In the dMMR/MSI-H Endometrial Cancer Subgroup

The RUBY trial had a major efficacy outcome of PFS* with additional efficacy outcomes of OS, ORR, and DOR1,2

RUBY study design infographic

Randomization was stratified by MMR/MSI status, prior external pelvic radiotherapy, and disease status (recurrent, primary Stage III, or primary Stage IV)2

  • * Assessed by the investigator according to RECIST v1.1.2
  • In RUBY, 494 patients underwent randomization to each treatment arm. The safety profile was evaluated in the 241 patients who were randomized to JEMPERLI + CP with primary advanced or recurrent endometrial cancer (EC). The safety data presented on the RUBY safety page reflects exposure to JEMPERLI in 52 patients with dMMR/MSI-H primary advanced or recurrent EC.1,2
  • JEMPERLI was administered prior to chemotherapy on Day 1 of each 21-Day cycle. Treatment with JEMPERLI continued until disease progression, unacceptable toxicity, or a maximum of 3 years.1,2

AUC=area under the curve; CP=carboplatin-paclitaxel; DOR=duration of response; IV=intravenous; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; Q3W=every 3 weeks; Q6W=every 6 weeks; RECIST=Response Evaluation Criteria in Solid Tumors.

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The RUBY trial included patients with broad disease characteristics including those with aggressive histologies2-4

The RUBY trial included patients with broad disease characteristics1,2

Primary FIGO Stage III or Stage IV disease, including patients with more aggressive histologies2-4

Measurable Disease§
Measurable or Non-Measurable Disease§
Stage IIIC1 patients with carcinosarcoma, clear cell, serous, or mixed histology (containing ≥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 those2:

  • 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 recurrent)

All patients in the RUBY trial were anti-PD-1/L1/L2 naïve.5

  • § Measurable or evaluable by RECIST v1.1.

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

The RUBY trial included dMMR/MSI-H endometrial cancer patients with diverse disease characteristics (n=122)1,2,6

RUBY patient baseline characteristics infographic

In the dMMR/MSI-H Endometrial Cancer JEMPERLI + CP Arm

Groundbreaking 71% reduction in the risk of progression or death vs CP alone2

Superior PFS With JEMPERLI + CP vs CP Alone in the dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer Patient Population (n=122)2

Progression-free survival in dMMR/MSI-H RUBY population line graph

See the JEMPERLI difference

Hazard ratio for risk of progression or death with JEMPERLI + CP vs CP alone (HR=0.29, 95% CI: 0.17, 0.50; P<0.0001#)2

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30.3 months median PFS# (95% CI: 11.8, NR) with JEMPERLI + CP compared with 7.7 months (95% CI: 5.6, 9.7) with CP alone2

Overall survival data in the dMMR/MSI-H subgroup were immature with 27% deaths2**

  • HR=0.29 (95% Cl: 0.13, 0.64)
  • OS was a prespecified exploratory analysis in the dMMR/MSI-H subgroup with no planned hypothesis testing, and no conclusions can be drawn from this analysis1
  • OS continues to be evaluated in the dMMR/MSI-H subgroup1
  • Based on stratified Cox regression model.
  • # One-sided p-value based on stratified log-rank test was statistically significant.
  • ** OS in the dMMR/MSI-H subgroup was not powered to demonstrate statistically significant differences.1,6

Median follow-up time was 25 months.1

CI=confidence interval; CP=carboplatin-paclitaxel; HR=hazard ratio; NR=not reached.

In the dMMR/MSI-H Endometrial Cancer JEMPERLI + CP Arm

73.8% objective response rate with JEMPERLI + CP after >2 years of follow-up1,2

RUBY objective response rate graphic

CP alone:
Patients on CP alone achieved a 62.2% ORR (n=28/45, 95% CI: 46.5, 76.2) with 11.1% CR (n=5/45) and 51.1% PR (n=23/45).2

  • †† Confirmed responses as assessed by investigator according to RECIST v1.1.1

Median follow-up time was 25 months.1

CP=carboplatin-paclitaxel; CR=complete response; PR=partial response.

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~1 out of 3 patients who responded achieved a complete response with JEMPERLI + CP (n=11/31)2

In the dMMR/MSI-H Endometrial Cancer JEMPERLI + CP Arm

Duration of response with JEMPERLI + CP after >2 years of follow-up1,2‡‡§§

61.3% (n=19/31) of responders had a DOR >1 year1,2

  • Over half of responders on JEMPERLI + CP had a DOR greater than 1 year compared with 14.3% (n=4/28) of patients on CP alone; 25 months median follow-up time1,2
  • ‡‡ Confirmed responses as assessed by investigator according to RECIST v1.1.
  • §§ For patients with a partial or complete response.
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Median DOR was not reached at 2 years (range: 3.4, 28.3+) after 25 months median follow-up with JEMPERLI + CP compared with median DOR of 5.4 months (range: 2.7, 27.2+) with CP alone1,2

Estimated probability of remaining in response at 2 years for patients in the dMMR/MSI-H endometrial cancer subgroup6¶¶

RUBY Estimated DOR Kaplan Meier (or KM) Curve
  • ¶¶ Probability of response estimated from Kaplan-Meier curves with a median follow-up of 25 months.1,6

DOR=duration of response; NR=not reached.

See the appropriate patient types who may benefit from JEMPERLI + CP

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Icon: JEMPERLI (dostarlimab-gxly) Safety Profile

Learn about the safety profile from the RUBY trial


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