Asciminib increases major molecular response rate in CML subset
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A randomized phase 3 trial designed to evaluate asciminib as treatment for certain patients with chronic myeloid leukemia met its primary endpoint, according to the agent’s manufacturer.
Asciminib (ABL001, Novartis) — an investigational therapy that targets the ABL myristoyl pocket (STAMP) — received fast track designation from the FDA.
The multicenter, open-label ASCEMBL trial compared asciminib with bosutinib (Bosulif, Pfizer) for adults with Philadelphia chromosome-positive CML in chronic phase who underwent prior treatment with at least two tyrosine kinase inhibitors. Patients who failed or were intolerant to the most recently administered TKI were eligible for the study.
Results showed a statistically significant improvement in major molecular response at 24 weeks — the study’s primary endpoint — among patients assigned asciminib.
Complete results of the trial will be shared with regulatory authorities and submitted for presentation at a medical meeting.
“Our ability to treat patients with TKIs changed CML care forever. However, the risk [for] disease progression is a reality for many patients — especially those who experience resistance to sequential TKI therapy or those who cannot adhere to treatment due to the daily impact of intolerable side effects,” John Tsai, MD, head of global drug development and chief medical officer for Novartis, said in a company-issued press release. “These results with asciminib are a testament to our commitment to further transform CML care — this time through STAMP inhibition, by exploiting a natural regulatory mechanism of the ABL kinase.”
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