WEDNESDAY, June 5, 2024 (HealthDay News) -- For patients with newly diagnosed chronic myeloid leukemia (CML), asciminib shows superior efficacy and a favorable safety profile compared with investigator-selected tyrosine kinase inhibitors (TKIs), according to a study published online May 31 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.
Andreas Hochhaus, Dr.Med., from Universitätsklinikum Jena and Comprehensive Cancer Center Central Germany, and colleagues randomly assigned patients with newly diagnosed CML to receive asciminib or an investigator-selected TKI (including imatinib and second-generation TKIs) in a 1:1 ratio (201 and 204 patients, respectively). Patients were followed for a median of 16.3 and 15.7 months in the asciminib and investigator-selected TKI groups, respectively.
The researchers found that at week 48, a major molecular response occurred in 67.7 and 49.0 percent of patients in the asciminib and investigator-selected TKI group, respectively; within the imatinib stratum, a major molecular response occurred in 69.3 and 40.2 percent of those in the asciminib and imatinib groups, respectively, while in the second-generation TKI stratum, the corresponding percentages were 66.0 and 57.8 percent with asciminib and TKIs. Compared with imatinib and second-generation TKIs, adverse events of grade 3 and higher and events leading to discontinuation of the trial regimen occurred less often with asciminib.
"Long-term follow-up is needed to further elucidate the benefit of asciminib as a treatment for newly diagnosed CML," the authors write. "Currently, after a median follow-up of almost 1.5 years, asciminib has had superior efficacy and favorable safety and side-effect profiles as compared with investigator-selected TKIs and with imatinib in patients with newly diagnosed CML."
Several authors disclosed ties to pharmaceutical companies, including Novartis, which manufactures asciminib and funded the study.
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