Therapy Detail
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| Therapy Name | Asciminib |
| Synonyms | |
| Therapy Description |
Scemblix (asciminib) is an allosteric inhibitor of BCR-ABL that binds to a unique location outside the ATP binding site, resulting in decreased BCR-ABL kinase activity and reduced tumor growth (PMID: 31543464, PMID: 31826340). Scemblix (asciminib) is FDA approved for use in patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), and in Ph+ CML patients in CP after two or more tyrosine kinase inhibitor treatments, and in adult patients with Ph+ CML in CP harboring ABL1 T315I (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Asciminib | Scemblix | ABL001|ABL-001 | BCR-ABL Inhibitor 32 | Scemblix (asciminib) is an allosteric inhibitor of BCR-ABL that binds to a unique location outside the ATP binding site, resulting in decreased BCR-ABL kinase activity and reduced tumor growth (PMID: 31543464, PMID: 31826340). Scemblix (asciminib) is FDA approved for use in patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), and in Ph+ CML patients in CP after two or more tyrosine kinase inhibitor treatments, and in adult patients with Ph+ CML in CP harboring ABL1 T315I (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ABL1 rearrange | myeloid neoplasm | sensitive | Asciminib | Guideline | Actionable | Scemblix (asciminib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an ABL1 rearrangement (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05384587 | Phase II | Asciminib | Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE) | Active, not recruiting | USA | 0 |
| NCT06236724 | Phase II | Asciminib | Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase. | Recruiting | USA | 0 |
| NCT06308588 | Phase II | Asciminib Asciminib + Blinatumomab | Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia | Recruiting | USA | 0 |
| NCT04971226 | Phase III | Asciminib Bosutinib Imatinib Dasatinib Nilotinib | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP | Active, not recruiting | USA | SWE | SVK | NOR | NLD | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BGR | BEL | AUT | AUS | 8 |
| NCT02081378 | Phase I | Asciminib Asciminib + Imatinib Asciminib + Dasatinib Asciminib + Nilotinib | A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL | Completed | USA | NLD | ITA | FRA | ESP | DEU | AUS | 3 |
| NCT04877522 | FDA approved | Asciminib Bosutinib Dasatinib Nilotinib Asciminib + Imatinib | Asciminib Roll-over Study | Recruiting | USA | TUR | ROU | POL | LBN | ITA | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BGR | AUT | ARG | 9 |
| NCT04948333 | Phase III | Asciminib | Asciminib Treatment Optimization in >= 3rd Line CML-CP. | Active, not recruiting | POL | ITA | GRC | GBR | FRA | ESP | DEU | CAN | BRA | AUT | ARG | 5 |
| NCT03106779 | Phase III | Bosutinib Asciminib | Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs | Active, not recruiting | USA | TUR | ROU | NLD | LBN | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | AUS | ARG | 6 |
| NCT05143840 | Phase II | Asciminib Asciminib + Nilotinib | Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (ALERTCML) | Recruiting | USA | 0 |
| NCT04925479 | Phase Ib/II | Asciminib | Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia | Recruiting | USA | TUR | POL | NLD | ITA | HUN | GRC | FRA | DEU | 5 |
| NCT04666259 | Phase III | Asciminib | Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation (AIM4CML) | Completed | USA | 0 |
| NCT05456191 | Phase III | Asciminib Nilotinib | A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (>=18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) (ASC4START) | Active, not recruiting | USA | TUR | SVK | ROU | NLD | ITA | HUN | GRC | GBR | FRA | DEU | CZE | CHE | CAN | BGR | ARG | 8 |
| NCT04216563 | Phase II | Asciminib | ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor | Active, not recruiting | USA | 0 |
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