Patient disposition
| Variable, n (%) . | Asciminib 40 mg twice daily (N = 157) . | Bosutinib 500 mg once daily (N = 76) . |
|---|---|---|
| Patients randomized | ||
| Treated | 156 (99.4) | 76 (100.0) |
| Not treated | 1 (0.6)∗ | 0 |
| Completed treatment | 77 (49.0) | 8 (10.5) |
| Switched to asciminib | NA | 25 (32.9) |
| Discontinued treatment | 79 (50.3) | 68 (89.5) |
| Before week 24 | 26 (16.6) | 25 (32.9) |
| Week 24 to before week 48 | 25 (15.9) | 29 (38.2) |
| Week 48 to before week 96 | 17 (10.8) | 3 (3.9) |
| After week 96 | 11 (7.0) | 11 (14.5) |
| Reason for discontinuation | ||
| Lack of efficacy | 40 (25.5) | 28 (36.8) |
| Physician decision | 13 (8.3) | 7 (9.2) |
| AEs | 11 (7.0) | 21 (27.6) |
| Patient/guardian decision | 6 (3.8) | 7 (9.2) |
| Death | 4 (2.5) | 0 |
| Progressive disease | 2 (1.3) | 3 (3.9) |
| Loss to follow-up | 1 (0.6) | 2 (2.6) |
| Pregnancy | 1 (0.6)† | 0 |
| Protocol deviation | 1 (0.6) | 0 |
| Variable, n (%) . | Asciminib 40 mg twice daily (N = 157) . | Bosutinib 500 mg once daily (N = 76) . |
|---|---|---|
| Patients randomized | ||
| Treated | 156 (99.4) | 76 (100.0) |
| Not treated | 1 (0.6)∗ | 0 |
| Completed treatment | 77 (49.0) | 8 (10.5) |
| Switched to asciminib | NA | 25 (32.9) |
| Discontinued treatment | 79 (50.3) | 68 (89.5) |
| Before week 24 | 26 (16.6) | 25 (32.9) |
| Week 24 to before week 48 | 25 (15.9) | 29 (38.2) |
| Week 48 to before week 96 | 17 (10.8) | 3 (3.9) |
| After week 96 | 11 (7.0) | 11 (14.5) |
| Reason for discontinuation | ||
| Lack of efficacy | 40 (25.5) | 28 (36.8) |
| Physician decision | 13 (8.3) | 7 (9.2) |
| AEs | 11 (7.0) | 21 (27.6) |
| Patient/guardian decision | 6 (3.8) | 7 (9.2) |
| Death | 4 (2.5) | 0 |
| Progressive disease | 2 (1.3) | 3 (3.9) |
| Loss to follow-up | 1 (0.6) | 2 (2.6) |
| Pregnancy | 1 (0.6)† | 0 |
| Protocol deviation | 1 (0.6) | 0 |
Presented at the 65th ASH Annual Meeting & Exposition. Poster 4536. Reprinted from Mauro et al.24
NA, not applicable.
One patient developed cytopenia after randomization and was not treated per investigator’s decision.
The patient who became pregnant received asciminib for ∼2 years and 9 months. Treatment was discontinued 5 days after the diagnosis, and ∼14 weeks later an abortion was induced because of suspicion of fetal anomaly (karyotype 45,X was later confirmed).