Trial Outcomes & Findings for Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation (NCT NCT04666259)

Last Updated: 2025-10-16

Results Overview

Adverse events (AEs) and serious adverse events (SAEs) are summarized by cohort. Clinically significant findings for vitals, laboratory values and electrocardiogram (ECG) are reported as adverse events and or serious adverse events as determined by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

56 participants

Primary outcome timeframe

Baseline to up to 24 Weeks

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A 40 mg asciminib orally twice daily (BID)	Cohort B 80 mg asciminib orally once daily (QD)	Cohort C 200 mg asciminib orally twice daily (BID)
Treatment Phase STARTED	26	27	3
Treatment Phase Treated	25	27	3
Treatment Phase COMPLETED	12	20	0
Treatment Phase NOT COMPLETED	14	7	3
Safety Follow-up Phase STARTED	23	24	3
Safety Follow-up Phase COMPLETED	20	23	3
Safety Follow-up Phase NOT COMPLETED	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A 40 mg asciminib orally twice daily (BID)	Cohort B 80 mg asciminib orally once daily (QD)	Cohort C 200 mg asciminib orally twice daily (BID)
Treatment Phase Physician Decision	9	3	3
Treatment Phase Adverse Event	3	1	0
Treatment Phase Subject decision	1	2	0
Treatment Phase Progressive disease	0	1	0
Treatment Phase Enrolled but not treated and discontinued	1	0	0
Safety Follow-up Phase Physician Decision	2	0	0
Safety Follow-up Phase Subject decision	1	0	0
Safety Follow-up Phase Death	0	1	0

Baseline Characteristics

Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	19 Participants n=7 Participants	3 Participants n=5 Participants	39 Participants n=4 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	14 Participants n=7 Participants	0 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	3 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	22 Participants n=7 Participants	1 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to up to 24 Weeks

Population: Safety set for cohorts A and B

Outcome measures

Outcome measures
Measure	Cohort A n=25 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C 200 mg asciminib orally twice daily (BID)
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A and B up to 24 Weeks Adverse Events (AEs)	23 Participants	26 Participants	—
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A and B up to 24 Weeks Serious Adverse Events (SAEs)	1 Participants	3 Participants	—
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A and B up to 24 Weeks Fatal SAEs	0 Participants	1 Participants	—
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A and B up to 24 Weeks AEs leading to treatment discontinuation	2 Participants	1 Participants	—
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A and B up to 24 Weeks AEs leading to dose adjustment/interruption	7 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Baseline up to 48 weeks

Population: Safety set (SS): all participants all who received at least one dose of study medication

Adverse events (AEs) and serious adverse events (SAEs) were summarized by cohort. Clinically significant findings for vitals, laboratory values and electrocardiogram (ECG) were reported as adverse events and or serious adverse events as determined by the investigator.

Outcome measures

Outcome measures
Measure	Cohort A n=25 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 48 Adverse Events (AEs)	24 Participants	26 Participants	3 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 48 Serious Adverse Events (SAEs)	2 Participants	3 Participants	1 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 48 Fatal SAEs	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 48 AEs leading to treatment discontinuation	3 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 48 AEs leading to dose adjustment/interruption	7 Participants	10 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to 72 weeks

Population: Safety set (SS): all participants all who received at least one dose of study medication

Outcome measures

Outcome measures
Measure	Cohort A n=25 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 72 Adverse Events (AEs)	24 Participants	26 Participants	3 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 72 Serious Adverse Events (SAEs)	4 Participants	4 Participants	1 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 72 Fatal SAEs	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 72 AEs leading to treatment discontinuation	3 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A, B and C by Week 72 AEs leading to dose adjustment/interruption	8 Participants	11 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline to 12, 24, 48, 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

A complete hematologic response (CHR) is defined as all of the following present for ≥ 4 weeks: * White blood cell count (WBC) \<10 x 10\^9/L * Platelet count \<450 x 10\^9/L * Basophils \<5%, * No blasts and promyelocytes in peripheral blood * Myelocytes + metamyelocytes \< 5% in peripheral blood * No evidence of extramedullary disease, including spleen and liver The estimated cumulative incidence rates were presented.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Percentage of Patients Achieving Complete Hematologic Response (CHR) for Cohorts A, B and C 12 weeks	76.9 Percentage of participants Interval 56.4 to 91.0	92.6 Percentage of participants Interval 75.7 to 99.1	100 Percentage of participants Interval 29.2 to 100.0
Percentage of Patients Achieving Complete Hematologic Response (CHR) for Cohorts A, B and C 24 weeks	76.9 Percentage of participants Interval 56.4 to 91.0	92.6 Percentage of participants Interval 75.7 to 99.1	100 Percentage of participants Interval 29.2 to 100.0
Percentage of Patients Achieving Complete Hematologic Response (CHR) for Cohorts A, B and C 48 weeks	76.9 Percentage of participants Interval 56.4 to 91.0	92.6 Percentage of participants Interval 75.7 to 99.1	100 Percentage of participants Interval 29.2 to 100.0
Percentage of Patients Achieving Complete Hematologic Response (CHR) for Cohorts A, B and C 72 weeks	76.9 Percentage of participants Interval 56.4 to 91.0	92.6 Percentage of participants Interval 75.7 to 99.1	100 Percentage of participants Interval 29.2 to 100.0

SECONDARY outcome

Timeframe: Baseline up to 12, 24, 48, 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

The rate of major molecular response (MMR) by 12, 24, 48 and 72 weeks after the start of first study medication is defined as ≥ 3 log reduction of BCR-ABL (transcript from standardized baseline or ≤0.1% BCR-ABL/ABL % by international scale, measured by real-time quantitative polymerase chain reaction (RQ-PCR). BCR-ABL fusion gene is also called the Philadelphia chromosome. The estimated cumulative incidence rates were presented.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Percentage of Patients Achieving Major Molecular Response (MMR) for Cohorts A, B and C 72 weeks	50.0 Percentage of participants Interval 29.9 to 70.1	70.4 Percentage of participants Interval 49.8 to 86.3	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Major Molecular Response (MMR) for Cohorts A, B and C 12 weeks	38.5 Percentage of participants Interval 20.2 to 59.4	44.4 Percentage of participants Interval 25.5 to 64.7	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Major Molecular Response (MMR) for Cohorts A, B and C 24 weeks	42.3 Percentage of participants Interval 23.4 to 63.1	63.0 Percentage of participants Interval 42.4 to 80.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Major Molecular Response (MMR) for Cohorts A, B and C 48 weeks	46.2 Percentage of participants Interval 26.6 to 66.6	70.4 Percentage of participants Interval 49.8 to 86.3	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Baseline up to 12, 24, 48, 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

The rate of molecular response (MR2) by 12, 24, 48 and 72 weeks after the start of first study medication is defined as ≥ 2 log reduction of BCR-ABL (transcript from standardized baseline or ≤ 1% BCR-ABL/ABL % by international scale, measured by real-time quantitative polymerase chain reaction (RQ-PCR). BCR-ABL fusion gene is also called the Philadelphia chromosome. The estimated cumulative incidence rates were presented.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Percentage of Patients Achieving Molecular Response (MR2) for Cohorts A, B and C 12 weeks	53.8 Percentage of participants Interval 33.4 to 73.4	70.4 Percentage of participants Interval 49.8 to 86.3	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response (MR2) for Cohorts A, B and C 24 weeks	57.7 Percentage of participants Interval 36.9 to 76.7	85.2 Percentage of participants Interval 66.3 to 95.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response (MR2) for Cohorts A, B and C 48 weeks	61.5 Percentage of participants Interval 40.6 to 79.8	85.2 Percentage of participants Interval 66.3 to 95.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response (MR2) for Cohorts A, B and C 72 weeks	61.5 Percentage of participants Interval 10.6 to 79.8	85.2 Percentage of participants Interval 66.3 to 95.8	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Baseline up to 12, 24, 48, 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

The rate of molecular response (MR4) by 12, 24, 48 and 72 weeks after the start of first study medication is defined as ≥ 4 log reduction of BCR-ABL (transcript from standardized baseline or ≤ 0.01% BCR-ABL/ABL % by international scale, measured by real-time quantitative polymerase chain reaction (RQ-PCR). BCR-ABL fusion gene is also called the Philadelphia chromosome. The estimated cumulative incidence rates were presented.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Percentage of Patients Achieving Molecular Response 4 (MR4) for Cohorts A, B and C 12 weeks	30.8 Percentage of participants Interval 14.3 to 51.8	18.5 Percentage of participants Interval 6.3 to 38.1	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response 4 (MR4) for Cohorts A, B and C 24 weeks	30.8 Percentage of participants Interval 14.3 to 51.8	29.6 Percentage of participants Interval 13.8 to 50.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response 4 (MR4) for Cohorts A, B and C 48 weeks	38.5 Percentage of participants Interval 20.2 to 59.4	44.4 Percentage of participants Interval 25.5 to 64.7	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response 4 (MR4) for Cohorts A, B and C 72 weeks	38.5 Percentage of participants Interval 20.2 to 59.4	48.1 Percentage of participants Interval 28.7 to 68.1	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Baseline up to 12, 24, 48, 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

The rate of molecular response (MR4.5) by 12, 24, 48 and 72 weeks after the start of first study medication is defined as ≥ 4.5 log reduction of BCR-ABL (transcript from standardized baseline or ≤ 0.0032% BCR-ABL/ABL % by international scale, measured by real-time quantitative polymerase chain reaction (RQ-PCR). BCR-ABL fusion gene is also called the Philadelphia chromosome. The estimated cumulative incidence rates were presented.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Percentage of Patients Achieving Molecular Response 4.5 (MR4.5) for Cohorts A, B and C 12 weeks	23.1 Percentage of participants Interval 9.0 to 43.7	11.1 Percentage of participants Interval 2.4 to 29.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response 4.5 (MR4.5) for Cohorts A, B and C 24 weeks	26.9 Percentage of participants Interval 11.6 to 47.8	18.5 Percentage of participants Interval 6.3 to 38.1	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response 4.5 (MR4.5) for Cohorts A, B and C 48 weeks	30.8 Percentage of participants Interval 14.3 to 51.8	25.9 Percentage of participants Interval 11.1 to 46.3	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Patients Achieving Molecular Response 4.5 (MR4.5) for Cohorts A, B and C 72 weeks	30.8 Percentage of participants Interval 14.3 to 51.8	29.6 Percentage of participants Interval 13.8 to 50.2	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Baseline up to 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

Time to achieving a response level is defined as the time from the date of the first dose of study medication to the first documented achievement of each defined response level. Time to achieve a specific response level was analyzed using the Kaplan-Meier Product-Limit method. Patients who are known to be without achieving that response level were censored at the last adequate assessment.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Time to Achieve CHR, MR2, MMR, MR4, MR4.5 for Cohorts A, B and C CHR	11.1 weeks Interval 11.1 to 12.0	11.9 weeks Interval 11.1 to 12.1	11.1 weeks Interval 10.9 to NA = not estimable as there were not enough events
Time to Achieve CHR, MR2, MMR, MR4, MR4.5 for Cohorts A, B and C MMR	24.0 weeks Interval 4.1 to NA = not estimable as there were not enough events	22.9 weeks Interval 11.1 to 28.3	NA weeks NA = not estimable as there were not enough events
Time to Achieve CHR, MR2, MMR, MR4, MR4.5 for Cohorts A, B and C MR2	8.3 weeks Interval 4.0 to 47.0	4.3 weeks Interval 3.9 to 11.6	NA weeks NA = not estimable s there were not enough events
Time to Achieve CHR, MR2, MMR, MR4, MR4.5 for Cohorts A, B and C MR4	36.1 weeks Interval 11.1 to NA = not estimable as there were not enough events	58.6 weeks Interval 23.1 to NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events
Time to Achieve CHR, MR2, MMR, MR4, MR4.5 for Cohorts A, B and C MR4.5	NA weeks Interval 23.1 to NA = not estimable as there were not enough events	NA weeks Interval 48.1 to NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events

SECONDARY outcome

Timeframe: Baseline up 72 weeks

Population: All participants in the Full Analysis Set (FAS) who achieved a particular response. FAS: All participants to whom study medication had been assigned

Duration of Response (DOR) is the time from the date of the first documented molecular response level to the date of first documented loss of the response level or death due to any cause, whichever occurs first. DOR for each response level was analyzed using the Kaplan-Meier Product-Limit method. Participants continuing without that event were censored at the date of their last adequate response assessment.

Outcome measures

Outcome measures
Measure	Cohort A n=20 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=25 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Duration of CHR, MR2, MMR, MR4 and MR4.5 for Cohorts A, B and C MR 4.5	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events	—
Duration of CHR, MR2, MMR, MR4 and MR4.5 for Cohorts A, B and C CHR	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events
Duration of CHR, MR2, MMR, MR4 and MR4.5 for Cohorts A, B and C MMR	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events	—
Duration of CHR, MR2, MMR, MR4 and MR4.5 for Cohorts A, B and C MR2	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events	—
Duration of CHR, MR2, MMR, MR4 and MR4.5 for Cohorts A, B and C MR 4	NA weeks NA = not estimable as there were not enough events	NA weeks Interval 2.9 to NA = not estimable as there were not enough events	—

SECONDARY outcome

Timeframe: Baseline up to 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

Progression Free Survival (PFS) is defined as time from the first dose of study medication to disease progression to accelerated phase/blast crisis (AP/BC) or death due to any cause, whichever occurs first. PFS was analyzed using the Kaplan-Meier Product-Limit method. Subjects who did not progress were censored at the last adequate assessment.

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Progression Free Survival (PFS) for Cohorts A, B and C	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events

SECONDARY outcome

Timeframe: Baseline up to 72 weeks

Population: Full Analysis Set (FAS): All participants to whom study medication had been assigned

Overall Survival (OS) is defined as the time from the first dose of study medication to death due to any cause during study. If a patient was not known to have died, then OS was censored at the latest date the patient was known to be alive. OS was analyzed using the Kaplan-Meier Product-Limit method

Outcome measures

Outcome measures
Measure	Cohort A n=26 Participants 40 mg asciminib orally twice daily (BID)	Cohort B n=27 Participants 80 mg asciminib orally once daily (QD)	Cohort C n=3 Participants 200 mg asciminib orally twice daily (BID)
Overall Survival Overall Survival (OS) for Cohorts A, B and C	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events	NA weeks NA = not estimable as there were not enough events

Adverse Events

Cohort A

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Cohort B

Serious events: 4 serious events

Other events: 26 other events

Deaths: 2 deaths

Cohort C

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort A n=25 participants at risk 40 mg asciminib orally twice daily (BID)	Cohort B n=27 participants at risk 80 mg asciminib orally once daily (QD)	Cohort C n=3 participants at risk 200 mg asciminib orally twice daily (BID)
Cardiac disorders Acute coronary syndrome	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Cardiac disorders Myocardial infarction	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Gastrointestinal disorders Oesophageal perforation	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
General disorders Malaise	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	33.3% 1/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Infections and infestations Appendicitis	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Infections and infestations COVID-19 pneumonia	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Infections and infestations Pelvic infection	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Infections and infestations Sepsis	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Injury, poisoning and procedural complications Meniscus injury	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Nervous system disorders Brain stem infarction	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	4.0% 1/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/25 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	3.7% 1/27 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).	0.00% 0/3 • From Baseline to 30 days after last treatment (up to a maximum of approximately 85 weeks).