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Safety outcomes for JEMPERLI from the GARNET trial
In recurrent/advanced post-platinum dMMR/MSI-H EC
JEMPERLI Demonstrated Manageable Safety Across Dose Transition1,2
Most adverse reactions were Grade 1 or 2 and manageable1,3
aIncludes anaemia, autoimmune haemolytic anaemia.
blncludes hypothyroidism, autoimmune hypothyroidism.
cIncludes thyroiditis, autoimmune thyroiditis.
dlncludes hypophysitis, lymphocytic hypophysitis.
eIncludes uveitis, iridocyclitis.
flncludes pneumonitis, interstitial lung disease, immune-mediated lung disease.
glncludes pneumonitis and interstitial lung disease.
hlncludes colitis, enterocolitis, and immune-mediated enterocolitis (monotherapy pool), and enteritis reported from ongoing blinded trial of dostarlimab in combination; estimated frequency category.
iIncludes colitis and immune-mediated enterocolitis (monotherapy pool), and enteritis reported from ongoing blinded trial of dostarlimab in combination; estimated frequency category.
jlncludes pancreatitis and pancreatitis acute.
klncludes gastritis (monotherapy pool), and immune-mediated gastritis and vasculitis gastrointestinal reported from ongoing blinded trial of dostarlimab in combination; estimated frequency category.
llncludes hepatitis, autoimmune hepatitis, and hepatic cytolysis.
mlncludes rash, rash maculo-papular, erythema, rash macular, rash pruritic, rash erythematous, rash papular, erythema multiforme, skin toxicity, drug eruption, toxic skin eruption, exfoliative rash, and pemphigoid.
nIncludes rash, rash maculo-papular, and drug eruption.
oIncludes myositis reported in an ongoing trial of dostarlimab in combination, and immune-mediated myositis (monotherapy pool); estimated frequency category.
plncludes nephritis and tubulointerstitial nephritis.
qlncludes transaminases increased, alanine aminotransferases increased, aspartate aminotransferases increased, and hypertransaminasaemia.
rIncludes alanine aminotransferase increased, aspartate aminotransferase increased and transaminases increased.
sIncludes infusion-related reaction and hypersensitivity.
The Discontinuation Rate Due to Adverse Reactions Was Low at 6.3%, With a Median Follow-Up of 27.6 Months1
- Most common adverse reactions in at least 10% of patients were anaemia, diarrhoea, nausea, vomiting, arthralgia, pruritus, rash, pyrexia, aspartate aminotransferase increased, and hypothyroidism1
- Some additional uncommon adverse reactions in patients treated with dostarlimab, such as myasthenic syndrome, systemic inflammatory response syndrome, and myocarditis (including immune-mediated myocarditis), were reported from ongoing category trials of dostarlimab in combination, and the frequency is estimated1
- All patients recovered from infusion-related reactions1
- Treatment-related adverse events did not increase after Q3W-to-Q6W dose transition2
The safety of JEMPERLI has been evaluated in 605 patients with endometrial cancer or other advanced solid tumours who received JEMPERLI monotherapy in the GARNET study, including 153 patients with recurrent/advanced dMMR/MSI-H endometrial cancer. Patients received doses of 500 mg every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter.1
In recurrent/advanced post-platinum dMMR/MSI-H EC
A Low Incidence of Grade 3 irARs Supports the Manageable Safety Profile of JEMPERLI1
Immune-related adverse reactions (irARs) were generally manageable for JEMPERLI1*
- There was 1 reported incident of a Grade 4 event (immune-related pneumonitis)
*The majority of JEMPERLI treatment discontinuations and serious adverse reactions were due to immune-related events. The rate of discontinuation due to adverse reactions was 6.3%, and the rate of serious adverse reactions was 11.2%.1
Find Out More
GARNET Trial Results
JEMPERLI Dosing and Administration
JEMPERLI Support and Resources
JEMPERLI Is Indicated4
- in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
- as monotherapy for the treatment of adult patients with dMMR/ MSI‑H recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.
Jemperli Safety Information4
Contraindications:
Hypersensitivity to the active substance or to any of the excipients
Adverse reactions:
Dostarlimab monotherapy:
Very common: Anaemia, Hypothyroidism, Diarrhoea, nausea, vomiting, Rash, pruritus, Arthralgia, Pyrexia and Transaminases increased
Common: Hyperthyroidism, adrenal insufficiency, Pneumonitis, Colitis , pancreatitis, gastritis, Hepatitis, Myalgia, Chills and Infusion-related reaction
Dostarlimab in combination therapy:
Very common: Hypothyroidism, Rash, dry skin, Pyrexia, Alanine aminotransferase increased and aspartate aminotransferase increased
Common: Hyperthyroidism, adrenal insufficiency, Pneumonitis and Colitis
▼ This medicine is subjected to additional monitoring. This will allow quick identification of new safety information. You may help by reporting any side effects you may get.
References
- JEMPERLI Summary of Product Characteristics. GSK. 2023.
- Oaknin A et al. Poster 003911 presented at the European Society of Gynaecological Oncology (ESGO) 22nd European Congress of Gynaecological Oncology; October 23-25, 2021; Prague, Czech Republic.
- Data on file. GSK.
- Jemperli Local PI
For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
Gulf.ProductQualityComplaints@gsk.com
Department of Pharmacovigilance & Drug Information |
دائرة التيقظ و المعلومات الدوائية مركز سلامة الدواء وزارة الصحة, سلطنة عمان هاتف: 0096822357687 / 0096822357690 0096822358489 :فاكس pharma-vigil@moh.gov.om :البريد االكتروني www.moh.gov.om : الموقع االكتروني |
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February 2025 | PM-AE-DST-WCNT-250001
