PRESS RELEASE
ENGOT-EN6-NSGO/GOG-3031/RUBY trial results:
The new standard of care in advanced/recurrent endometrial cancer
ENGOT, NSGO-CTU & GOG-Foundation proudly announce the ground-breaking results of ENGOT-EN6-NSGO/GOG-3031/RUBY trial.
The results reveal improvement in overall survival at 24 months in whole study population from 56% (CP+placebo) to 71.3% (CP+dostarlimab). “although these are interim data, we believe they are robust and will be confirmed with longer follow-up.”, said Mansoor R Mirza.
The trial is presented on 27th of March 2023 through ESMO’s Virtual Plenary and at the Society of Gynecologic Oncology’s (SGO) Annual Meeting on Women’s Cancer. The trial’s results are simultaneously published in the New England Journal of Medicine, demonstrate unprecedented improvement in Progression-Free Survival and Overall Survival of patients with primary advanced or recurrent endometrial cancer (EC) when treated with dostarlimab in combination with standard of care carboplatin/paclitaxel (CP) followed by dostarlimab monotherapy compared to chemotherapy alone.
“Carboplatin/paclitaxel is the standard of care for first-line treatment of primary advanced or recurrent endometrial cancer; however long-term outcomes remain poor, with median overall survival of less than 3 years. Anti–PD-1 based therapy has transformed the management of endometrial cancer post-platinum chemotherapy, however, advances in first-line systemic treatment were urgently needed”, says study chair Mansoor Raza Mirza (NSGO-CTU). “These results are unprecedented and shall considerably improve the outcome of our patients”.
Statement by ENGOT President Prof. Nicoletta Colombo:
“The results of this ENGOT-GOG-F trial represent an incredible step forward in our battle against advanced endometrial cancer. Our patients can now benefit from a new first line standard of care able to significantly prolong progression-free survival and potentially overall survival. Another success of the strong collaboration among gynecologic oncology groups worldwide. “
Statement by GOG-F President, Larry J. Copeland, MD:
“This trial’s practice changing results help all patients who are undergoing treatment for advanced endometrial cancer. ENGOT and the GOG Foundation’s goals are to improve the lives of patients through clinical trials. This important research allows discovery of new and effective therapies to transform the standard of care in gynecologic oncology. Our collaborative efforts continue to bring treatments to our patients sooner.”
About RUBY Trial
The RUBY trial is a phase 3, randomized, double-blind, multicenter, placebo-controlled study. Eligible patients with primary advanced stage III or IV or first recurrent endometrial cancer were randomized 1:1 to receive dostarlimab, or placebo, plus carboplatin/paclitaxel (CP) combination, followed by dostarlimab or placebo monotherapy. Of 494 patients randomized, 118 (23.9%) had dMMR/MSI-H tumors. Progression-free survival (PFS) was significantly longer in the dostarlimab plus CP arm than the placebo plus CP arm in patients with dMMR/MSI-H tumors and in the overall population. In the dMMR/MSI-H population, the estimated Kaplan-Meier (KM) probability of PFS at 24 months was 61.4% (95% CI, 46.3–73.4) with dostarlimab–CP and 15.7% (95% CI, 7.2–27.0) with placebo–CP (HR, 0.28; 95% CI, 0.162–0.495; P<0.0001). In the overall population, estimated KM probability of PFS at 24 months was 36.1% (95% CI, 29.3–42.9) with dostarlimab–CP and 18.1% (13.0–23.9) with placebo–CP(HR, 0.64; 95% CI, 0.507–0.800; P<0.0001). The estimated KM probability of overall survival (OS) at 24 months was 71.3% (95% CI, 64.5–77.1) with dostarlimab plus CP and 56.0% (95% CI, 48.9–62.5) placebo plus CP (HR, 0.64; 95% CI, 0.464–0.870). The safety profile of the combination was generally consistent with safety profiles of the individual components. The most common treatment emergent adverse events reported for dostarlimab–CP compared with placebo–CP arms were nausea (53.9% and 45.9%), alopecia (53.5% and 50.0%), and fatigue (51.9% and 54.5%).
In conclusion, Dostarlimab + CP demonstrated statistically significant and clinically meaningful PFS benefit with an early OS trend:
Substantial, unprecedented benefit in dMMR/MSI-H patients
Clinically meaningful long-term benefit observed in MMRp/MSS patients
Dostarlimab plus carboplatin/paclitaxel represents a new standard of care for patients with primary advanced or recurrent endometrial cancer
(Funded by GSK/Tesaro Inc.; RUBY ClinicalTrials.gov number, NCT03981796.)
About NSGO-CTU (www.nsgo.org)
The Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU) is a non-profit organization aiming to improve the practice of prevention, diagnosis and treatment for gynaecological cancers by supporting research and conducting clinical trials across countries.
About ENGOT (www.engot.esgo.org)
The European Network for Gynaecological Oncological Trial (ENGOT) groups is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Currently, ENGOT consists of 21 trial groups from 31 European countries that perform cooperative clinical trials. ENGOT’s ultimate goal is to bring the best treatment to gynecological cancer patients through the best science and enabling every patient in every European country to access a clinical trial.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.
About the GOG Partners Program
Supported by industry, GOG Partners program is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners program promotes the mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.
About Endometrial Cancer
Endometrial cancer is the most common reproductive cancer affecting women within the United States, estimated to account for approximately 65,950 newly diagnosed cases in 2022. [ACS, 2022a] Although the average age at diagnosis for women with endometrial cancer is 60 years, a proportion of patients are diagnosed prior to menopause. [ACS, 2022a] Endometrial endometrioid adenocarcinoma is most commonly diagnosed when confined to the uterus, representing 67% of cases; however, the National Comprehensive Cancer Network (NCCN) reports that in 2017, 21% and 8% of cases were diagnosed as regional and distant diseases, respectively. [NCCN v1.2022c]
Despite currently available treatment options, it was estimated that there would be nearly 12,550 endometrial cancer related deaths in the United States in 2022. [ACS, 2022b] Unfortunately, women with metastatic and recurrent endometrial cancer have unfavorable prognosis, with an estimated 5-year survival rate of 20%. [ACS, 2022b]
aAmerican Cancer Society. Key Statistics for Endometrial Cancer. 2022, February 14. Accessed on August 4, 2022 from https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html
bAmerican Cancer Society. Survival Rates for Endometrial Cancer. 2022, February 28. Accessed August 3, 2022 from https://www.cancer.org/cancer/endometrial-cancer/detection-diagnosis-staging/survival-rates.html
cNational Comprehensive Cancer Network. Uterine Neoplasms. Version 1.2022-November 4, 2021. Accessed on August 10, 2022 from https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf
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