Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 01

731P - Post-progression survival outcomes in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial who received follow-up immunotherapy

Date

14 Sep 2024

Session

Poster session 01

Topics

Tumour Site

Endometrial Cancer

Presenters

Mansoor Raza Mirza

Citation

Annals of Oncology (2024) 35 (suppl_2): S544-S595. 10.1016/annonc/annonc1592

Authors

M.R. Mirza1, C. Mathews2, L. Gilbert3, L. Bjorge4, K. Ring5, M.M. Pishchyk6, K. Pennington7, Y. Segev8, M.A. Powell9, T. Van Gorp10, D. Bender11, K. Schneider12, R. Miller13, A. Armstrong14, G. Canturia15, R. Gogoi16, G. Antony17, S. Stevens18, G. Valabrega19, L.M. Landrum20

Author affiliations

  • 1 Department Of Oncology Clinical Trial Unit, Rigshospitalet, Copenhagen University Hospital, and Nordic Society of Gynaecologic Oncology, Copenhagen, Denmark, 2100 - Copenhagen/DK
  • 2 Gynecology Oncology, Women and Infants Hospital of Rhode Island, 02905 - Providence/US
  • 3 Division Of Gynecologic Oncology, McGill University Health Centre and the Gerald Bronfman Department of Oncology, McGill University, H4A 3J1 - Montreal/CA
  • 4 Department Of Clinical Sciences, Haukeland University Hospital, Bergen, and University of Bergen, 5020 - Bergen/NO
  • 5 Obstetrics And Gynecology, University of Virginia Health System, 22903 - Charlottesville/US
  • 6 Oncology Surgery, Grodno University Clinic, 375-15 - Grodno/BY
  • 7 Gynecologic Oncology, Fred Hutchinson Cancer Center, University of Washington Medical Center, 98109-1024 - Seattle/US
  • 8 Gynecological Oncology Unit, Carmel Medical Center, Technion-Israel Institute of Technology, 3436212 - Haifa/IL
  • 9 Division Of Gynecologic Oncology, National Cancer Institute sponsored NRG–Oncology, Washington University School of Medicine, Washington University in St Louis, 63110-1010 - St Louis/US
  • 10 Division Of Gynaecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, Belgium and the Belgian and Luxembourg Gynaecological Oncology Group (BGOG), 3000 - Leuven/BE
  • 11 Department Of Obstetrics And Gynecology, University of Iowa, 52242 - Iowa City/US
  • 12 Department Of Gynecologic Oncology, Novant Health Cancer Institute, 28204 - Charlotte/US
  • 13 Department Of Obstetrics And Gynecology, Markey Cancer Center, 40536 - Lexington/US
  • 14 Division Of Gynecologic Oncology, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, 44106 - Cleveland/US
  • 15 Gynecologic Oncology, Northside Hospital, University Gynecologic Oncology, 30342 - Atlanta/US
  • 16 Department Of Gynecologic Oncology, Karmanos Cancer Institute, Wayne State University,, 48202 - Detroit/US
  • 17 Biostatistics, GSK, TW8 9GS - London/GB
  • 18 Global Clinical Development. Immuno-oncology, GSK, TW8 9GS - London/GB
  • 19 Department Of Oncology, Ordine Mauriziano Torino and University of Torino, 10137 - Torino/IT
  • 20 Department Of Obstetrics And Gynecology, Indiana University Health & Simon Cancer Center, 46202 - Indianapolis/US

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 731P

Background

In Part 1 of the phase 3 ENGOT-EN6-NSGO/GOG-3031/RUBY trial (NCT03981796), dostarlimab+carboplatin-paclitaxel (DOST+CP) significantly improved PFS (HR 0.64) and OS (HR 0.69) vs placebo (PBO)+CP in the overall population of pts with pA/rEC. Limited data are available on outcomes with follow-up anticancer treatment (FUACT) after DOST+CP. Here we report post-progression survival outcomes of pts in the overall and mismatch repair proficient/microsatellite stable (MMRp/MSS) populations who received FUACT of immunotherapy (IO).

Methods

Pts were randomized 1:1 to receive DOST/PBO+CP Q3W (6 cycles) followed by DOST/PBO monotherapy Q6W for ≤3 years. At interim analysis 2 (37.2 mo of follow-up), updated post hoc analyses of OS adjusted for treatment switching via rank-preserving structural failure time (RPSFT) were performed in the overall and MMRp/MSS populations of pts who received FUACT of IO and for pts receiving pembrolizumab-lenvatinib (PEM-LEN) in the MMRp/MSS population.

Results

In total, 494 pts were randomized (table). FUACT of IO was received by 137 and 102 pts in the overall and MMRp/MSS populations, respectively; PEM-LEN was received by 65 pts in the MMRp/MSS population. Approximately twice as many patients received FUACT of IO in the PBO+CP vs DOST+CP arm. When adjusted for subsequent IO, RPSFT analyses showed HRs of 0.63 (overall) and 0.76 (MMRp/MSS) for DOST+CP vs PBO+CP, consistent with the unadjusted HRs for OS in the primary analysis. In the MMRp/MSS population receiving subsequent PEM-LEN, HR of RPSFT-adjusted OS was also consistent at 0.77.

Table: 731P

Overall MMRp/MSS
DOST+CP PBO+CP DOST+CP PBO+CP
N 245 249 192 184
OS (95% CI) 0.69(0.54–0.89) 0.79(0.60–1.04)
Any FUACT, n, %
Any IO a 42 (17.1) 95 (38.2) 34 (17.7) 68 (37.0)
PEM-LEN 25 (10.2) 45 (18.1) 22 (11.5) 43 (23.4)
RPSFT-adjusted OS
Follow-up any IO HR (95% CI) 0.63(0.46–0.87) 0.76(0.54–1.06)
AF b 1.64 1.28
Follow-up PEM-LENHR (95% CI) 0.77 (0.56–1.06)
AF b 1.25

aImmunotherapies: PEM, PEM-LEN, PEM-tamoxifen, DOST, retifanlimab/epacadostat, durvalumab combinations, investigational product, atezolizumab combinations, bevacizumab/atezolizumab, MK7694A, and nivolumab combinations.

bDOST+CP increases survival by acceleration factor (AF).

Conclusions

Adjusted OS using RPSFT for subsequent use of IO in the overall and MMRp/MSS populations, including PEM-LEN in the MMRp/MSS population, showed limited impact on survival benefits, supporting frontline use of dostarlimab+CP as standard of care in all pts with pA/rEC.

Clinical trial identification

NCT03981796.

Editorial acknowledgement

Writing and editorial support, funded and coordinated by GSK, was provided by Shannon Morgan-Pelosi, PhD, CMPP, and editor TBD, of Ashfield MedComms, an Inizio company.

Legal entity responsible for the study

GSK.

Funding

GSK.

Disclosure

M.R. Mirza: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zailab; Financial Interests, Institutional, Research Funding: Apexigen, AstraZeneca, Deciphera (trial chair), GSK, Ultimovacs; Financial Interests, Personal, Stocks/Shares: Karyopharm ; Financial Interests, Personal, Member of Board of Directors: Karyopharm. C. Mathews: Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, Deciphera, Moderna, GSK, Regeneron, Seattle Genetics; Financial Interests, Personal, Advisory Board: IMAB biopharma. L. Gilbert: Financial Interests, Institutional, Advisory Board: Alkermes, AstraZeneca, Clovis, Corcept Therapeutics, Esperas, GOG Foundation, GSK, ImmunoGen, IMV, K-Group Beta, Karyopharm, Merck Sharp & Dohme, Mersana Therapeutics, Novocure GmbH, OncoQuest Pharmaceuticals, Roche, Shuttuck Labs, Sutro BioPharma Inc, Tesaro; Financial Interests, Personal, Speaker, Consultant, Advisor: GSK, Merck; Financial Interests, Personal, Other, honoraria: CanariaBio, Eisai, Eisai-Merck, GOG Foundation, GSK, ImmunoGen, Kora Healthcare, Merck; Financial Interests, Personal, Other, travel support: EndomEra, GOG Foundation, GSK, Merck, Zentalis; Financial Interests, Personal, Other, participation on a Data Safety Monitoring Board: CanariaBio, Eisai, Eisai-Merck, GOG Foundation, GSK, ImmunoGen, Kora Healthcare, Merck. L. Bjorge: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK. M.A. Powell: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Clovis Oncology, Eisai, GSK, Merck, Seagen, Tesaro. T. Van Gorp: Financial Interests, Institutional, Research Funding: Amgen, AstraZeneca, Roche; Financial Interests, Institutional, Speaker, Consultant, Advisor: AbbVie, AstraZeneca, BioNTech, Cancer Communications and Consultancy Ltd, Eisai, GSK, ImmunoGen, Inc., Incyte, Karyopharm, MSD/Merck & Co., OncXerna Therapeutics, Seagen, Tubulis, Zentalis; Financial Interests, Institutional, Other, Support for attending meetings and/or travel: AstraZeneca, ImmunoGen, Inc., MSD/Merck, PharmaMar; Financial Interests, Personal, Non remunerated activity, Chair: Belgian and Luxembourg Gynaecological Oncology Group. D. Bender: Financial Interests, Institutional, Other, grants: AbbVie, AstraZeneca, Clovis Oncology Inc, Genentech, MSD, Tesaro. G. Canturia: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK; Other, Personal, Other, patent on an anti-tumor lipid molecule that is early stage of development: TBD. R. Gogoi: Non-Financial Interests, Personal, Advisory Board, or data safety monitoring board: Pionyr Pharmaceuticals; Financial Interests, Personal, Other, receipt of equipment, materials, drugs, medical writing, gifts or other services: Bausch + Lomb. G. Antony: Financial Interests, Personal, Full or part-time Employment: GSK. S. Stevens: Financial Interests, Personal, Full or part-time Employment: GSK. G. Valabrega: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK; Financial Interests, Personal, Other, honoraria: AstraZeneca, GSK, MSD; Financial Interests, Personal, Other, travel support: AstraZeneca, PharmaMar; Non-Financial Interests, Personal, Advisory Board: AstraZeneca, EISAI, GSK, MSD. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.