Cumulative rate of MMR

Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months

Month 12

Cumulative rate of MMR

The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period

Month 3, Month 6, Month 9, Month 18 and Month 24

Cumulative rate of deep molecular response (DMR): MR4 and MR4.5

Cumulative rate of MR4 is defined as at least one BCR::ABL1 transcript level ≤ 0.01% during the follow-up period; Cumulative MR4.5 is defined as at least one BCR::ABL1 transcript level ≤0.0032% during the follow-up period

Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24

Cumulative rate of complete cytogenetic response (CCyR)

Cumulative CCyR is defined as at least one cytogenetic examination showing 0 Ph+ cells during the follow-up period

Month 3, Month 6, and Month 12

Time to first MMR

Time to first MMR is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.1% during the follow-up period

24 month follow up period

Time to first MR4 and MR4.5

Time to first MR4 is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.01% during the follow-up period. Time to first MR4 is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.0032% during the follow-up period

24 month follow up period

Time to first complete cytogenetic response (CCyR)

Time to first CCyR is defined as the time interval from baseline to the first occurrence of CCyRduring the follow-up period

24 month follow up period

Early molecular response (EMR) rate at 3 months

Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3

Month 3

Complete hematologic response (CHR) rate

the proportion of patients achieving white blood cell count \< 10 × 109/L, platelet count \< 450 × 109/L, no immature myeloid cells in peripheral blood, peripheral blood basophil percentage \< 5%, absence of symptoms/signs of extramedullary involvement, and non-palpable spleen at M1, M2, and M3

Month 1, Month 2, and Month 3

Rate of decline in BCR::ABL1 transcript levels

indirectly calculated from BCR::ABL1 transcript levels at baseline, M1, M2, M3, M6, M9, and M12; determined by BCR::ABL1 halving time

Baseline, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12

Duration of MMR

Definition of duration: Duration = sum of "intervals"; Interval calculation method: the first visit at which a response is achieved (and previously unmeasured) within the interval is taken as the starting point, then evaluated sequentially in time order; the calculation stops upon encountering a visit that fails to meet the criterion; The duration is calculated as the time interval between the first and last visit at which the response was achieved; Missing visit data points during this period will be defaulted as achieving the response.

24 month follow up period

Duration of MR4 and MR4.5

24 month follow-up period

Event-Free survival (EFS) rate

Lack of efficacy: * Failure to achieve expected molecular response: failure to reach the molecular response milestones recommended by the ELN guidelines at prespecified time points; * Loss of molecular response: loss of confirmed MMR following achievement of MMR, or loss of CCyR. Disease progression: progression from the chronic phase to the accelerated phase or blast crisis. Death: fatal outcome due to any cause during the treatment period. Treatment discontinuation due to adverse events: permanent discontinuation caused by intolerable toxicity, serious adverse events, or other safety-related reasons associated with the study drug.

Month 12 and Month 24

Progression-free survival (PFS) rate

Month 12 and Month 24

Overall survival (OS) rate

Month 12 and Month 24

Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment

24 month follow-up period

Asciminib persistence rates

Month 6, Month 12, and Month 24

Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs

24 month follow-up period

Proportion of patients requiring concomitant medications due to AEs

24 month follow-up period

Change in the simplified CML quality of life questionnaire from baseline

Baseline, Month 12 and Month 24

Compliance following asciminib treatment

Medication possession ratio

24 month follow-up period

Concomitant medication use associated with AEs related to asciminib

24 month follow-up period

Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment

24 month follow-up period

Gene mutation rate associated with asciminib treatment

Gene mutation rate associated with asciminib treatment; types and proportions of positive gene mutations identified via genetic testing.

24 month follow-up period