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JEMPERLI Dosing and Administration
JEMPERLI was permanently discontinued due to adverse reactions in 12 (5.0%) patients; most were immune-related events.1
In patients with primary advanced or recurrent EC receiving JEMPERLI + CP (N=241), the most common adverse reactions (≥10%) were rash (23.2%), rash maculopapular (14.5%), hypothyroidism (14.5%), pyrexia (12.9%), alanine aminotransferase increased (12.9%), aspartate aminotransferase increased (12.0%) and dry skin (10.0%).1
Adverse reactions were serious in 5.8% of patients. The most frequent (>1%) serious adverse reaction was pyrexia (2.9%).1
The most frequent (>10%) immune-related adverse reaction (irAR) was hypothyroidism (12.0%), with maculopapular rash (1.2%) the most frequent (>1%) irAR leading to treatment discontinuation.1
Early identification and management of irARs are essential to ensure safe use of PD-1/PD-L1 blocking antibodies.1
Patients should be monitored for signs and symptoms of immune- and infusion-related adverse reactions. Haematological and clinical chemistries, including liver, kidney, and thyroid function tests, should be evaluated at baseline and periodically during treatment.1
Based on the severity and type of irARs, treatment with JEMPERLI should be withheld or permanently discontinued and appropriate treatment administered.1
CP=carboplatin + paclitaxel; EC=endometrial cancer; PD-1=programmed death receptor 1; PD-L1=programmed death ligand 1.
Treatment-emergent adverse events (TEAEs) >30% in either arm in RUBY Part 1
Most common undesirable events which occurred or worsened once treatment was started in RUBY Part 12
| Adverse Event | Jemperli + CP (N=241) | Placebo + CP (N=246) |
|---|---|---|
| no. of patients (%) | no. of patients (%) | |
| Nausea | 131 (54.4%) | 114 (46.3%) |
| Alopecia | 130 (53.9%) | 123 (50.0%) |
| Fatigue | 126 (52.3%) | 135 (54.9%) |
| Neuropathy, peripheral | 106 (44.0%) | 103 (41.9%) |
| Anaemia | 91 (37.8%) | 105 (42.7%) |
| Arthralgia | 90 (37.3%) | 87 (35.4%) |
| Constipation | 84 (34.9%) | 89 (36.2%) |
| Diarrhoea | 76 (31.5%) | 72 (29.3%) |
AEs were assessed during the active treatment period and 90-day safety follow-up period or until the start of another anticancer therapy.3
IN RUBY PART 1
The 5 Most Common Grade ≥3 TRAEs Were Observed During the First 3-6 Months4
Time to onset for most common Grade ≥3 TRAEs
Patients received CP in combination with JEMPERLI during the first ~4 months of RUBY Part 1 (Q3W for 6 cycles).1
An adverse event (AE) is any untoward (not favourable) medical occurrence in a patient, or a clinical trial participant receiving a medicine, and which does not necessarily have a causal relationship with this treatment. An adverse reaction is any AE or experience related to a medicine for which a reasonable causal relationship with the medicine's use is suspected.5
A treatment-emergent adverse event (TEAE) is an adverse event that occurs or worsens after treatment has started, through 90 days after the last dose of study treatment.3,5 A treatment-related adverse event (TRAE) is an AE that was classified by study investigators as related to treatment.6
Find Out More
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.
- 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.
References
- Jemperli (dostarlimab) SmPC (2026). Available at www.medicines.ie (accessed April 2026).
- Powell MA, et al. Ann Oncol. 2024;35(8):728-738.
- Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
- Lokich E, et al. American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. Presented 31 May 2024.
- EUPATI Open Classroom. Glossary. Utrecht (NL): EUPATI. Accessed 10 December 2024. https://toolbox.eupati.eu/glossary/
- Auranen A, et al. Ther Adv Med Oncol. 2024;16:1-17.
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: 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 | May 2026
