Safety and tolerability profile

SAFETY PROFILE

For adults with newly diagnosed Ph+ CML-CP

Discontinuation data for SCEMBLIX and standard-of-care* TKIs^1,2

*Imatinib, nilotinib, dasatinib, and bosutinib.

At Week 48^1,2

Chart indicating the permanent discontinuation due to ARs (all-grade) at Week 48.

By Week 48, 90% of patients were still on treatment with SCEMBLIX vs 81% on IS-TKIs (all).

At Week 96³

Chart indicating permanent discontinuation due to adverse reactions (all-grade) at Week 96.

Dose reductions and interruptions due to ARs (all-grade)

Charts displaying dose reductions due to adverse reactions (all-grade) and dosage interruptions due to adverse reactions (all-grade) at Week 48.

Chart displaying dose reductions due to adverse reactions (all-grade) and dosage interruptions due to adverse reactions (all-grade) at Week 96.

Safety profile at Week 48²

Graph showing Adverse reactions (≥10% in patients with newly diagnosed PH+ CML-CP at the Week 48 analysis.

^aMusculoskeletal pain includes: musculoskeletal pain, myalgia, pain in extremity, back pain, noncardiac chest pain, bone pain, neck pain, musculoskeletal stiffness, musculoskeletal discomfort, musculoskeletal chest pain, arthritis, and spinal pain.²
^bRash includes: rash, rash maculo-papular, rash pustular, rash macular, dermatitis exfoliative, drug eruption, dermatitis acneiform, eczema, rash pruritic, and rash vesicular.²
^cFatigue includes: fatigue and asthenia.²
^dDiarrhea includes: diarrhea, colitis, and enteritis.²
^eAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and gastrointestinal pain.²
^fUpper respiratory tract infection includes: upper respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, and respiratory tract infection.²
^gDyslipidemia includes: dyslipidemia, hypertriglyceridemia, blood cholesterol increased, hypercholesterolemia, hyperlipidemia, and blood triglycerides increased.²
^hHeadache includes: headache and migraine.²

Serious adverse reactions occurred in 11% of patients who received SCEMBLIX. Serious adverse reactions in ≥1% included pancreatitis (1%) and musculoskeletal pain (1%).²

Laboratory abnormalities at Week 48²

Chart indicating the select laboratory abnormalities (≥20%) that worsened from baseline at the week 48 analysis.

CTCAE version 5.0.
^aThe denominator used to calculate the rate for SCEMBLIX and IS-TKIs (all) varied from 198 to 200 and 201, respectively, based on the number of patients with a baseline value and at least one posttreatment value.²
^bWorst postbaseline laboratory abnormalities based on normal ranges.²

Safety profile at Week 96³

Chart detailing adverse reactions (≥10%) in patients with newly diagnosed Ph+ CML-CP at the Week 96 analysis.

^aMusculoskeletal pain includes: musculoskeletal pain, myalgia, pain in extremity, back pain, non-cardiac chest pain, bone pain, neck pain, musculoskeletal stiffness, musculoskeletal discomfort, musculoskeletal chest pain, arthritis, and spinal pain.³
^bRash includes: rash, rash maculo-papular, rash pustular, rash macular, dermatitis exfoliative, drug eruption, dermatitis acneiform, eczema, rash pruritic, and rash vesicular.³
^cFatigue includes: fatigue and asthenia.³
^dDiarrhea includes: diarrhea, colitis, and enteritis.³
^eAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and gastrointestinal pain.³
^fUpper respiratory tract infection includes: upper respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, and respiratory tract infection.³
^gDyslipidemia includes: dyslipidemia, hypertriglyceridemia, blood cholesterol increased, hypercholesterolemia, hyperlipidemia, and blood triglycerides increased.³
^hHeadache contains: headache and migraine.³
ⁱHypertension contains: blood pressure increased, blood pressure systolic increased, diastolic hypertension, hypertension and hypertensive crisis.³

Serious adverse reactions occurred in 14.5% of patients who received SCEMBLIX. Serious adverse reactions in ≥1% included pancreatitis (1%), musculoskeletal pain (1%), and peripheral neuropathy (1%).³

Laboratory abnormalities at Week 96³

Chart detailing select lab abnormalities (≥20%) that worsened from baseline at Week 96 analysis.

CTCAE version 5.0

^aThe denominator used to calculate the rate for SCEMBLIX and IS TKIs varied from 198 to 200 and 201, respectively, based on the number of patients with a baseline value and at least one posttreatment value.³
^bWorst postbaseline laboratory abnormalities based on normal ranges.³

EXPANDED SAFETY PROFILE

Safety profile: Expanded by standard-of-care TKIs at Week 48^1,2

Chart indicating the adverse reactions (≥10%) in patients with newly diagnosed Ph+ CML-CP at the week 48 analysis.

^kMusculoskeletal pain includes: musculoskeletal pain, myalgia, pain in extremity, back pain, non-cardiac chest pain, bone pain, neck pain, musculoskeletal stiffness, musculoskeletal discomfort, musculoskeletal chest pain, arthritis, and spinal pain.²
^lRash includes: rash, rash maculo-papular, rash pustular, rash macular, dermatitis exfoliative, drug eruption, dermatitis acneiform, eczema, rash pruritic, and rash vesicular.²
^mFatigue includes: fatigue and asthenia.²
ⁿDiarrhea includes: diarrhea, colitis, and enteritis.²
^oAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and gastrointestinal pain.²
^pUpper respiratory tract infection includes: upper respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, and respiratory tract infection.²
^qDyslipidemia includes: dyslipidemia, hypertriglyceridemia, blood cholesterol increased, hypercholesterolemia, hyperlipidemia, and blood triglycerides increased.²
^rHeadache includes: headache and migraine.²

Grade ≥3 treatment-related ARs were experienced by 26% of patients who received SCEMBLIX, and 38% and 33% of patients receiving IS-TKIs (all) and IS-TKIs (imatinib), respectively.

Laboratory abnormalities: Expanded by standard-of-care TKIs at Week 48^1,2,5

Chart indicating select laboratory abnormalities (≥20%) that worsened from baseline at the Week 48 analysis.

CTCAE version 5.0.
^aThe denominator used to calculate the rate for SCEMBLIX and IS-TKIs varied from 198 to 200 and 201, respectively, based on the number of patients with a baseline value and at least one post-treatment value.²
^bWorst postbaseline laboratory abnormalities based on normal ranges.²

2G, 2nd generation; AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events; Ph+ CML-CP, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase; TKI, tyrosine kinase inhibitor.

View the SCEMBLIX Data in Later Lines page >

Safety and tolerability profile

Discontinuation data for SCEMBLIX and standard-of-care* TKIs^1,2

Dose reductions and interruptions due to ARs (all-grade)

Safety profile at Week 48²

Laboratory abnormalities at Week 48²

Safety profile at Week 96³

Laboratory abnormalities at Week 96³

Safety profile: Expanded by standard-of-care TKIs at Week 48^1,2

Laboratory abnormalities: Expanded by standard-of-care TKIs at Week 48^1,2,5

Important Safety Information

Indications

Safety and tolerability profile

Discontinuation data for SCEMBLIX and standard-of-care* TKIs1,2

Dose reductions and interruptions due to ARs (all-grade)

Safety profile at Week 482

Laboratory abnormalities at Week 482

Safety profile at Week 963

Laboratory abnormalities at Week 963

Safety profile: Expanded by standard-of-care TKIs at Week 481,2

Laboratory abnormalities: Expanded by standard-of-care TKIs at Week 481,2,5

Discontinuation data for SCEMBLIX and standard-of-care* TKIs^1,2

Safety profile at Week 48²

Laboratory abnormalities at Week 48²

Safety profile at Week 96³

Laboratory abnormalities at Week 96³

Safety profile: Expanded by standard-of-care TKIs at Week 48^1,2

Laboratory abnormalities: Expanded by standard-of-care TKIs at Week 48^1,2,5