | 2 (5) | 0 | 1 (100) | 2 (40) | 1 (8) |
| >0.1 to 1% | 0 | 1 (8) | 12 (52) | 12 (67) | 7 (18) | 0 | 0 | 2 (40) | 1 (8) |
| >1 to 10% | 0 | 0 | 0 | 1 (6) | 12 (31) | 0 | 0 | 1 (20) | 2 (15) |
| >10% | 0 | 0 | 0 | 0 | 17 (44) | 0 | 0 | 0 | 9 (69) |
| Post-treatment BCR-ABL1IS by 12 mo | |||||||||
| Patients who could be evaluated‡ | 6 | 13 | 21 | 17 | 34 | 1 | 1 | 5 | 11 |
| Distribution — no. of patients (%)§ | |||||||||
| ≤0.01% | 6 (100) | 5 (38) | 6 (29) | 5 (29) | 1 (3) | 1 (100) | 0 | 2 (40) | 0 |
| >0.01 to 0.1% | 0 | 7 (54) | 6 (29) | 3 (18) | 5 (15) | 0 | 1 (100) | 0 | 1 (9) |
| >0.1 to 1% | 0 | 1 (8) | 9 (43) | 8 (47) | 6 (18) | 0 | 0 | 2 (40) | 1 (9) |
| >1 to 10% | 0 | 0 | 0 | 1 (6) | 12 (35) | 0 | 0 | 1 (20) | 1 (9) |
| >10% | 0 | 0 | 0 | 0 | 10 (29) | 0 | 0 | 0 | 8 (73) |
Percentages may not total 100 because of rounding. BCR-ABL1IS denotes the ratio of BCR-ABL1 to ABL1 measured on the International Scale.
The number of patients is the number who received at least one dose of asciminib in each category of BCR-ABL1 transcript level at baseline. A total of 10 patients with chronic-phase CML (9 without a T315I mutation and 1 with a T315I mutation) had a missing BCR-ABL1IS value at baseline.
Shown is the number of patients who could be evaluated in each category of baseline BCR-ABL1 transcript level who had undergone assessment of molecular response at 6 (or 12) months after treatment or who had a major molecular response within 6 (or 12) months. For a detailed definition of molecular response, see the Methods section in the Supplementary Appendix. Response assessment is reported only for patients with the b2a2 or b3a2 transcripts.
Percentages were calculated on the basis of the number of patients who could be evaluated.