ENGOT-EN6-NSGO/GOG-3031/RUBY trial results:

The new standard of care in advanced/recurrent endometrial cancer

ENGOT-EN6-NSGO/GOG-3031/RUBY trial results:

The new standard of care in advanced/recurrent endometrial cancer

Mansoor Raza Mirza, MD

Study Chair &
Medical Direcor of NSGO-CTU

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 the 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”.

Link to the NEJM article

“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. “

Prof. Nicoletta Colombo

President of ENGOT

“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 discoveries 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.”

Larry J. Copeland, MD

President of GOG-F

About THE 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. 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 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

Collaborators

Collaborators

NSGO-CTU

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.

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.

ENGOT

www.engot.esgo.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.

The GOG Foundation, Inc.

www.gog.org

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Privacy Policy for NSGO

NSGO treats personal information and complies with the laws and principles of good data processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO is the data controller and you can always contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
Mansoor.Raza.Mirza@regionh.dk.

We treat the following personal information about members:

  • General personal information: For example, contact information such as name, work address, work phone number, private phone number, date of birth, email address, country, work title, date of membership, date of membership termination and cv in relation to membership application. Parts of credit card number via Epay and, if applicable, Bank account number for reimbursement purposes. When applicable, Board Members may be asked to give NSGO copies of other personal documents (for example passport or tax bill) in relation to the Danish Laundering Act.
  • Other information: For example, positions of trust, board membership and other duties in relation to the organization.

We collect personal information from:

Usually we will get the information from you, when you register to become a member of NSGO and when you apply for reimbursements or pay your membership fee

The organization’s legal basis to process personal information:

  • That we as an organization have a (legitimate) interest in processing your information
  • That it is necessary for us to fulfill an agreement with you
  • You have agreed that we can process your information via becoming a member of the

The purpose of processing personal information:

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  • To invite to vote for Board and President Elect elections
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  • To notify members about other Gynecologic Cancer Managing your relationship with the organization
  • To handle your membership rights
  • For you to fulfill your obligations as a member of the organization, including paying the membership fee, etc.
  • Being able to display situation images from a specific event in the organization for instance from NSGO Annual Meetings
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Consent:

When you become a member, we have a legal basis to process your personal information for the (legitimate) interest of the organization. However, it may happen that we judge it necessary to obtain your written consent for other purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it at any time by notifying us.

Dispatch of your personal information:

We do not disclose information about you to anyone outside the organization without your consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your personal information might be forwarded to the meeting location or the meeting organizer. Only personal information relevant for the 3rd party will be disclosed in these circumstances.

Storing and deleting your personal information:

For historical reasons and as your details might be saved in old attendance lists, email correspondence and minutes from meetings, we cannot promise that all personal information about you will be deleted, if you terminate your membership.

Your rights:

You have a number of rights via the General Data Protection Regulation (GDPR):

  • The Right to Information (to be informed what information we process about you)
  • The Right to Rectification (to have false information about you corrected)
  • The Right to Restriction of processing (under certain conditions, to have the processing of your data restricted)
  • The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us. If you submit a request to have your personal information corrected or deleted, we will investigate whether the conditions are met and, in that case, make changes or deletions as soon as possible and, if applicable, also notify our data processors to do so.

You can file a complaint with the supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information (www.datatilsynet.dk).

Revision of Privacy Policy:

We reserve the right to change the organization’s privacy policy. When we change privacy policy, we also change the date and version number at the bottom of this document. In case of significant changes, you will receive a notification.

The current privacy policy is always available on our website.

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Privacy Policy for NSGO-CTU

NSGO-CTU treats personal information and complies with the laws and principles of good data
processing practices. Therefore, we have adopted this Privacy Policy, which briefly describes how we treat personal information, so legal and transparent processing is ensured.

We are responsible for processing your personal information:

NSGO-CTU is the data controller and you can contact the organization’s data protection officer:

Mansoor Raza Mirza

Nordic Society of Gynecologic Oncology – Clinical Trial Unit
Copenhagen University Hospital
Department of Oncology, 9431
Blegdamsvej 60
DK-2100 Copenhagen
Office phone: +45 35 45 33 78
fax: +45 3545 2898
Mansoor.Raza.Mirza@regionh.dk.

We treat the following personal information about personnel participating in NSGO-CTU trials:
• General personal information: For example; contact information such as name, work
address, work phone number, date of birth, email address, country, work title, date of start
of participation and termination in a trial and, if applicable, CV, GCP certificates, records of
training and other qualification data.
• If applicable, financial disclosure forms and/or Bank account number for reimbursement
purposes.

We collect personal information from:
• We will ask you to provide us the information yourself, when you in decide to take part
in NSGO-CTU trials.
The organization’s legal basis to process personal information:
• That we as an organization have a (legitimate) interest in processing your information, for
example to secure your qualifications in handling the care of the participants in a trial.
• That it is necessary for us to fulfill an agreement with your employer
• You have agreed that we can process your information via signing the delegation log.
The purpose of processing personal information:
• The participation of an investigator or of other individuals in a clinical trial which is being
conducted according to the principals governing clinical research as set out in the
Declaration of Helsinki and with the acceptance of all involved Regulatory Health
Authorities and involved Ethical Committees, requires collection, recording, storage,
transfer and/or other use of personal data (personal data processing).
• Communicate regarding studies.
• To handle payments and reimbursements.
• To comply with legislation.
• To deliver services, in the form of the possibility to participate in the Annual Meeting,
Investigator Meeting.
• To be able to give you access to IT systems, databases, eCRFs etc. related to the functioning
of each individual trial.

Consent:
When you decide to take part in a NSGO-CTU trial NSGO-CTU either makes a contract with you or
your employer where terms and conditions are described, or if you put your name on the
Delegation Log of a trial, you agree to the information described in this Privacy Policy.
However, it may happen that we judge it necessary to obtain your written consent for other
purposes. In that case you will have the opportunity to voluntarily agree, and you may withdraw it
at any time by notifying us.
Be aware that there are legal bases for certain forms of processing of your data for the abovementioned purposes and that your consent is the only legal basis for other forms of processing.

Dispatch of your personal information:
Depending on your role in a trial, your personal information might be shared with personnel at
other sites, monitors, group staff in other countries, NSGO-CTU office staff, members of NSGO,
CRO staff, Ethics Committees and Competent Authorities, both in Europe, but also in countries
outside the European Economic Area (for example the US). If your data (personal information) has
been transferred, they will be subject to the data protection legislation of the respective country,
also if a less severe data protection law should exist.
We do not disclose information about you to anyone outside the organization without the above
consent, however, it should be noted, that if you e.g. accept an invitation to a meeting, your
personal information might be forwarded to the meeting location or the meeting organizer. Only
personal information relevant for the 3rd party will be disclosed in these circumstances.
Furthermore, your data can be transmitted to public databases for registration, as well as
publication of a trial and your data can be stored and published in those databases.
Storing and deleting your personal information:
For historical reasons and as your details might be saved in old attendance lists, email
correspondence and minutes from meetings, we cannot promise that all personal information
about you will be deleted, when you end your participation in a study. In general, all information
about a trial is deleted at least 20 years after end of study.

Your rights:
You have a number of rights via the General Data Protection Regulation (GDPR):
• The Right to Information (to be informed what information we process about you)
• The Right of Access (to get a print of the information we process about you)
• The Right to Rectification (to have false information about you corrected)
• The Right to Erasure (to delete information we process about you, however, information
already received cannot be deleted)
• The Right to Restriction of processing (under certain conditions, to have the processing of
your data restricted)
• The Right to Object (to object to your information being used for wrong purposes)

You may make use of your rights by contacting us, however, the legality of the processing carried out
prior to e.g., a withdrawal will not be affected. If you submit a request to have your personal
information corrected or deleted, we will investigate whether the conditions are met and, in that
case, make changes or deletions as soon as possible and, if applicable, also notify our data
processors to do so.

If you do not believe that NSGO-CTU handles your data correctly, you can file a complaint with the
supervisory authorities – The Danish ‘Datatilsynet’ – About processing your personal information
(www.datatilsynet.dk).

Revision of Privacy Policy:
We reserve the right to change the organization’s privacy policy. When we change privacy policy,
we also change the date and version number at the bottom of this document. In case of significant
changes, you will receive a notification.

The current privacy policy for NSGO-CTU is always available on our website.

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