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Also known as ABL001
ABL001/Asciminib · 1 trial · 1 indication
Evaluation of asciminib efficacy : proportion of patients with MR2 (BCR::ABL1 IS ≤1%) level of response at 12 months.
| Arm | Type | Description |
|---|---|---|
| Asciminib (Scemblix®) | EXPERIMENTAL | Asciminib will be administered 200 mg twice a day orally. The minimum dose is 200 mg, and maximum dose is 400 mg. |
| Name | Type | Description |
|---|---|---|
| ABL001/Asciminib | DRUG | The study treatment for this clinical trial is an investigational drug called asciminib, which is marketed under the brand name Scemblix®. Asciminib is a compound that is being evaluated for its efficacy and safety in the treatment of the target condition. The minimum dose of asciminib to be administered in this study is 200 mg, while the maximum dose is 400 mg. The dose is planned as 200 mg twice a day (BID). The drug will be administered orally, allowing for convenient and non-invasive administration. |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female participants with a diagnosis of CML-CP or CML-AP ≥ 18 years of age. * Patients with CML-CP or CML-AP with history of documented T315I mutation after at least one TKI and are resista...
ABL001, also known as asciminib, is an investigational small molecule being studied for the treatment of chronic myelogenous leukemia (CML), including chronic phase CML, B-cell acute lymphoblastic leukemia, and Philadelphia chromosome positive acute lymphoblastic leukemia. It is also being evaluated in patients with hepatic impairment.
ABL001 targets the BCR-ABL1 fusion protein, which drives the growth of cancer cells in chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. By inhibiting this protein, the drug aims to block the signaling pathways that promote cancer cell proliferation.
ABL001 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in multiple oncology indications.
ABL001 is in clinical development across multiple phases. It is being studied in Phase 1, Phase 2, and Phase 3 trials for various indications including chronic myeloid leukemia and acute lymphoblastic leukemia. The drug is investigational and has not been approved by regulatory authorities.
ABL001 is being evaluated in several clinical trials, including NCT03595917, a Phase 1 study combining ABL001 with dasatinib, prednisone, and blinatumomab in BCR-ABL+ B-ALL or CML. Other trials include NCT04666259, NCT04948333, and NCT06514534, which assess asciminib in different CML patient populations.
Yes, ABL001 is the same as asciminib. The drug is referred to by both names in clinical research and development. Asciminib is the international nonproprietary name, while ABL001 is the compound code used by the developer, Novartis.