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 30 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
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 | ITA | GBR | FRA | DEU | CAN 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 | ITA | GBR | FRA | ESP | DEU | CAN | AUS 17
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 19
NCT04925479 Phase Ib/II Asciminib Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia Recruiting USA | ITA | FRA | DEU 10
NCT04877522 FDA approved Asciminib Bosutinib Dasatinib Nilotinib Asciminib + Imatinib Asciminib Roll-over Study Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT 17
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 | ITA | FRA | ESP | DEU | AUS 4
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
NCT05143840 Phase II Asciminib Asciminib + Nilotinib Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (ALERTCML) Recruiting USA 0
NCT05384587 Phase II Asciminib Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE) Recruiting USA 0
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


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