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Learn more about the efficacy results of JEMPERLI + carboplatin-paclitaxel (CP) in the dMMR/MSI-H subgroup of the RUBY trial.
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*
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
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<0.0001)1*
Median follow-up time was 25 months1
*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*
- 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 follow-up time was 25 months1
- 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 + CP2
Objective Response Rate2*
>1 out of 3 Patients Who Responded to Treatment Achieved a Complete Response With JEMPERLI + CP (n=15/38)2
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*†‡
Estimated probability of DOR in the dMMR/MSI-H subgroup (n=118)2*†‡
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*†
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
JEMPERLI Dosing and Administration
JEMPERLI Support and Resources
JEMPERLI Is Indicated7
- in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
- as monotherapy for the treatment of adult patients with dMMR/ MSI‑H recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.
Jemperli Safety Information7
Contraindications:
Hypersensitivity to the active substance or to any of the excipients
Adverse reactions:
Dostarlimab monotherapy:
Very common: Anaemia, Hypothyroidism, Diarrhoea, nausea, vomiting, Rash, pruritus, Arthralgia, Pyrexia and Transaminases increased
Common: Hyperthyroidism, adrenal insufficiency, Pneumonitis, Colitis , pancreatitis, gastritis, Hepatitis, Myalgia, Chills and Infusion-related reaction
Dostarlimab in combination therapy:
Very common: Hypothyroidism, Rash, dry skin, Pyrexia, Alanine aminotransferase increased and aspartate aminotransferase increased
Common: Hyperthyroidism, adrenal insufficiency, Pneumonitis and Colitis
References
- JEMPERLI Summary of Product Characteristics. GSK. 2023.
- Mirza MR, et al. N Engl J Med. 2023;388(23):2145-2158.
- Bogani G, et al. Int J Gynecol Cancer. 2023;33(2):147-174.
- Clarke MA, et al. J Clin Oncol. 2019;37(22):1895-1908.
- ClinicalTrials.gov. Accessed July 24, 2023. https://www.clinicaltrials.gov/study/NCT03981796?cond=NCT03981796
- Mirza MR, et al. Society of Gynecologic Oncology 2023 Annual Meeting on Women’s Cancer. Presented March 27, 2023.
- Jemperli Local PI
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Department of Pharmacovigilance & Drug Information |
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February 2025 | PM-AE-DST-WCNT-250001
