Demographic and clinical characteristics of patients at baseline
| Variable . | Asciminib 40 mg twice daily (n = 157) . | Bosutinib 500 mg once daily (n = 76) . | All patients (N = 233) . |
|---|---|---|---|
| Median age (range), y | 52.0 (24-83) | 52.0 (19-77) | 52.0 (19-83) |
| Female, n (%) | 75 (47.8) | 45 (59.2) | 120 (51.5) |
| Male, n (%) | 82 (52.2) | 31 (40.8) | 113 (48.5) |
| Race, n (%) | |||
| White | 118 (75.2) | 56 (73.7) | 174 (74.7) |
| Asian | 22 (14.0) | 11 (14.5) | 33 (14.2) |
| Black or African American | 8 (5.1) | 2 (2.6) | 10 (4.3) |
| Native American | 1 (0.6) | 0 | 1 (0.4) |
| Other | 5 (3.2) | 7 (9.2) | 12 (5.2) |
| Unknown | 3 (1.9) | 0 | 3 (1.3) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 15 (9.6) | 17 (22.4) | 32 (13.7) |
| Not Hispanic or Latino | 102 (65.0) | 43 (56.6) | 145 (62.2) |
| Not reported | 23 (14.6) | 11 (14.5) | 34 (14.6) |
| Unknown | 17 (10.8) | 5 (6.6) | 22 (9.4) |
| ECOG performance status, n (%) | |||
| 0 | 126 (80.3) | 62 (81.6) | 188 (80.7) |
| 1 | 28 (17.8) | 14 (18.4) | 42 (18.0) |
| 2 | 2 (1.3) | 0 | 2 (0.9) |
| Missing | 1 (0.6) | 0 | 1 (0.4) |
| MCyR | 46 (29.3) | 22 (28.9) | 68 (29.2) |
| Prior TKIs, n (%) | |||
| Imatinib | 130 (82.8) | 63 (82.9) | 193 (82.8) |
| Nilotinib | 104 (66.2) | 56 (73.7) | 160 (68.7) |
| Dasatinib | 131 (83.4) | 65 (85.5) | 196 (84.1) |
| Ponatinib | 23 (14.6) | 18 (23.7) | 41 (17.6) |
| Radotinib | 4 (2.5) | 2 (2.6) | 6 (2.6) |
| Other | 5 (3.2) | 4 (5.3) | 9 (3.9) |
| No. of lines of prior TKI therapy, n (%)* | |||
| 2 | 82 (52.2) | 30 (39.5) | 112 (48.1) |
| 3 | 44 (28.0) | 29 (38.2) | 73 (31.3) |
| 4 | 24 (15.3) | 10 (13.2) | 34 (14.6) |
| ≥5 | 7 (4.5) | 7 (9.2) | 14 (6.0) |
| Reason for discontinuation of last TKI, n (%) | |||
| Lack of efficacy† | 95 (60.5) | 54 (71.1) | 149 (63.9) |
| Lack of tolerability | 59 (37.6) | 22 (28.9) | 81 (34.8) |
| Other‡ | 3 (1.9) | 0 | 3 (1.3) |
| BCR-ABL1IS at baseline, n (%) | |||
| >0.1% to ≤1%§ | 15 (9.6) | 4 (5.3) | NA |
| >1% to ≤10% | 45 (28.7) | 23 (30.3) | NA |
| >10% | 97 (61.8) | 49 (64.5) | NA |
| Patients with any BCR-ABL1 mutation, n (%) | 20 (12.7) | 10 (13.2) | 30 (12.9) |
| Patients with multiple BCR-ABL1 mutations, n (%) | 3 (1.9) | 0 | 3 (1.3) |
| Variable . | Asciminib 40 mg twice daily (n = 157) . | Bosutinib 500 mg once daily (n = 76) . | All patients (N = 233) . |
|---|---|---|---|
| Median age (range), y | 52.0 (24-83) | 52.0 (19-77) | 52.0 (19-83) |
| Female, n (%) | 75 (47.8) | 45 (59.2) | 120 (51.5) |
| Male, n (%) | 82 (52.2) | 31 (40.8) | 113 (48.5) |
| Race, n (%) | |||
| White | 118 (75.2) | 56 (73.7) | 174 (74.7) |
| Asian | 22 (14.0) | 11 (14.5) | 33 (14.2) |
| Black or African American | 8 (5.1) | 2 (2.6) | 10 (4.3) |
| Native American | 1 (0.6) | 0 | 1 (0.4) |
| Other | 5 (3.2) | 7 (9.2) | 12 (5.2) |
| Unknown | 3 (1.9) | 0 | 3 (1.3) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 15 (9.6) | 17 (22.4) | 32 (13.7) |
| Not Hispanic or Latino | 102 (65.0) | 43 (56.6) | 145 (62.2) |
| Not reported | 23 (14.6) | 11 (14.5) | 34 (14.6) |
| Unknown | 17 (10.8) | 5 (6.6) | 22 (9.4) |
| ECOG performance status, n (%) | |||
| 0 | 126 (80.3) | 62 (81.6) | 188 (80.7) |
| 1 | 28 (17.8) | 14 (18.4) | 42 (18.0) |
| 2 | 2 (1.3) | 0 | 2 (0.9) |
| Missing | 1 (0.6) | 0 | 1 (0.4) |
| MCyR | 46 (29.3) | 22 (28.9) | 68 (29.2) |
| Prior TKIs, n (%) | |||
| Imatinib | 130 (82.8) | 63 (82.9) | 193 (82.8) |
| Nilotinib | 104 (66.2) | 56 (73.7) | 160 (68.7) |
| Dasatinib | 131 (83.4) | 65 (85.5) | 196 (84.1) |
| Ponatinib | 23 (14.6) | 18 (23.7) | 41 (17.6) |
| Radotinib | 4 (2.5) | 2 (2.6) | 6 (2.6) |
| Other | 5 (3.2) | 4 (5.3) | 9 (3.9) |
| No. of lines of prior TKI therapy, n (%)* | |||
| 2 | 82 (52.2) | 30 (39.5) | 112 (48.1) |
| 3 | 44 (28.0) | 29 (38.2) | 73 (31.3) |
| 4 | 24 (15.3) | 10 (13.2) | 34 (14.6) |
| ≥5 | 7 (4.5) | 7 (9.2) | 14 (6.0) |
| Reason for discontinuation of last TKI, n (%) | |||
| Lack of efficacy† | 95 (60.5) | 54 (71.1) | 149 (63.9) |
| Lack of tolerability | 59 (37.6) | 22 (28.9) | 81 (34.8) |
| Other‡ | 3 (1.9) | 0 | 3 (1.3) |
| BCR-ABL1IS at baseline, n (%) | |||
| >0.1% to ≤1%§ | 15 (9.6) | 4 (5.3) | NA |
| >1% to ≤10% | 45 (28.7) | 23 (30.3) | NA |
| >10% | 97 (61.8) | 49 (64.5) | NA |
| Patients with any BCR-ABL1 mutation, n (%) | 20 (12.7) | 10 (13.2) | 30 (12.9) |
| Patients with multiple BCR-ABL1 mutations, n (%) | 3 (1.9) | 0 | 3 (1.3) |
ECOG, Eastern Cooperative Oncology Group; NA, not available.
The number of lines of prior TKI therapy was based on the sequence of treatments.
Lack of efficacy criteria were based on 2013 ELN recommendations (see supplemental Appendix for details).
Includes study medication wrongly assigned, lack of efficacy and tolerability, and optimal response not reached after 5 y of treatment.
All patients with BCR-ABL1IS <1% at baseline were intolerant to the last TKI, except 1 in the asciminib arm (who deviated from the protocol).