Novartis has presented the clinical trial data of its STAMP inhibitor asciminib (ABL001) in patients with chronic myeloid leukemia.
The company has presented the Phase 3 ASCEMBL trial results in which asciminib has shown statistically significant superiority in major molecular response (MMR) versus bosutinib. ASCEMBL is a Phase 3, multicenter, open-label randomized study, comparing the efficacy of asciminib versus bosutinib in Philadelphia chromosome-positive chronic myeloid leukemia.
The drug is indicated in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs). Patients who failed after treatment with the recently administered TKI inhibitor were included in the trial.
Despite the availability of multiple treatment options for chronic myeloid leukemia, increased resistance and tolerance have been reported with sequential TKI inhibitors. Asciminib inhibits the ABL myristoyl pocket, thereby addressing the issue of resistance and intolerance.
Asciminib has received Fast Track designation from the US FDA.
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