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RUBY Part 1 Trial Results

Learn more about the efficacy results of JEMPERLI + CP in the dMMR/MSI-H and MMRp/MSS subgroups in RUBY Part 1.

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68% reduction in the risk of death observed with JEMPERLI + CP vs CP alone

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  • Estimated Kaplan-Meier probability of survival at 3 years was 78.0% (95% CI: 63.6, 87.3) with JEMPERLI + CP vs 46.0% (95% CI: 32.9, 58.2) with CP alone (HR=0.32; 95% CI: 0.17, 0.63)2†
  • The prespecified exploratory analysis for OS was not powered to detect treatment differences; results are descriptive1,2

Data cutoff 22 September 2023.1
*By Brookmeyer and Crowley method.1
†Based on stratified Cox regression model.1

CI=confidence interval; CP=carboplatin + paclitaxel; dMMR=mismatch repair deficient; HR=hazard ratio; MSI-H=microsatellite instability-high; NR=not reached; OS=overall survival.

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Statistically significant 72% reduction in the risk of progression or death vs CP alone

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  • All-comers median OS was 44.6 months (95% CI: 32.6, NR)* with JEMPERLI + CP vs 28.2 months (95% CI: 22.1, 35.6)* with CP alone (HR=0.69; 95% CI: 0.54, 0.89†; P=0.002‡)1
  • All-comers median PFS was 11.8 months (95% CI: 9.6, 17.1)* with JEMPERLI + CP vs 7.9 months (95% CI: 7.6, 9.5)* with CP alone (HR=0.64; 95% CI: 0.51, 0.80†; P<0.0001‡)1

OS data cutoff 22 September 2023; PFS data cutoff 28 September 2022.1
*By Brookmeyer and Crowley method.1
†Based on stratified Cox regression model.1
‡One-sided P-value based on stratified log-rank test.1

PFS=progression-free survival.

  • DOR/ORR

    ADDITIONAL EFFICACY OUTCOME MEASURES IN THE dMMR/MSI-H SUBGROUP

    Patients Achieved a Durable Response With JEMPERLI + CP3

    Median DOR was not reached at 2+ years3§¶
    Median DOR in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer3

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    • 62.1% probability of remaining in response at 2 years (95% CI: 44.4, 75.5) with JEMPERLI + CP vs 13.2% (95% CI: 4.6, 26.3) with CP alone3#

    More patients responded to JEMPERLI + CP3§

    77.6% of patients with evaluable disease at baseline in the dMMR/MSI-H subgroup responded with JEMPERLI + CP (38/49)

    • 95% CI: 63.4, 88.2
    • CR=30.6%; PR=46.9%

    69.0% of patients with evaluable disease at baseline responded with CP alone (40/58)

    • 95% CI: 55.5, 80.5
    • CR=20.7%; PR=48.3%

    Data cutoff 28 September 2022. Median duration of follow-up of 24.8 months.3
    §    Assessed by investigator according to RECIST v1.1.1
    For patients with a partial or complete response.1
    #Probability of response was estimated from Kaplan-Meier curves.3

    CR=complete response; DOR=duration of response; NE=not estimable; ORR=objective response rate; PR=partial response.

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    • Estimated Kaplan-Meier probability of survival at 3 years was 48.6% (95% CI: 41.0, 55.7) with JEMPERLI + CP vs 41.9% (95% CI: 34.3, 49.4) with CP alone (HR=0.79; 95% CI: 0.60, 1.04)1,2
    • The prespecified exploratory analysis for OS was not powered to detect treatment differences; results are descriptive1,2

    Data cutoff 22 September 2023.1

    MMRp=mismatch repair proficient; MSS=microsatellite stable.

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    • The prespecified exploratory analysis for PFS was not powered to detect treatment differences; results are descriptive1,3

    Data cutoff 28 September 2022.1

  • DOR/ORR

    ADDITIONAL EFFICACY OUTCOME MEASURES IN THE MMRp/MSS SUBGROUP

    Patients Achieved a Durable Response With JEMPERLI + CP3

    Median DOR of nearly 9 months with JEMPERLI + CP3§¶**
    Median DOR in patients with MMRp/MSS primary advanced or recurrent endometrial cancer3

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    • 28.4% probability of remaining in response at 2 years (95% CI: 19.1, 38.4) with JEMPERLI CP vs 13.5% (95% CI: 7.1, 22.0) with CP alone3#

    More patients responded to JEMPERLI + CP3§

    68.1% of patients with evaluable disease at baseline in the MMRp/MSS subgroup responded with JEMPERLI + CP (111/163)

    • 95% CI: 60.4, 75.2
    • CR=23.3%; PR=44.8%

    63.4% of patients with evaluable disease at baseline responded with CP alone (102/161)

    • 95% CI: 55.4, 70.8
    • CR=19.3%; PR=44.1%

    Data cutoff 28 September 2022.3
    §    Assessed by investigator according to RECIST v1.1.1
    For patients with a partial or complete response.1
    #Probability of response estimated from Kaplan-Meier curves.3
    **Analysis of DOR in the MMRp/MSS population was post hoc.3

RUBY Part 1 Trial Design: A phase 3, randomised, double-blind trial of patients with primary advanced or recurrent EC (N=494, all-comers) who were randomised 1:1 to JEMPERLI + CP or placebo + CP Q3W for 6 cycles, followed by JEMPERLI or placebo Q6W, respectively, until disease progression, unacceptable toxicity, or up to 3 years. Major efficacy endpoints were investigator-assessed PFS by RECIST v1.1 in the dMMR/MSI-H and all-comers populations, and OS in all-comers.1

dMMR=mismatch repair deficient; EC=endometrial cancer; MSI-H=microsatellite instability-high; Q3W=every 3 weeks; Q6W=every 6 weeks; RECIST v1.1=Response Evaluation Criteria in Solid Tumours v1.1.

Find Out More

RUBY Part 1 All-Comers Efficacy Data

See Data

RUBY Part 1 Safety Profile

Learn More

JEMPERLI Dosing and Administration

Learn 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 Summary of Product Characteristics. GSK. 2026.
  2. Powell MA, et al. Ann Oncol. 2024;35(8):728-738.
  3. Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
  4. Powell MA, et al. Society of Gynecologic Oncology 2024 Annual Meeting on Women’s Cancer. Presented 16 March 2024.
  5. Ellis LM, et al. J Clin Oncol. 2014;32(12):1277-1280.
  6. Mirza MR, et al. Society of Gynecologic Oncology 2023 Annual Meeting on Women’s Cancer. Presented 27 March 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 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-260003 | March 2026