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RUBY Part 1 Trial Results

Learn more about the efficacy results of JEMPERLI + CP in all-comers (overall population) in RUBY Part 1.

NA NA

Statistically significant 31% reduction in the risk of death with JEMPERLI + CP vs CP alone1,2

NA NA
  • Estimated Kaplan-Meier probability of survival at 3 years was 54.9% (95% CI: 48.2, 61.2) with JEMPERLI + CP vs 42.9% (95% CI: 36.3, 49.3) with CP alone (HR=0.69; 95% CI: 0.54, 0.89†; P=0.002‡)1,2

Data cutoff 22 September 2023.1
*By Brookmeyer and Crowley method.1
†Based on stratified Cox regression model.1
‡One-sided P-value based on stratified log-rank test.1

CI=confidence interval; CP=carboplatin + paclitaxel; HR=hazard ratio; NR=not reached; OS=overall survival.

NA NA

Statistically significant 36% reduction in the risk of progression or death with JEMPERLI + CP vs CP alone

NA NA
  • dMMR/MSI-H subgroup median PFS (a primary efficacy endpoint) was not reached (95% CI: 11.8, NR)* with JEMPERLI + CP after >2 years of follow-up compared with 7.7 months (95% CI: 5.6, 9.7)* with CP alone (HR=0.28; 95% CI: 0.16, 0.50†; P<0.0001‡)1

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 ALL-COMERS POPULATION

    Patients Achieved a Durable Response With JEMPERLI + CP3

    Median DOR of nearly 11 months with JEMPERLI + CP3§¶
    Median DOR in patients with primary advanced or recurrent endometrial cancer3

    NA NA
    • 38.0% probability of remaining in response at 2 years (95% CI: 29.4, 46.5) with JEMPERLI + CP vs 13.0% (95% CI: 7.5, 20.2) with CP alone3#

    More patients responded to JEMPERLI + CP3§

    70.3% of patients with evaluable disease at baseline in the all-comers population responded with JEMPERLI + CP (149/212)

    • 95% CI: 63.6, 76.3
    • CR=25.0%; PR=45.3%

    64.8% of patients with evaluable disease at baseline responded with CP alone (142/219)

    • 95% CI: 58.1, 71.2
    • CR=19.6%; PR=45.2%

    Data cutoff 28 September 2022. Median duration of follow-up of 25.4 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; ORR=objective response rate; PR=partial response.

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 Subgroup Efficacy Data

See Data

RUBY Part 1 Safety Profile

Learn More

JEMPERLI Dosing and Administration

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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. Bogani G, et al. Int J Gynecol Cancer. 2023;33(2):147-174.
  5. Clarke MA, et al. J Clin Oncol. 2019;37(22):1895-1908.

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-260002 | May 2026