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SAFETY PROFILE



SAFETY PROFILE IN PATIENTS AFTER 2 TKIs
SAFETY PROFILE IN PATIENTS WITH THE T315I MUTATION


SAFETY PROFILE IN PATIENTS AFTER 2 TKIs


FOR ADULTS WITH PH+ CML-CP, PREVIOUSLY TREATED WITH ≥2 TKIS MORE PATIENTS WERE
ABLE TO STAY ON SCEMBLIX1



Discontinuation rate due to adverse reactions was more than 3 times lower with
SCEMBLIX vs bosutinib.1,2



 * 6% of patients on SCEMBLIX (n=10/156) required dose reduction due to adverse
   reactions vs 28% on bosutinib (n=21/76)1,3

 * 41% of patients on SCEMBLIX (n=64/156) required dose interruption due to
   adverse reactions vs 58% on bosutinib (n=44/76)1,3




WELL-ESTABLISHED TOLERABILITY PROFILE OVER TIME1



Serious adverse reactions occurred in 18% of patients who received SCEMBLIX.
Serious adverse reactions in ≥1% included cardiac failure congestive (1.9%),
pyrexia (1.9%), urinary tract infection (1.9%), headache (1.3%), and
thrombocytopenia (1.3%). Two patients (1.3%) had a fatal adverse reaction, one
each for mesenteric artery thrombosis and ischemic stroke.1 

ARs, adverse reactions; URTI, upper respiratory tract infection.

aURTI includes: nasopharyngitis, upper respiratory infection, rhinitis,
pharyngitis, respiratory tract infection, and pharyngotonsillitis.
bMusculoskeletal pain includes: pain in extremity, back pain, myalgia,
non-cardiac chest pain, neck pain, bone pain, spinal pain, arthritis,
musculoskeletal pain, and musculoskeletal chest pain.
cHeadache includes: headache and post-traumatic headache.
dFatigue includes: fatigue and asthenia.
eRash includes: rash, rash maculopapular, dermatitis acneiform, rash pustular,
eczema, dermatitis, skin exfoliation, dermatitis exfoliative generalized, rash
morbilliform, drug eruption, erythema multiform, and rash erythematous.
fHypertension includes: hypertension and hypertensive crisis.
gAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal
discomfort, abdominal pain lower, abdominal tenderness, and epigastric
discomfort.
hDiarrhea includes: diarrhea and colitis.

The discontinuation rate due to ARs was more than 3 times lower with SCEMBLIX vs
bosutinib at Week 96 (8% vs 26%, respectively).1,2





LABORATORY ABNORMALITIES



ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate
aminotransferase.

iThe denominator used to calculate the rate for SCEMBLIX and bosutinib varied
from 152 to 156 and 75 to 76, respectively, based on the number of patients with
a baseline value and at least 1 post-treatment value.

The SCEMBLIX safety and tolerability profile at Week 96 was consistent and
comparable overall to that of the Week 24 analyses, with no new or worsening
safety findings.2





EXPOSURE-ADJUSTED INCIDENCE RATES OF ADVERSE EVENTS WITH SCEMBLIX AND BOSUTINIB4



Limitation: Exposure-adjusted incidence rate (EAIR) analysis is utilized when
there is a difference in exposure between 2 arms or 2 studies. The
exposure-adjusted rates assume the probability that an adverse event will happen
is constant over time, which is not always true.

The median duration of exposure was 24 months (range: 0 to 46 months) for
patients receiving SCEMBLIX and 7 months (range: 0 to 43 months) for patients
receiving bosutinib.4

As a result of the higher treatment discontinuation rate in the bosutinib arm,
the duration of exposure to SCEMBLIX and bosutinib differed. Incidence per 100
PTY is a measurement that compares the adverse event incidence rates between the
2 groups (268.9 PTY vs 72.9 with SCEMBLIX and bosutinib, respectively) while
adjusting for this imbalance in duration.

Adverse events of special interest (AESIs) were the AEs that represent the group
of AEs with specific interest when patients are being treated with study drug.
These AEs were defined based on the class effects of other TKIs in the same
class, mechanism of action, and the current preclinical and clinical knowledge
of the study drug. The AESIs related to SCEMBLIX are: myelosuppression,
pancreatic toxicity, hypersensitivity, hepatotoxicity, hepatitis B reactivation,
reproductive toxicity, GI toxicity, phototoxicity, QTc prolongation, cardiac
failure, edema and fluid retention, ischemic heart disease and CNS conditions,
AOEs, and hemorrhage.

Dose reductions for SCEMBLIX: hypersensitivity 1 (0.6%). Dose reductions for
bosutinib: edema and fluid retention 1 (1.3%); GI toxicity 10 (13.2%),
hepatotoxicity 3 (3.9%); hypersensitivity 3 (3.9%).2

AEs, adverse events; AOEs, arterial occlusive events; CNS, central nervous
system; EAIRs, exposure-adjusted incidence rates; GI, gastrointestinal; PTY,
patient-treatment years.

jBased on the safety analysis set. Numbers represent counts of patients. Other
adverse events of special interest, such as hepatitis B virus reaction,
hepatotoxicity (clinical events), pancreatic toxicity (clinical events), and
phototoxicity, were not reported.4
kAdverse events of special interest are reported as grouped adverse reactions.4
lGI toxicity includes diarrhea, nausea, abdominal pain, vomiting, constipation,
noncardiac chest pain, abdominal pain upper, abdominal distension, abdominal
pain lower, abdominal tenderness, epigastric discomfort, flatulence, and
abdominal discomfort.2
mIncludes ARs related to laboratory value abnormalities.4
nIncludes the preferred terms rash, rash maculopapular, dermatitis acneiform,
periorbital edema, rash pustular, rhinitis allergic, urticaria, allergic
transfusion reaction, dermatitis, dermatitis allergic, dermatitis contact,
dermatitis exfoliative generalized, eczema, rash morbilliform, drug eruption,
erythema multiforme, eyelid edema, face edema, hand dermatitis,
hypersensitivity, and rash erythematous.4
oIncluded 2 events of maternal exposure during pregnancy (with a spontaneous
abortion reported in one case) with asciminib and 2 diagnoses (after informed
consent) of congenital cardiovascular anomaly that were not resolved—1 each with
asciminib and bosutinib.4


INCIDENCE OF FIRST-EVER ADVERSE EVENTS WITH SCEMBLIX AND BOSUTINIB2,4



Denominator is the number of subjects at the beginning of the interval who have
not yet experienced the event. A subject with multiple occurrences of an AE with
the same preferred term within the same time interval under one treatment is
counted only once in that time interval for that treatment.

Thrombocytopenia, Neutropenia, and Erythropenia are group terms.

View the SCEMBLIX patient profiles >



SAFETY PROFILE IN PATIENTS WITH THE T315I MUTATION


FOR ADULT PATIENTS WITH PH+ CML-CP WITH THE T315I MUTATION1



Serious adverse reactions occurred in 23% of patients who received SCEMBLIX.
Serious adverse reactions in >1% included abdominal pain (4.2%), vomiting
(4.2%), pneumonia (4.2%), musculoskeletal pain (2.1%), headache (2.1%),
hemorrhage (2.1%), constipation (2.1%), arrhythmia (2.1%), and pleural effusion
(2.1%).1

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate
aminotransferase; URTI, upper respiratory tract infection.
pMusculoskeletal pain includes: pain in extremity, back pain, myalgia,
musculoskeletal pain, non-cardiac chest pain, bone pain, arthritis, and
musculoskeletal chest pain.
qFatigue includes: fatigue and asthenia.
rRash includes: rash, rash maculopapular, dermatitis acneiform, eczema, rash
papular, skin exfoliation, and dyshidrotic eczema.
sHeadache includes: headache and migraine.
tAbdominal pain includes: abdominal pain and hepatic pain.
uHemorrhage includes: epistaxiz, ear hemorrhage, mouth hemorrhage,
postprocedural hemorrhage, skin hemorrhage, and vaginal hemorrhage.
vCough includes: cough and productive cough.
wHypertension includes: hypertension and hypertensive crisis.
xURTI includes: upper respiratory tract infection, nasopharyngitis, rhinitis,
and pharyngitis.
yThe denominator used to calculate the rate was 48 based on the number of
patients with a baseline value and at least one post-treatment value.

IMPORTANT SAFETY INFORMATION 

Myelosuppression

 * Thrombocytopenia, neutropenia, and anemia, including grade 3/4 reactions,
   have occurred in patients receiving SCEMBLIX

 * Perform complete blood counts every 2 weeks for the first 3 months of
   treatment and monthly thereafter or as clinically indicated. Monitor patients
   for signs and symptoms of myelosuppression...

INDICATIONS

SCEMBLIX is indicated for the treatment of adult patients with:

 * Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in
   chronic phase (CP), previously treated with 2 or more tyrosine kinase
   inhibitors (TKIs)

 * Ph+ CML in CP with the T315I mutation...

Click or scroll to see IMPORTANT SAFETY INFORMATION AND INDICATIONS
References: 1. Scemblix. Prescribing information. Novartis Pharmaceuticals Corp.
2. Data on file. CABL001A2301 clinical study report. Novartis Pharmaceuticals
Corp; 2022. 3. Data on file. CABL001A Week 96 SCS. Novartis Pharmaceuticals
Corp; 2022. 4. Hochhaus A, Réa D, Boquimpani C, et al. Leukemia.
2023;37(3):617-626.
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