Novartis presented new 96-week results from the Phase III ASC4FIRST trial of Scemblix® (asciminib) in first-line Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition.
The data reinforce the potential of Scemblix as a treatment option for patients with CML-CP. Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis, stated the company's commitment to prioritizing research in areas of greatest medical need and focusing on earlier stages of disease to change the treatment paradigm for people who require additional treatment options.
ASC4FIRST Trial
The ASC4FIRST trial is a Phase III study evaluating the efficacy and safety of asciminib compared to investigator-selected tyrosine kinase inhibitors (IS TKI) in newly diagnosed CML-CP patients. The longer-term 96-week results build upon the 48-week data that led to recent FDA approval.
Abstract #475 highlights that asciminib demonstrates favorable safety and tolerability compared with each investigator-selected tyrosine kinase inhibitor (IS TKI) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) in the pivotal Phase 3 ASC4FIRST study.
ASC2ESCALATE Trial
Interim results from the Phase 2 ASC2ESCALATE trial, Abstract #479, showcase the efficacy and safety of asciminib in chronic myeloid leukemia in chronic phase (CML-CP) in the cohort of patients (Pts) after 1 prior tyrosine kinase inhibitor (TKI).
ASC4OPT Study
Primary analysis from the ASC4OPT Study, Abstract #4526, indicates that asciminib shows high efficacy and favorable tolerability at 80 mg once daily and 40 mg twice daily in patients with chronic phase chronic myelogenous leukemia previously treated with 2 or more tyrosine kinase inhibitors.
