Asciminib monotherapy for newly diagnosed chronic myeloid leukemia in chronic phase: the ASC4FIRST phase III trial.

Abstract

Asciminib is the first BCR::ABL1 inhibitor that works by Specifically Targeting the ABL Myristoyl Pocket (STAMP). Asciminib has shown favorable efficacy and safety in patients with chronic myeloid leukemia in chronic phase without the T315I mutation who have received ≥2 prior tyrosine kinase inhibitors (TKIs) in phase I and III clinical trials and in patients with the T315I mutation who have received ≥1 prior TKI in phase I. ASC4FIRST (NCT04971226) is a phase III, multicenter, open-label, randomized study of asciminib versus investigator-selected TKI in patients with newly diagnosed chronic myeloid leukemia in chronic phase. The primary end point is major molecular response at week 48. Secondary end points include responses at and by scheduled time points, safety, pharmacokinetics and patient-reported outcomes. Clinical Trial Registration: NCT04971226 (ClinicalTrials.gov).

• Authors: Jorge E Cortes, Andreas Hochhaus, Naoto Takahashi, Richard A Larson, Ghayas C Issa, Felice Bombaci, Nicholas Ramscar, Sophie Ifrah, Timothy P Hughes
• Journal: Future oncology (London, England) (Future Oncol) Vol. 18 Issue 38 Pg. 4161-4170 (Dec 2022) ISSN: 1744-8301 [Electronic] England
• PMID: 36524980 (Publication Type: Journal Article, Review)

Chemical References

• asciminib
• Protein Kinase Inhibitors
• Pyrazoles
• Fusion Proteins, bcr-abl
• Antineoplastic Agents

Topics

• Humans
• Protein Kinase Inhibitors (adverse effects)
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive (diagnosis, drug therapy, genetics)
• Pyrazoles (therapeutic use)
• Fusion Proteins, bcr-abl (genetics)
• Drug Resistance, Neoplasm (genetics)
• Antineoplastic Agents (adverse effects)
• Randomized Controlled Trials as Topic
• Multicenter Studies as Topic
• Clinical Trials, Phase III as Topic