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RUBY Trial Overview and Results

Learn more about the efficacy results of JEMPERLI▼ + carboplatin-paclitaxel (CP) in the dMMR/MSI-H subgroup of the RUBY trial.

See the RUBY efficacy results

The Primary Efficacy Outcome Measures in the Overall Population of the RUBY Trial Were PFS* and OS1

The primary efficacy outcome measure for the dMMR/MSI-H subgroup was PFS*

NA NA

Randomisation was stratified by MMR/MSI status, prior external pelvic radiotherapy, and disease status (recurrent, primary Stage III, or primary Stage IV).1

In the dMMR/MSI-H subgroup, key secondary efficacy outcome measures were ORR§ and DOR.2§

Efficacy was assessed in a subgroup of 118 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer.1

*Assessed by the investigator according to RECIST v1.1.1
†In RUBY, 494 patients underwent randomisation to each treatment arm. The safety profile was evaluated in the 241 patients with primary advanced or recurrent endometrial cancer who were randomised to JEMPERLI + CP.1,2
‡Treatment continued for up to 3 years or until unacceptable toxicity, disease progression, or investigator decision.1
§As assessed by blinded independent central review (BICR) and investigator assessment according to RECIST v1.1.2

AUC=area under the curve; CP=carboplatin + paclitaxel; dMMR=mismatch repair deficient; DOR=duration of response; IV=intravenous; MMR=mismatch repair; MSI=microsatellite instability; MSI-H=microsatellite instability-high; 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.

RUBY Trial Included Patients With Broad Disease Characteristics1

Primary FIGO Stage III or Stage IV endometrial cancer, including patients with more aggressive histologies1,3,4

Measurable Disease1*
 Measurable* or Non-Measurable Disease1
Stage IIIA to 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 those:

  • Naïve to systemic anticancer therapy1
  • Who had received prior neoadjuvant/adjuvant systemic anticancer therapy and who had a recurrence or progressive disease ≥6 months after completing treatment (first recurrence)1

All patients were anti-PD-1, PD-L1/L2 naïve.5
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=programmed death ligand 1; PD-L2=programmed death ligand 2.

The RUBY Trial Included dMMR/MSI-H Endometrial Cancer Patients With Diverse Disease Characteristics (n=118)1,2

Patient population Patient population

Progression-free survival results in the dMMR/MSI-H JEMPERLI + CP arm

Proven Efficacy With a 72% Reduction in the Risk of Progression or Death vs CP Alone1*†

Estimated probability of PFS in the dMMR/MSI subgroup (n=118)1,2‡

NA NA

Median PFS not reached with JEMPERLI + CP after >2 years of follow-up compared with 7.7 months (95% CI: 5.6-9.7) with CP alone1*

Hazard ratio for risk of progression or death with JEMPERLI + CP vs CP alone (HR=0.28, 95% Cl: 0.16-0.50†; P<0.001)1*

Median duration of follow up was 24.8 months in the dMMR/MSI-H population1

*One-sided P-value based on stratified log-rank test.1
†Based on stratified Cox regression model.1
‡By Kaplan-Meier method.2

Efficacy was evaluated in 118 patients.1
CI=confidence interval; HR=hazard ratio.

In the dMMR/MSI-H endometrial cancer subgroup

Overall Survival Results1

Estimated probability of OS in the dMMR/MSI-H subgroup (n=118)1,2*

RUBY overall survival in the dMMR/MSI-H subgroup Kaplan-Meier curve RUBY overall survival in the dMMR/MSI-H subgroup Kaplan-Meier curve
  • OS hazard ratio was 0.30 (95% Cl: 0.13-0.70)1†
  • Probability of OS at 2 years*: 83.3% OS rate with JEMPERLI + CP (95% Cl: 66.8-92.0) compared with 58.7% (95% Cl: 43.4-71.2) with CP alone2
  • >2 years of follow-up: Median duration of follow up was 24.8 months in the dMMR/MSI-H population1
  • The maturity rate of OS data in the dMMR/MSI-H subgroup was 26%. OS was a prespecified exploratory analysis in the dMMR/MSI-H subgroup and is not statistically significant since no hypothesis testing was performed2,6

Not statistically significant since no hypothesis testing was performed for OS in the dMMR/MSI-H population.1

*By Kaplan-Meier method.2

†Based on stratified Cox regression model.1

In the dMMR/MSI-H JEMPERLI + CP Arm

77.6% of Patients Responded to JEMPERLI + CP7

Objective Response Rate2*

RUBY objective response rate in the dMMR/MSI-H subgroup graph

>1 out of 3 Patients Who Responded to Treatment Achieved a Complete Response With JEMPERLI + CP (n=15/38)7

Chemotherapy alone
Patients on CP alone achieved a 69.0% (n=40) ORR (95% CI: 55.5%-80.5%) with 20.7% (n=12) CR and 48.3% (n=28) PR2

>2 years of follow-up
Median follow-up time was 24.8 months2

*Assessed by investigator according to RECIST v1.1.2

CR=complete response; PR=partial response.

In the dMMR/MSI-H JEMPERLI + CP Arm

62.1% of Patients Who Responded Were Estimated to Maintain a Response at 2 Years2*†‡7

Estimated probability of DOR in the dMMR/MSI-H subgroup (n=118)2*†‡

Ruby-duration-of-response-in-the-dmmr-msi-h-subgroup-kaplan-meier-curve

More than 4 times as many responders had a probability of continued response at 2 years with JEMPERLI + CP compared with CP alone2*†‡

Median DOR was not estimable (95% Cl: 10.1-NE) with 24.8 months median follow-up in the JEMPERLI + CP arm compared with 5.4 months (95% Cl: 3.9-8.1) with CP alone2†‡

*By Kaplan-Meier method.2
†Assessed by investigator according to RECIST v1.1.2
‡For patients with a partial or complete response.2

NE=not estimable.

  • See ≥1 year DOR

    In the dMMR/MSI-H JEMPERLI + CP Arm

    57.9% of Patients Who Responded Had DOR Lasting ≥1 Year2*†

    Patients in the dMMR/MSI-H subgroup with DOR ≥1 year2*†

    RUBY 1-year duration of response in the dMMR/MSI-H subgroup graph

    Over half of patients who responded to JEMPERLI + CP had a DOR of ≥1 year compared with 17.5% of patients who responded on CP alone2*†

    Median DOR was not estimable*† (95% Cl: 10.1-NE) in the JEMPERLI + CP arm after >2 years of follow-up compared with 5.4 months (95% Cl: 3.9-8.1) with CP alone2

    24.8 months median follow-up time2

    *Assessed by investigator according to RECIST v1.1.2
    †For patients with a partial or complete response.2

Find Out More

RUBY Safety Profile

See RUBY safety Profile

JEMPERLI Dosing and Administration

See Dosing and Administration

JEMPERLI Support and Resources

See 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.

References

  1. Jemperli (dostarlimab) Summary of product characteristics January 2025 https://www.medicines.ie/ Last accessed April 2025.
  2. Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
  3. Bogani G, et al. Int J Gynecol Cancer. 2023;33(2):147-174.
  4. Clarke MA, et al. J Clin Oncol. 2019;37(22):1895-1908.
  5. ClinicalTrials.gov. Accessed July 24, 2023. https://www.clinicaltrials.gov/study/NCT03981796?cond=NCT03981796
  6. Mirza MR, et al. Society of Gynecologic Oncology 2023 Annual Meeting on Women’s Cancer. Presented March 27, 2023.
  7. Supplementary material https://www.nejm.org/doi/suppl/10.1056/NEJMoa2216334/suppl_file
    /nejmoa2216334_appendix.pdf     Maurer W, Bretz F. Memory and other properties of multiple test procedures generated by entangled graphs. Stat Med. 2013;32:1739-53.

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.

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April 2025 | PM-IE-DST-WCNT-250007