Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asciminib add-on · 1 trial · 4 indications
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)...
Asciminib add-on is used for chronic myeloid leukemia (CML), specifically for patients in chronic phase who have been previously treated with imatinib and have not achieved a deep molecular response. It is an investigational small molecule being studied in combination with imatinib.
Asciminib add-on is being developed by Novartis AG, which trades under the ticker NVS. The company is studying this small molecule as an add-on therapy to imatinib for chronic myeloid leukemia in chronic phase.
Asciminib add-on is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under clinical investigation for chronic myeloid leukemia.
Asciminib add-on has one completed Phase 2 clinical trial, identified as NCT03578367. This study evaluated the efficacy and safety of asciminib in combination with imatinib in patients with chronic myeloid leukemia in chronic phase who had not achieved a deep molecular response after prior imatinib treatment.
Asciminib add-on refers to the combination of asciminib with imatinib, as studied in the Phase 2 trial NCT03578367. The trial specifically investigated this add-on regimen in patients with chronic myeloid leukemia who had not achieved a deep molecular response on imatinib alone.