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Poster session 11

750P - PFS2 and adjustment of overall survival (OS) for subsequent anticancer therapy in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) treated with dostarlimab plus chemotherapy or chemotherapy alone in the ENGOT-EN3-NSGO/GOG-3031/RUBY trial

Date

21 Oct 2023

Session

Poster session 11

Topics

Clinical Research;  Immunotherapy

Tumour Site

Endometrial Cancer

Presenters

Brian Slomovitz

Citation

Annals of Oncology (2023) 34 (suppl_2): S507-S542. 10.1016/S0923-7534(23)01937-3

Authors

B.M. Slomovitz1, N. Raaschou-Jensen2, R.L. Coleman3, L. Gilbert4, M.A. Powell5, D. Cibula6, S. Ghamande7, L. Zavallone8, A.A. Mendivil9, B. Ataseven10, D. Black11, M. Wymenga12, C. Billingsley13, L.J. Willmott14, C. McCourt15, I. Podzielinski16, O. Doehring17, J. Garside18, T.J. Herzog19, M.R. Mirza20

Author affiliations

  • 1 Department Of Gynecologic Oncology, Mount Sinai Medical Center, and the Department of Obstetrics and Gynecology, Florida International University, 33140 - Miami Beach/US
  • 2 Department Of Oncology, Herlev Hospital, Herlev, and Nordic Society of Gynaecological Oncology, 2730 - Copenhagen/DK
  • 3 Department Of Gynecologic Oncology, Sarah Cannon Research Institute, Nashville/US
  • 4 Division Of Gynecologic Oncology, McGill University Health Centre, H4A 3J1 - Montreal/CA
  • 5 Department Of Oncology, National Cancer Institute sponsored NRG Oncology, Washington University School of MedicineG Oncology, Washington University School of Medicine, St. Louis/US
  • 6 Department Of Obstetrics And Gynecology, General University Hospital in Prague, First Faculty of Medicine, Charles University, 121 11 - Prague/CZ
  • 7 Department Of Gynecological Oncology, Georgia Cancer Center, August University, 30912 - Augusta/US
  • 8 Department Of Medical Oncology, Infermi Hospital, 13900 - Biella/IT
  • 9 Gynecologic Oncology Associates, Hoag Cancer Center, 92663 - Newport Beach/US
  • 10 Department Of Gynecology, Gynecologic Oncology And Obstetrics, Klinikum Lippe, Bielefeld University, Medical School and University Medical Center East Westphalia-Lippe, Detmold/DE
  • 11 Department Of Obstetrics And Gynecology, LSU Health Shreveport and Willis-Knighton Physician Network, Shreveport/US
  • 12 Department Of Internal Medicine, Medisch Spectrum Twente, 7512 KZ - Enschede/NL
  • 13 Division Of Gynecologic Oncology, University of Cincinnati Medical Center, 45267 - Cincinnati/US
  • 14 Department Of Gynecologic Oncology, Arizona Center for Cancer Care, 85016 - Phoenix/US
  • 15 Division Of Gynecologic Oncology, Washington University School of Medicine, Washington University in St. Louis, 63110 - St. Louis/US
  • 16 Department Of Gynecologic Oncology, Parkview Health, 46845 - Fort Wayne/US
  • 17 Oncology Statistics, GSK, UB6 0HE - London/GB
  • 18 Oncology Statistics, GSK, London/GB
  • 19 Department Of Obstetrics And Gynecology, University of Cincinnati Cancer Center, 45219 - Cincinnati/US
  • 20 Department Of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, and Nordic Society of Gynaecological Oncology-Clinical Trial Unit, 2100 - Copenhagen/DK

Resources

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Abstract 750P

Background

The RUBY trial (NCT03981796) evaluated the efficacy and safety of dostarlimab (D)+carboplatin-paclitaxel (CP) vs CP alone in pA/rEC. D+CP significantly improved progression-free survival (PFS) in the mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H; HR, 0.28) and overall population (HR, 0.64) with a favorable OS trend (HR, 0.64). Here, PFS2 and OS adjusted for subsequent anticancer therapy are reported.

Methods

Pts were randomised 1:1 to receive D+CP or placebo (PBO)+CP Q3W for 6 cycles, followed by D or PBO monotherapy Q6W for up to 3 years. PFS2 was a secondary endpoint for the dMMR/MSI-H and overall populations. Post hoc treatment switching-adjustment (for subsequent use of dostarlimab, pembrolizumab, durvalumab, nivolumab, or pembrolizumab with lenvatinib) was implemented using 2 methods: inverse probability of censoring weighting (IPCW) and rank-preserving structural failure time (RPSFT).

Results

Of 494 pts randomised (D+CP, n=245; PBO+CP, n=249), 118 were dMMR/MSI-H (D+CP, n=53; PBO+CP, n=65). Overall, 15.5% of pts in the D+CP arm and 34.5% of pts in the PBO+CP arm received subsequent immunotherapy. PFS2 benefit was observed with D+CP for all populations (Table). When adjusted for subsequent therapy, the HRs for OS for D+CP vs PBO+CP for both IPCW and RPSFT were similar to the unadjusted HR for OS in all populations, with increased survival with D+CP (Table). Safety was reported previously.

Conclusions

Consistent with results of the primary efficacy analysis, dostarlimab+CP demonstrates PFS2 and OS benefits vs PBO+CP in pts with pA/rEC despite the use of subsequent therapies. These results provide additional support for the use of dostarlimab+CP as standard of care in pts with pA/rEC. Table: 750P

dMMR/MSI-H MMRp/MSS Overall
Variable, HR (95% CI) D+CP N=53 PBO+CP N=65 D+CP N=192 PBO+CP N=184 D+CP N=245 PBO+CP N=249
PFS a 0.28 (0.16–0.50) P<0.0001 0.76 (0.59–0.98) 0.64 (0.51–0.80) P<0.0001
PFS2 0.37 (0.19–0.73) 0.71 (0.54–0.95) 0.65 (0.50–0.84)
Subsequent immunotherapy, n (%) 8 (15.1) 25 (38.5) 30 (15.6) 61 (33.2) 38 (15.5) 86 (34.5)
OS 0.30 (0.13–0.70) 0.73 (0.52–1.02) 0.64 (0.46–0.87) P=0.0021
IPCW, n 52 65 188 181 240 246
IPCW-adj OS 0.35 (0.12–1.00) 0.67 (0.44–1.03) 0.62 (0.42–0.90)
RPSFT, n 53 65 192 184 245 249
RPSFT-adj OS 0.24 (0.09–0.67) 0.69 (0.47–1.03) 0.59 (0.41–0.85)
Acceleration factor b 3.465 1.408 1.613

aInvestigator assessment per RECIST v1.1 bD+CP increases survival by AF

.

Clinical trial identification

NCT01847274.

Editorial acknowledgement

Writing and editorial support, funded and coordinated by GSK, was provided by Shannon Morgan-Pelosi, PhD, and Mary C. Wiggin, of Ashfield MedComms, an Inizio company.

Legal entity responsible for the study

GSK.

Funding

GSK.

Disclosure

B.M. Slomovitz: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis, Eisai, GSK, Genentech, Merck, Immunogen, Novocure; Financial Interests, Personal, Other, consultant: GOG Foundation; Non-Financial Interests, Member of Board of Directors: GOG Foundation. N. Raaschou-Jensen: Financial Interests, Personal, Advisory Board: Eisai. R.L. Coleman: Financial Interests, Personal, Advisory Board: AstraZeneca, agenus, Alkermes, Immunogen, Roche/Genentech, GSK, Genmab/Seagen, Epsilogen, Myriad Genetics; Financial Interests, Personal, Invited Speaker: AstraZeneca, Genmab/Seagen; Non-Financial Interests, Principal Investigator: abbvie, immunogen, Roche/Genentech, Merck, Genmab, Clovis; Non-Financial Interests, Project Lead, MyLung Consortium: US Oncology Research. L. Gilbert: Financial Interests, Institutional, Funding: Alkermes, AstraZeneca, Clovis, Esperas, IMV, ImmunoGen Inc, Karyopharm, Merck Sharp & Dohme, Mersana, Novocure GmbH, OncoQuest Pharmaceuticals, Pfizer, Roche, Tesaro; Financial Interests, Personal, Speaker, Consultant, Advisor: Merck, Alkermes, AstraZeneca, Eisai, Eisai-Merck, GSK. M.A. Powell: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK, Tesaro, Merck, Eisai, Seagen, Clovis Oncology, AstraZeneca. D. Cibula: Financial Interests, Personal, Advisory Board: Roche, SOTIO, Novocure, MSD, GSK, Akesobio, Seagen; Financial Interests, Personal, Invited Speaker: AstraZeneca. S. Ghamande: Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board, also invited speaker: GSK; Financial Interests, Institutional, Coordinating PI, Clinical trial payments: GSK, Jounce; Financial Interests, Institutional, Coordinating PI, Clinical trial payment: Merck, Eisai; Financial Interests, Institutional, Coordinating PI, clinical trial payments: Mersana, AstraZeneca; Non-Financial Interests, Advisory Role: GOG foundation. B. Ataseven: Financial Interests, Personal, Speaker, Consultant, Advisor, also support for attending meetings: AstraZeneca, GSK, Roche; Financial Interests, Personal, Speaker, Consultant, Advisor: Eisai, MSD, Novartis; Financial Interests, Personal, Advisory Board: Sanofi Aventis. D. Black: Financial Interests, Institutional, Funding: GSK; Financial Interests, Personal, Member of Board of Directors: GOG Partners Investigational Council; Financial Interests, Personal, Other: Trials365, LLC. L.J. Willmott: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Eisai, Immunogen, Merck, Seagen; Financial Interests, Personal, Advisory Board: AstraZeneca, Immunogen, Seagen. C. McCourt: Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Personal, Speaker, Consultant, Advisor: Washington University. O. Doehring, J. Garside: Financial Interests, Personal, Full or part-time Employment: GSK. T.J. Herzog: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Caris, Clovis, Eisai, Epsilogen, Genentech, GSK, Immunogen, Johnson & Johnson, Merck, Mersana, Seagen. M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, Karyopharm, Merck, Roche, Zailab; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK; Financial Interests, Personal, Member of Board of Directors: Karyopharm; Financial Interests, Personal, Stocks/Shares: Karyopharm; Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, Ultimovacs, Apexigen; Financial Interests, Institutional, Trial Chair: Deciphera; Non-Financial Interests, Advisory Role: Ultimovacs, Apexigen. All other authors have declared no conflicts of interest.

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