Novartis' Asciminib benefits for third or more time in chronic myelogenous leukemia

Asciminib (Asciminib) was developed as a fourth-generation tyrosine kinase inhibitor (TKI) and was approved for the treatment of adults with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CP-CML) in the chronic phase who have received two or more TKI treatments.

In the phase 3 study of ASCEMBL, aceminib demonstrated improved molecular and cytogenetic response rates (MMR and CCyR) compared with the second-generation TKI bosutinib (Bosulif) in patients 18 years and older with chronic phase chronic myelogenous leukemia. In this study, the molecular response rates (MMR) of Asiminib and Bosulif at week 24 were 25.5% and 13.2%, respectively, and the cytogenetic response rates (CCyR) at week 24 were 40.8% and 24.2%. Asiminibalso demonstrated its clinical utility in the MAIC study, which indirectly compared it with the third-generation TKI ponatinib (Iclusig). In this study, the MMRs of aciminib and Iclusig at 24 months were 34% and 23%, respectively, and the CCyRs at 12 months were 42% and 43%, respectively.

Based on these studies, the current NCCN guidelines recommendaceminib be classified as Category 2A for the treatment of chronic phase chronic myelogenous leukemia in patients who are resistant or intolerant to two or more prior TKIs. T315l and V299L mutations are the most common forms of BCR-ABL kinase domain mutations, and these mutations are known to cause resistance to TKIs. Patients who are resistant to TKls are more likely to fail treatment. By shortening treatment time, it is possible to increase the number of patients who can discontinue treatment early and reduce side effects, thereby reducing additional ancillary costs.