Trial Outcomes & Findings for Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) (NCT NCT03578367)

Last Updated: 2025-11-10

Results Overview

Percentage of participants still treated with the randomized treatment at 48 weeks and are in MR4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all participants in the asciminib add-on arms vs imatinib arm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

104 participants

Primary outcome timeframe

at Week 48

Results posted on

2025-11-10

Participant Flow

All the participants were enrolled at 29 sites.

A total of 84 participants were planned to be randomized to arms 1 to 4.

Participant milestones

Participant milestones
Measure	Asciminib 40mg QD + Imatinib 400mg QD Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD Imatinib 400 mg taken once daily	Nilotinib 300mg BID Nilotinib 300 mg taken twice daily
Overall Study STARTED	21	21	21	21
Overall Study Treated	21	21	20	21
Overall Study Discontinued From Treatment	3	5	15	8
Overall Study Entered Safety Follow-up	0	2	1	6
Overall Study Discontinued Safety Follow-up	0	1	1	5
Overall Study COMPLETED	18	16	5	13
Overall Study NOT COMPLETED	3	5	16	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Asciminib 40mg QD + Imatinib 400mg QD Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD Imatinib 400 mg taken once daily	Nilotinib 300mg BID Nilotinib 300 mg taken twice daily
Overall Study Adverse Event	0	3	0	5
Overall Study Withdrawal by Subject	2	2	1	3
Overall Study Physician Decision	0	0	14	0
Overall Study Death	1	0	0	0
Overall Study Not treated	0	0	1	0

Baseline Characteristics

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asciminib 40mg QD + Imatinib 400mg QD n=21 Participants Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD n=21 Participants Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD n=21 Participants Imatinib 400 mg taken once daily	Nilotinib 300mg BID n=21 Participants Nilotinib 300 mg taken twice daily	Total n=84 Participants Total of all reporting groups
Age, Continuous	47.4 years STANDARD_DEVIATION 16.87 • n=5 Participants	43.7 years STANDARD_DEVIATION 15.72 • n=20 Participants	51.0 years STANDARD_DEVIATION 15.46 • n=40 Participants	44.4 years STANDARD_DEVIATION 13.12 • n=28 Participants	46.6 years STANDARD_DEVIATION 15.36 • n=46 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=20 Participants	5 Participants n=40 Participants	6 Participants n=28 Participants	24 Participants n=46 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=20 Participants	16 Participants n=40 Participants	15 Participants n=28 Participants	60 Participants n=46 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	15 Participants n=20 Participants	19 Participants n=40 Participants	16 Participants n=28 Participants	67 Participants n=46 Participants
Race/Ethnicity, Customized Chinese	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=28 Participants	1 Participants n=46 Participants
Race/Ethnicity, Customized Indian	0 Participants n=5 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants	1 Participants n=46 Participants
Race/Ethnicity, Customized Korean	1 Participants n=5 Participants	2 Participants n=20 Participants	1 Participants n=40 Participants	1 Participants n=28 Participants	5 Participants n=46 Participants
Race/Ethnicity, Customized Missing Asian	3 Participants n=5 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	2 Participants n=28 Participants	6 Participants n=46 Participants
Race/Ethnicity, Customized Missing - Overall	0 Participants n=5 Participants	2 Participants n=20 Participants	1 Participants n=40 Participants	1 Participants n=28 Participants	4 Participants n=46 Participants

PRIMARY outcome

Timeframe: at Week 48

Population: Full analysis set (FAS): The Full Analysis Set comprised all participants to whom study treatment has been assigned by randomization.

Outcome measures

Outcome measures
Measure	Asciminib 40mg QD + Imatinib 400mg QD n=21 Participants Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD n=21 Participants Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD n=21 Participants Imatinib 400 mg taken once daily	Nilotinib 300mg BID Nilotinib 300 mg taken twice daily
Molecular Response (MR)^4.5 Rate at 48 Weeks	19.0 Percentage of participants Interval 6.8 to 38.4	28.6 Percentage of participants Interval 13.2 to 48.7	0.0 Percentage of participants Interval 0.0 to 13.3	—

SECONDARY outcome

Timeframe: at Week 48

Population: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.

Percentage of participants in MR\^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks in asciminib add-on arms vs nilotinib arm.

Outcome measures

Outcome measures
Measure	Asciminib 40mg QD + Imatinib 400mg QD n=21 Participants Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD n=21 Participants Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD n=21 Participants Imatinib 400 mg taken once daily	Nilotinib 300mg BID Nilotinib 300 mg taken twice daily
Rate of MR^4.5 at 48 Weeks	19.0 Percentage of participants Interval 6.8 to 38.4	28.6 Percentage of participants Interval 13.2 to 48.7	4.8 Percentage of participants Interval 0.2 to 20.7	—

SECONDARY outcome

Timeframe: by 48 weeks

Population: FAS: The FAS comprised all participants to whom study treatment has been assigned by randomization.

Best observed MR\^4.5 rate (BCR-ABL1 ratio of ≤ 0.0032%) up to 48 weeks. This includes the percentage of participants who achieved MR 4.5 anytime up to 48 weeks.

Outcome measures

Outcome measures
Measure	Asciminib 40mg QD + Imatinib 400mg QD n=21 Participants Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD n=21 Participants Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD n=21 Participants Imatinib 400 mg taken once daily	Nilotinib 300mg BID n=21 Participants Nilotinib 300 mg taken twice daily
Rate of MR^4.5 by 48 Weeks	19.0 Percentage of participants Interval 6.8 to 38.4	28.6 Percentage of participants Interval 13.2 to 48.7	0 Percentage of participants Interval 0.0 to 13.3	14.3 Percentage of participants Interval 4.0 to 32.9

SECONDARY outcome

Timeframe: at 96 weeks

Percentage of participants with MR\^4.5 rate (BCR-ABL1 ratio of ≤ 0.0032%) at 96 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: by 96 weeks

Best observed MR4.5 rate (BCR-ABL1 ratio of ≤ 0.0032%) up to 96 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 96 weeks

Percentage of participants who are in MR\^4.5 at 48 weeks and 96 weeks and who have no loss of MR\^4.5 in between those 2 time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96/48 weeks after the last rand./enrolled (asciminib 80mg cohort) participant received the first study dose

Time to MR\^4.5 is the time from first dose to first MR\^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) computed only for participants who achieved MR\^4.5.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96/48 weeks after the last rand./enrolled (asciminib 80mg cohort) participant received the first study dose

Time from first MR\^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) until loss of MR\^4.5.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 96 weeks

The maximum (peak) observed drug concentration after dose administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 96 weeks

The time to reach maximum (peak) drug concentration after dose administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 96 weeks

Minimum drug concentration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 96 weeks

The AUC from time zero to the last measurable concentration sampling time (Tlast)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 96 weeks

The AUC calculated to the end of a dosing interval (tau) at steady-state

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 48 weeks

The percentage of participants on asciminib 80mg QD with MR\^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

The maximum (peak) observed drug concentration after dose administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

The time to reach maximum (peak) drug concentration after dose administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Minimum drug concentration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

The AUC from time zero to the last measurable concentration sampling time (Tlast)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

The AUC calculated to the end of a dosing interval (tau) at steady-state

Outcome measures

Outcome data not reported

Adverse Events

Nilotinib 300mg BID

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Asciminib 40mg QD + Imatinib 400mg QD

Serious events: 3 serious events

Other events: 19 other events

Deaths: 1 deaths

Asciminib 60mg QD + Imatinib 400mg QD

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Imatinib 400mg QD

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nilotinib 300mg BID n=21 participants at risk Nilotinib 300 mg taken twice daily	Asciminib 40mg QD + Imatinib 400mg QD n=21 participants at risk Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily	Asciminib 60mg QD + Imatinib 400mg QD n=21 participants at risk Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily	Imatinib 400mg QD n=20 participants at risk Imatinib 400 mg taken once daily
Cardiac disorders Cardiac arrest	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Appendiceal mucocoele	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Ileus	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis acute	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations COVID-19	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Investigations Lipase increased	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.
Nervous system disorders Dizziness	4.8% 1/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/21 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.	0.00% 0/20 • AEs & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 160 weeks for asciminib 40 mg + imatinib, 148 weeks for asciminib 60 mg + imatinib, 142 weeks for imatinib and 146 weeks for nilotinib. Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Adverse events were analyzed in the Safety analysis set, which comprises all patients who received at least one dose of study treatment.

Other adverse events

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