Asciminib (Novartis) is a BCR-ABL-targeted tyrosine kinase inhibitor (TKI) in development by Novartis for Philadelphia chromosome-positive diseases such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia. Unlike the first- and second-generation TKIs currently approved for CML, which target the catalytic site of ABL, asciminib targets the myristoyl pocket of ABL, allowing it to be effective in patients previously treated with other TKIs. Furthermore, asciminib’s ability to bind to an alternative site may allow the drug to be used in combination with another TKI, an approach which could be effective against a broad range of secondary mutations.
As Gleevec (imatinib; Novartis) remains the standard of care for first-line CML patients, and Tasigna’s (nilotinib; Novartis) primary role has been restricted to second-line patients, Novartis will develop asciminib for the third-line setting in order to avoid sales cannibalization and to bolster its CML franchise following the generic incursion of Gleevec. Asciminib is being tested head-to-head versus Bosulif (bosutinib; Pfizer) in a pivotal Phase III trial. While the exclusion criteria of this trial may prevent asciminib’s use in patients with specific secondary mutations, the drug has the potential to be more effective in combination with another TKI, which could provide previously treated patients with secondary mutations with an important alternative treatment option.
LIST OF FIGURES
7 Figure 1: Asciminib for CML – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary of asciminib for CML
9 Figure 3: Datamonitor Healthcare’s drug assessment summary of asciminib for CML
LIST OF TABLES
5 Table 1: Asciminib drug profile
6 Table 2: Asciminib Phase III trial in CML
6 Table 3: Asciminib early-phase trial data in CML
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