ASC4FIRST Trial: Asciminib Continues to Demonstrate Favorable Tolerability Versus TKIs in CML

Asciminib continues to demonstrate favorable safety and tolerability compared to tyrosine kinase inhibitors (TKIs) in patients with chronic phase chronic myeloid leukemia (CML), according to an exploratory post-hoc analysis of the ASC4FIRST trial presented at the Twelfth Annual Meeting of the Society of Hematologic Oncology.

In the phase III ASC4FIRST trial, patients were pre-randomized to receive either asciminib (n=100), imatinib (n=99), or a second-generation (2G) TKI (n=102). Follow-up ranged from 13.7 months to 17.4 months.

The most common nonhematologic adverse event (AE) was diarrhea of any grade (asciminib 11% vs imatinib 26.3%; asciminib 20% vs 2G TKIs 25.5%), and the most common hematologic AE was anemia of any grade (asciminib 10% vs imatinib 26.3%; asciminib 13% vs 2G TKIs 22.5%).

The rates of treatment discontinuation from AEs were 6% with asciminib versus 11.1% with imatinib and 5% with asciminib versus 9.8% with 2G TKIs. Dose reductions or interruptions occurred less frequently with asciminib (39%) than imatinib (49.5%) and with asciminib (40%) than 2G TKIs (63.7%). The median duration of dose reduction was 38 days for asciminib versus 208 days for imatinib; it was 43 days for asciminib versus 84 days for 2G TKIs.

“These results further support asciminib’s markedly favorable tolerability [versus] current standard-of-care frontline TKIs,” the researchers concluded.

Reference

Issa GC, Larson RA, Hughes TP, et al. Tolerability of asciminib vs investigator-selected (IS) tyrosine kinase inhibitors (TKIs) in the phase 3 ASC4FIRST study in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP). Abstract #CML-345. Presented at the Twelfth Annual Meeting of the Society of Hematologic Oncology; Sept. 4-7, 2024; Houston, Texas.