Consistent Safety Profile With Over 2 Years of Efficacy Follow-up1-3
- The safety profile of dostarlimab has been evaluated in 241 patients with primary advanced or recurrent endometrial cancer who received dostarlimab in combination with carboplatin and paclitaxel in the RUBY study1
- 5.0% of patients permanently discontinued JEMPERLI due to adverse reactions1
- The most common adverse reactions (>10%) were rash (22.8%), rash maculopapular (14.1%), hypothyroidism (14.1%), alanine aminotransferase increased (12.9%), aspartate aminotransferase increased (12.0%), pyrexia (12.0%), and dry skin (10.4%)1
- Adverse reactions were serious in 5.8% of patients; most serious adverse reactions were immune-related adverse reactions1
The safety profile of JEMPERLI + CP was generally consistent with the safety profiles of the individual regimens1,2
Adverse Reactions in Patients With Primary Advanced or Recurrent Endometrial Cancer in the RUBY Study, Associated With JEMPERLI3
An adverse reaction is any adverse event or experience related to a medicine for which a reasonable causal relationship with the medicine's use is suspected.4
*One patient each from an ongoing blinded trial of dostarlimab in combination (N=760) reported myocarditis, myasthenic syndrome, immune-mediated gastritis, and vasculitis gastrointestinal; estimated frequency category.3
†Two patients in an ongoing trial of dostarlimab in combination (N=266) reported systemic inflammatory response syndrome, myositis.3
CP=carboplatin + paclitaxel.
Find Out More
RUBY Trial Results
JEMPERLI Dosing and Administration
JEMPERLI Support and Resources
JEMPERLI Is Indicated
- JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
- JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.
Dosage and method of administration
Method of administration: Administer by intravenous infusion using an intravenous infusion pump over 30 minutes.
JEMPERLI in combination with carboplatin and paclitaxel: The recommended dose is 500 mg dostarlimab every 3 weeks in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles followed by 1000 mg dostarlimab as monotherapy every 6 weeks for all cycles thereafter.
JEMPERLI monotherapy: The recommended dose as monotherapy is 500 mg dostarlimab every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter.
Adverse Events
- Very common (≥ 1/10): Anaemia, hypothyroidism, diarrhoea, nausea, vomiting, rash, pruritus, dry skin, arthralgia, pyrexia, increased transaminases.
- Common (≥ 1/100, < 1/10): Hyperthyroidism, pneumonitis, colitis, pancreatitis, gastritis, hepatitis, myalgia, chills, infusion- related reaction.
- Uncommon (≥ 1/1,000, < 1/100): Thyroiditis, hypophysitis, adrenal insufficiency, type 1 diabetes mellitus, diabetic ketoacidosis, encephalitis, myasthenia gravis, myasthenic syndrome, Guillain-Barré syndrome, uveitis, myocarditis, oesophagitis, immune-mediated gastritis, gastrointestinal vasculitis, immune-mediated arthritis, polymyalgia rheumatica, immune-mediated myositis, nephritis, systemic inflammatory response syndrome.
Precautions & relevant contraindications
- Hypersensitivity to dostarlimab or to any of the excipients. Breast-feeding
- Early identification and management of immune-related adverse reactions are essential to ensure safe use of dostarlimab. Patients should be monitored for symptoms and signs of immune-related adverse reactions. Haematological and clinical chemistries should be evaluated at baseline and periodically during treatment.
- All prescribers should provide the patient with the Patient Card and explain what to do should they experience any symptom of immune-related adverse reactions.
References
- JEMPERLI Summary of Product Characteristics. GSK. 2025.
- Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
- Data on file. GSK.
- EUPATI Open Classroom. Accessed December 11, 2023.
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie.
Adverse events should also be reported to GlaxoSmithKline on 1800 244 255 'or via online form' and include link to reporting form https://gsk.public.reportum.com/.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.
PM-IE-DST-WCNT-250003 | August 2025