Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03578367 | Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response. | PHASE2 | COMPLETED | 104 | — | — | Nov 22, 2018 | Feb 26, 2025 | Apr 21, 2026 | 30 | United States, Austria +13 |
Percentage of participants still treated with the randomized treatment at 48 weeks and are in MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all participants in the asciminib add-on arms vs imatinib arm.
| Arm | Type | Description |
|---|---|---|
| Asciminib 60mg QD + Imatinib 400mg QD | EXPERIMENTAL | Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily |
| Asciminib 40mg QD + Imatinib 400mg QD | EXPERIMENTAL | Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily |
| Imatinib 400mg QD | ACTIVE_COMPARATOR | Imatinib 400 mg taken once daily |
| Nilotinib 300mg BID | ACTIVE_COMPARATOR | Nilotinib 300 mg taken twice daily |
| Asciminib 80mg QD (ASAC) | EXPERIMENTAL | Asciminib 80 mg taken once daily |
| Name | Type | Description |
|---|---|---|
| Asciminib add-on | DRUG | Asciminib was supplied as 40 mg and 20 mg tablets and taken orally once daily. |
| Imatinib | DRUG | Imatinib was supplied as 400 mg and 100 mg tablets and taken orally once daily. |
| Nilotinib | DRUG | Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules and taken orally twice daily. |
| Asciminib 80mg QD (asciminib single agent (ASAC)) | DRUG | Asciminib was supplied as 40 mg and 20 mg tablets and taken orally once daily (in the fasted state) on a continuous schedule (QD). |
Inclusion Criteria: * Male or female patients ≥ 18 years of age with a confirmed diagnosis of CML-CP. * Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 400 mg QD at randomization and had no dose change in the past three months)...