RUBY Part 1 All-Comers Efficacy Data
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RUBY Part 1 Trial Design
Learn more about the patient population studied in RUBY Part 1.
*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.
Primary FIGO Stage III or Stage IV disease, including patients with more aggressive histologies such as carcinosarcoma and serous adenocarcinoma1,7-9
| Measurable Disease1¶ | 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:
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.
JEMPERLI is indicated
References
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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.
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PM-IE-DST-WCNT-250007 | April 2026