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RUBY Part 1 Trial Design

Learn more about the patient population studied in RUBY Part 1.

IN ALL-COMERS WITH PRIMARY ADVANCED OR RECURRENT EC

At 3+ Years, JEMPERLI + CP Has the Longest Median Follow-up for an Immunotherapy Combination to Date1-6*

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*The median duration of follow-up, defined as time from randomisation to data cutoff, was 37.2 months (cutoff date 22 September 2023).6
Randomisation was stratified by MMR/MSI status, prior external pelvic radiotherapy, and disease status (recurrent, primary Stage III, or primary Stage IV).1
Treatment continued for up to 3 years or until unacceptable toxicity, disease progression, or investigator decision.1
§PFS assessed by the investigator according to RECIST v1.1.1

AUC=area under the curve; CP=carboplatin + paclitaxel; dMMR=mismatch repair deficient; DOR=duration of response; EC=endometrial cancer; IV=intravenous; MMR=mismatch repair; MMRp=mismatch repair proficient; MSl=microsatellite instability; MSI-H=microsatellite instability-high; MSS=microsatellite stable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; Q3W=every 3 weeks; Q6W=every 6 weeks; RECIST v1.1=Response Evaluation Criteria in Solid Tumours v1.1.

IN PRIMARY ADVANCED OR RECURRENT EC

RUBY Part 1 Included Patients With Broad Disease Characteristics1,7

Primary FIGO Stage III or Stage IV disease, including patients with more aggressive histologies such as carcinosarcoma and serous adenocarcinoma1,7-9

Measurable Disease Measurable or Non-Measurable Disease1
Stage IIIA-IIIC1 Stage IIIC1 patients with carcinosarcoma, clear cell, serous, or mixed histology (≥10% carcinosarcoma, clear cell, or serous histology)
Stage IIIC2 or IV

First recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, including those1:

  • Naïve to systemic anticancer therapy
  • Who had received prior neoadjuvant/adjuvant systemic anticancer therapy and who had a recurrence or disease progression ≥6 months after completing treatment (first recurrence)

All patients were anti–PD-1/L1/L2 naïve.10

Prior radiation was not permitted within 21 days of study treatment excluding palliative radiotherapy, which was permitted within up to 1 week of study treatment.1

Measurable or evaluable by RECIST v1.1.1

FIGO=International Federation of Gynaecology and Obstetrics; PD-1=programmed death receptor 1; PD-L1/L2=programmed death ligand 1/2.

IN PRIMARY ADVANCED OR RECURRENT EC

RUBY Part 1 (N=494) Included Patients With Aggressive Histologies1,7-9

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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

  1. Jemperli (dostarlimab) SmPC (2026). Available at www.medicines.ie (accessed April 2026).
  2. Eskander RN, et al. N Engl J Med. 2023;388(23):2159-2170.
  3. Westin SN, et al; on behalf of the DUO-E Investigators. J Clin Oncol.2023;42(3):283-299.
  4. Keytruda (pembrolizumab) SmPC (2026). Available at www.medicines.ie (accessed April 2026)
  5. Imfinzi (durvalumab) SmPC (2026). Available at www.medicines.ie (accessed April 2026).
  6. Powell MA, et al. Ann Oncol. 2024;35(8):728-738.
  7. Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
  8. Bogani G, et al. Int J Gynecol Cancer. 2023;33(2):147-174.
  9. Clarke MA, et al. J Clin Oncol. 2019;37(22):1895-1908.
  10. ClinicalTrials.gov. Accessed April 2026. https://clinicaltrials.gov/study/NCT03981796

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-250007 | April 2026