Pivotal Clinical Trial
Philadelphia chromosome-positive CML-CP
PHILADELPHIA CHROMOSOME-POSITIVE CML, EMA
The pivotal trial assessed by the EMA was the open-label, randomized, phase III ASCEMBL study in which patients with Philadelphia chromosome-positive CML-CP (The effects table of asciminib for the treatment of adult patients with Philadelphia chromosome-positive CML-CP previously treated with 2 or more TKIs.Reference groups are (1) the ASCEMBL trial; (2) the X2101 study, asciminib 80 mg once a day; and (3) pooled data of the ASCEMBL trial and the X2101 study, asciminib all dosages. Duration of MMR at 24 and 72 weeks was defined as the percentage of patients maintaining MMR for at least the respective number of weeks.Abbreviations: MMR, major molecular response; CCyR, complete cytogenetic response; NE, not estimable.