At the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California, David Andorsky, MD, Rocky Mountain Cancer Centers, Boulder, Colorado, shared the results of an interim analysis of the ASC in monotherapy 4 CML (AIM4CML) trial, which indicated that asciminib treatment continued to demonstrate molecular responses and tolerability among patients with chronic myeloid leukemia in the chronic phase (CML-CP), with responses deepening over time. 

Dr Andorsky noted that results were comparable between the once-daily and twice-daily dosage of asciminib and that safety and efficacy outcomes are consistent with prior trials. 

Transcript:

Good afternoon. My name is Dr. David Andorsky. I'm a medical oncologist [and] hematologist at the Rocky Mountain Cancer Center in Boulder, Colorado. I'm affiliated with the US Oncology Research Network. I sit on the Lymphoma Executive Committee, and I'm very happy to be here today to talk about a poster they have this evening looking at the use of asciminib, which is a new tyrosine kinase inhibitor (TKi) for the treatment of chronic myeloid leukemia in the chronic phase. 

This was a study looking at 2 different dosing levels of asciminib. Asciminib is a relatively new tyrosine kinase inhibitor. It has a unique mechanism of action compared to the other approved TKis. It binds to a different site on the BCR-ABL molecule. It's currently FDA-approved for use in [the] third line or beyond CML. This study was looking at use in that patient population using 2 different dosing regimens. 

One was 40 milligrams twice a day, and the other was 80 milligrams daily. There were 26 patients in each arm of the study. This was a randomized study, [and] we didn't see any real differences in either efficacy or safety between the 2 arms. Both arms had very good rates of major molecular response and de-molecular response, which is important in this patient population where they're getting the 3rd or subsequent line of therapy. In addition, we didn't see any real differences in the safety signal in terms of side effects experienced by patients, and very few patients in each arm discontinued therapy for lack of tolerance. 

In general, I think that once-daily dosing is more convenient for patients; it's easy to remember and it's correlated with better treatment adherence. It's good to have data indicating that the 80-milligram once-a-day dose is equally effective and safe [as] the 40-milligram twice-a-day dose. Thanks for your attention.

Source: 

Andorsky D, Issa GC, Broun ER, et al. Asciminib (ASC) once-daily (QD) dosing demonstrates comparable tolerability and efficacy to twice-daily (BID) dosing: Results from the ASC in monotherapy 4 CML (AIM4CML) study in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) Presented at the ASH 65th Annual Meeting & Exposition; December 9-12 2023; San Diego, California. Abstract 2406