On January 8, Novartis announced,ScembliX (asciminib) in newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) in adult patients: Phase III ASC4FIRST Study Shows Positive Results in Initial Analysis.Scemblix ShowsExitSuperior to standard treatmentTyrosine Kinase Inhibitor (TKI)The main molecular response (MMR).Asciminib is a drug specifically targeting the ABL myristoyl pocket (STAMP) drugs. As a STAMP inhibitor, asciminib binds to a different site on BCR-ABL1 than common TKIs, which may help address the issues of TKI resistance and intolerance in later-line CML treatment. In 2021,In October, the FDA granted accelerated approval to Scemblix for the treatment of adult patients with Ph+ CML-CP who have received ≥ 2 prior TKI therapies (based on the Week 24 MMR rate), and full approval for the treatment of adult patients with Ph+ CML-CP carrying the T315I mutation.ASC4FIRST Study is aRandomized, Multicenter, Open-LabelPhase III clinical trial,AlsoIs the first and only one that meets the standardTreatment CML'sFirst-generation and second-generation TKI progressionHeadCorrectIIIPhase trial, enrolling a total of 405 subjects.The primary endpoints of the study include at 48 weeks,AndTKIs selected by researchers (IMasitinib, nilotinib, dasatinib, and bosutinib) as well as imatinib compared to pre-randomized selection TKI, once daily 80mgProportion of patients in the Scemblix treatment group who achieved MMR.Major Molecular ResponseThe definition of BCR-ABL1 transcriptQuantity ≤ 0.1%(One-thousandth). Key secondary endpoints included the proportion of patients achieving MMR at Week 96 and the proportion of patients discontinuing treatment due to AE, etc.The results showed that the study met the dual primary endpoints,ScemblixThe MMR rate in Week 48 was better thanTKIs selected by researchers (IMasitinib, nilotinib, dasatinib, and bosutinib), with clinical and statistical significance. Meanwhile,Scemblix also demonstrated good safety and tolerability, with fewer adverse events (AE) and treatment discontinuations, and no new safety signals observed.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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