• HOME
  • NEWS
  • EXPLORE
    • CAREER
      • Companies
      • Jobs
    • EVENTS
    • iGEM
      • News
      • Team
    • PHOTOS
    • VIDEO
    • WIKI
  • BLOG
  • COMMUNITY
    • FACEBOOK
    • INSTAGRAM
    • TWITTER
  • CONTACT US
Sunday, May 28, 2023
BIOENGINEER.ORG
No Result
View All Result
  • Login
  • HOME
  • NEWS
  • EXPLORE
    • CAREER
      • Companies
      • Jobs
        • Lecturer
        • PhD Studentship
        • Postdoc
        • Research Assistant
    • EVENTS
    • iGEM
      • News
      • Team
    • PHOTOS
    • VIDEO
    • WIKI
  • BLOG
  • COMMUNITY
    • FACEBOOK
    • INSTAGRAM
    • TWITTER
  • CONTACT US
  • HOME
  • NEWS
  • EXPLORE
    • CAREER
      • Companies
      • Jobs
        • Lecturer
        • PhD Studentship
        • Postdoc
        • Research Assistant
    • EVENTS
    • iGEM
      • News
      • Team
    • PHOTOS
    • VIDEO
    • WIKI
  • BLOG
  • COMMUNITY
    • FACEBOOK
    • INSTAGRAM
    • TWITTER
  • CONTACT US
No Result
View All Result
Bioengineer.org
No Result
View All Result
Home NEWS Science News Health

ENGOT-EN6-NSGO/GOG-3031/RUBY trial results: The new standard of care in advanced/recurrent endometrial cancer

Bioengineer by Bioengineer
March 27, 2023
in Health
Reading Time: 5 mins read
0
Share on FacebookShare on TwitterShare on LinkedinShare on RedditShare on Telegram

EMBARGO DATE: Monday, March 27, 2023, 12:30 pm ET

European Network of Gynaecological Oncological Trial Groups

Credit: ENGOT

EMBARGO DATE: Monday, March 27, 2023, 12:30 pm ET

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



Method of Research

Randomized controlled/clinical trial

Subject of Research

People

Share12Tweet8Share2ShareShareShare2

Related Posts

Achala Vagal

Study finds distinct patterns of pre-existing brain health characteristics in stroke patients

May 27, 2023
Production of a biomedical microfibre

Basis for skin and organ production: Researchers from Graz University of Technology revolutionize production of biocompatible microfibers

May 26, 2023

A detailed map of Urban Heat Islands

May 26, 2023

How eating natto might help to distress

May 26, 2023

POPULAR NEWS

  • the University of Haifa

    Groundbreaking study uncovers first evidence of long-term directionality in the origination of human mutation, fundamentally challenging Neo-Darwinism

    115 shares
    Share 46 Tweet 29
  • How life and geology worked together to forge Earth’s nutrient rich crust

    35 shares
    Share 14 Tweet 9
  • Element creation in the lab deepens understanding of surface explosions on neutron stars

    34 shares
    Share 14 Tweet 9
  • The case for engineering our food

    73 shares
    Share 29 Tweet 18

About

We bring you the latest biotechnology news from best research centers and universities around the world. Check our website.

Follow us

Recent News

Study finds distinct patterns of pre-existing brain health characteristics in stroke patients

New moms and dads left unprepared for parenthood by government health ‘failures’, report warns

Absolute vs. relative efficiency: How efficient are blue LEDs, actually?

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Join 50 other subscribers
  • Contact Us

Bioengineer.org © Copyright 2023 All Rights Reserved.

No Result
View All Result
  • Homepages
    • Home Page 1
    • Home Page 2
  • News
  • National
  • Business
  • Health
  • Lifestyle
  • Science

Bioengineer.org © Copyright 2023 All Rights Reserved.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In