Breakthrough progress in the treatment of Ph-positive chronic myelogenous leukemia with Aceminib

Asciminib (trade name Scemblix) has made breakthrough progress in the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML)

Aximini has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), recognizing its efficacy and safety in the treatment of adult patients with newly diagnosed chronic phase Ph+ CML. This designation is based on positive data from the phase III ASC4FIRST study, which showed that compared with standard treatment, tyrosine kinase Compared with inhibitors (TKI), aceminib achieved a superior molecular response rate at 48 weeks, and its safety and tolerability were better.

Aximinib is the first and only specific target inhibitor (STAMP) that acts on the ABL acyl pocket. This unique mechanism of action enables it to provide a new treatment option for patients who have received two or more TKI treatments and have poor efficacy or poor tolerability. It blocks the growth and spread of leukemia cells more precisely by targeting the acyl pocket of the ABL protein.

In clinical trials, patients treated with aceminib had higher rates of molecular response at 24 weeks compared with control drugs. For example, in a comparative study with bosertinib, aximinib-treated patients had more than twice the molecular response rate at 24 weeks compared with bosertinib. In addition, with long-term follow-up, the efficacy of aceminib has significantly improved, and the response rate has continued to increase.

The safety of aceminib has been confirmed by multiple clinical trials. Aceminib was associated with lower rates of adverse events and treatment discontinuation compared with standard-of-care TKIs. Common adverse reactions include upper respiratory tract infection, musculoskeletal pain, and abnormalities in some blood markers, but these are mild and controllable.