Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABL001 (asciminib)
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 being studied in chronic myeloid leukemia (CML) in chronic phase. Specifically, it is added to imatinib for patients previously treated with imatinib who have not achieved a deep molecular response. This combination approach aims to improve treatment outcomes for CML patients who need deeper responses.
Asciminib add-on targets the ABL1 kinase and the BCR-ABL1 fusion protein, which drives chronic myeloid leukemia. It is a small molecule inhibitor that binds to the ABL1 myristoyl pocket, offering a distinct mechanism of action compared to ATP-competitive inhibitors. This target specificity is central to its therapeutic potential in CML.
Asciminib add-on is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS. The company is evaluating this combination therapy in clinical trials for chronic myeloid leukemia.
Asciminib add-on is in Phase 2 clinical development. It has been tested in a completed Phase 2 trial, and further studies may be planned. As an investigational therapy, it has not been approved by regulatory agencies for this specific add-on indication.
Asciminib add-on has been evaluated in a Phase 2 clinical trial, NCT03578367. This study was completed and enrolled 104 patients with chronic myeloid leukemia in chronic phase who had previously received imatinib and had not achieved a deep molecular response. The trial was active-controlled and randomized.