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 Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (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 31 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 Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (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
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
NCT05384587 Phase II Asciminib Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE) 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 | NLD | ITA | FRA | DEU 9
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 | ITA | GBR | FRA | ESP | DEU | CAN | AUT 17
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS 16
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
NCT04948333 Phase III Asciminib Asciminib Treatment Optimization in >= 3rd Line CML-CP. Active, not recruiting ITA | GBR | FRA | ESP | DEU | CAN | AUT 9
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 18
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 Not yet recruiting 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) Recruiting USA | NLD | ITA | GBR | FRA | DEU | CAN 17
NCT04666259 Phase III Asciminib Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation (AIM4CML) Active, not recruiting USA 0
NCT05143840 Phase II Asciminib Asciminib + Nilotinib Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (ALERTCML) Recruiting USA 0


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