{"id":28734,"date":"2023-03-27T16:30:00","date_gmt":"2023-03-27T16:30:00","guid":{"rendered":"http:\/\/267fa1a06699b10f4767cd5b0b43f330"},"modified":"2024-11-03T15:12:49","modified_gmt":"2024-11-03T15:12:49","slug":"latest-data-indicate-new-care-standard-in-advanced-recurrent-endometrial-cancer-results-from-the-ruby-trial-esmo-press-release","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/latest-data-indicate-new-care-standard-in-advanced-recurrent-endometrial-cancer-results-from-the-ruby-trial-esmo-press-release\/","title":{"rendered":"Latest Data Indicate New Care Standard in Advanced\/Recurrent Endometrial Cancer: Results from the RUBY Trial [ESMO Press Release]"},"content":{"rendered":"

VP2-2023 – Dostarlimab+chemotherapy for the treatment of primary advanced or recurrent (A\/R) endometrial cancer (EC): A placebo (PBO)-controlled randomised phase III trial (ENGOT-EN6-NSGO\/GOG-3031\/RUBY)<\/p>\n

\n

M.R. Mirza1<\/sup>, D. Chase2<\/sup>, B.M. Slomovitz3<\/sup>, R.D. Christensen4<\/sup>, Z. Nov\u00e1k5<\/sup>, D. Black6<\/sup>, L. Gilbert7<\/sup>, S. Sharma8<\/sup>, G. Valabrega9<\/sup>, L.M. Landrum10<\/sup>, L.C. Hanker11<\/sup>, A. Stuckey12<\/sup>, I.A. Boere13<\/sup>, M. Gold14<\/sup>, S.E. Gill15<\/sup>, B.J. Monk16<\/sup>, Z. He17<\/sup>, S. Stevens18<\/sup>, R.L. Coleman19<\/sup>, M.A. Powell20<\/sup> 
1<\/sup>Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, and Nordic Society of Gynaecologic Oncology-Clinical Trial Unit, Copenhagen, Denmark;\u202f2<\/sup>Affiliation at time of study: Arizona Center for Cancer Care, Creighton University School of Medicine Phoenix, AZ, USA, Current affiliation: Division of Gynecologic Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 3<\/sup>Department of Gynecologic Oncology, Mount Sinai Medical Center, and Department of Obstetrics and Gynecology, Florida International University, Miami Beach, FL, USA;\u202f4<\/sup>Research Unit for General Practice, University of Southern Denmark, Institute of Public Health, Odense, Denmark;\u202f5<\/sup>Department of Gynecology, Hungarian National Institute of Oncology, Budapest, Hungary;\u202f6<\/sup>Department of Obstetrics and Gynecology, LSU Health Shreveport and Willis-Knighton Physician Network, Shreveport, LA, USA;\u202f7<\/sup>Division of Gynecologic Oncology, McGill University Health Centre, Montreal, QC, Canada;\u202f8<\/sup>Department of Obstetrics\/Gynecology, AMITA Adventist Hinsdale Hospital, Hinsdale, IL, USA;\u202f9<\/sup>Department of Oncology, University of Torino, AO Ordine Mauriziano, Turin, Italy;\u202f10<\/sup>Department of Oncology, Indiana University Health and Simon Cancer Center, Indianapolis, IN, USA;\u202f11<\/sup>Department of Gynecology and Obstetrics, University Hospital Schleswig-Holstein, Campus L\u00fcbeck, L\u00fcbeck, Germany;\u202f12<\/sup>Department of Oncology, Women and Infants Hospital, Providence, RI, USA;\u202f13<\/sup>Department of Medical Oncology, Erasmus MC Cancer Centre, Rotterdam, Netherlands;\u202f14<\/sup>Department of Oncology, Oklahoma Cancer Specialists and Research Institute, Tulsa, OK, USA;\u202f15<\/sup>Division of Gynecologic Oncology, Nancy N and JC Lewis Cancer and Research Pavilion, Savannah, GA, USA;\u202f16<\/sup>Department of Gynecologic Oncology, HonorHealth Research Institute, University of Arizona College of Medicine, Phoenix, and Creighton University School of Medicine, Phoenix, AZ, USA;\u202f17<\/sup>Department of Clinical Statistics, GSK, Philadelphia, PA, USA;\u202f18<\/sup>Department of Clinical Development, GSK, London, UK;\u202f19<\/sup>Department of Gynecologic Oncology, US Oncology Research, The Woodlands, TX, USA;\u202f20<\/sup>Department of Gynecologic Oncology, National Cancer Institute sponsored NRG Oncology, Washington University School of Medicine, St. Louis, MO, USA <\/p>\n

Background:<\/strong>\u202f<\/strong>Carboplatin-paclitaxel (CP) is standard of care (SOC) for first-line treatment of primary A\/R EC; median OS is <3 yrs. Use of anti\u2013PD-1s with chemo has improved outcomes in multiple tumour types. RUBY (NCT03981796) evaluated the efficacy and safety of the anti\u2013PD-1 dostarlimab (D)+CP in A\/R EC compared with CP alone. <\/p>\n

Methods:<\/strong>\u202f<\/strong>RUBY is a phase III, global, randomised, double-blind, multicentre, PBO-controlled study. Pts with primary advanced stage III or IV or first recurrent EC were randomised 1:1 to receive dostarlimab 500 mg, or PBO, plus carboplatin AUC 5 and paclitaxel 175 mg\/m2<\/sup>\u202fQ3W (6 cycles), followed by dostarlimab 1000 mg, or PBO, monotherapy Q6W for up to 3 yrs. Primary endpoints were PFS by investigator assessment per RECIST v1.1 and OS. Graphical method was used for hypothesis testing of PFS in the dMMR\/MSI-H population, then the overall population, and OS in the overall population. A prespecified exploratory analysis of PFS in MMR proficient (MMRp)\/MS stable (MSS) pts was also performed. Safety was assessed. <\/p>\n

Results:<\/strong>\u202f<\/strong>Of 494 pts randomised (245 D+CP; 249 PBO+CP), 23.9% had dMMR\/MSI-H tumours (53 D+CP; 65 PBO+CP), 47.8% had recurrent disease; 18.6% and 33.6% had primary stage III and IV disease, respectively. PFS and OS results are presented in the table. Discontinuation of dostarlimab or PBO due to a TEAE occurred in 17.4% pts receiving D+CP and 9.3% pts receiving PBO+CP. The safety profile of D+CP was generally consistent with the safety profile of each drug. <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\n\n

 <\/p>\n<\/td>\n

\n

HR<\/strong> 
(95% CI)<\/strong> 
P<\/em><\/strong> <\/p>\n<\/td>\n

\n

% Probability at 24 mo<\/strong> 
(95% CI)<\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

PFS<\/strong> <\/p>\n<\/td>\n

\n

dMMR\/MSI-H<\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

D+CP <\/p>\n<\/td>\n

\n

0.28 
(0.162\u20130.495) 
<0.0001 <\/p>\n<\/td>\n

\n

61.4 
(46.3\u201373.4) <\/p>\n<\/td>\n<\/tr>\n

\n

PBO+CP <\/p>\n<\/td>\n

\n

15.7 
(7.2\u201327.0) <\/p>\n<\/td>\n<\/tr>\n

\n

Overall<\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

D+CP <\/p>\n<\/td>\n

\n

0.64 
(0.507\u20130.800) 
<0.0001 <\/p>\n<\/td>\n

\n

36.1 
(29.3\u201342.9) <\/p>\n<\/td>\n<\/tr>\n

\n

PBO+CP <\/p>\n<\/td>\n

\n

18.1 
(13.0\u201323.9) <\/p>\n<\/td>\n<\/tr>\n

\n

MMRp\/MSS<\/strong>a<\/sup><\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

D+CP <\/p>\n<\/td>\n

\n

0.76 
(0.592\u20130.981) 
NA <\/p>\n<\/td>\n

\n

28.4 
(21.2\u201336.0) <\/p>\n<\/td>\n<\/tr>\n

\n

PBO+CP <\/p>\n<\/td>\n

\n

18.8 
(12.8\u201325.7) <\/p>\n<\/td>\n<\/tr>\n

\n

OS<\/strong> <\/p>\n<\/td>\n

\n

Overall<\/strong>b<\/sup><\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

D+CP <\/p>\n<\/td>\n

\n

0.64 
(0.464\u20130.870) 
0.0021e<\/sup> <\/p>\n<\/td>\n

\n

71.3 
(64.5\u201377.1) <\/p>\n<\/td>\n<\/tr>\n

\n

PBO+CP <\/p>\n<\/td>\n

\n

56.0 
(48.9\u201362.5) <\/p>\n<\/td>\n<\/tr>\n

\n

dMMR\/MSI-H<\/strong>c<\/sup><\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

D+CP <\/p>\n<\/td>\n

\n

0.30 
(0.127\u20130.699) 
NA <\/p>\n<\/td>\n

\n

83.3 
(66.8\u201392.0) <\/p>\n<\/td>\n<\/tr>\n

\n

PBO+CP <\/p>\n<\/td>\n

\n

58.7 
(43.4\u201371.2) <\/p>\n<\/td>\n<\/tr>\n

\n

MMRp\/MSS<\/strong>d<\/sup><\/strong> <\/p>\n<\/td>\n<\/tr>\n

\n

D+CP <\/p>\n<\/td>\n

\n

0.73 
(0.515\u20131.024) 
NA <\/p>\n<\/td>\n

\n

67.7 
(59.8\u201374.4) <\/p>\n<\/td>\n<\/tr>\n

\n

PBO+CP <\/p>\n<\/td>\n

\n

55.1 
(46.8\u201362.5) <\/p>\n<\/td>\n<\/tr>\n

\n

a<\/sup>No hypothesis testing of PFS in MMRp\/MSS was planned. Maturity:\u202fb<\/sup>\u224833%,\u202fc<\/sup>\u224826%,\u202fd<\/sup>\u224836%.\u202fe<\/sup>P<\/em>-value \u22640.00177 required for statistical significance at this analysis <\/p>\n<\/td>\n<\/tr>\n<\/table>\n

Conclusions:<\/strong>\u202f<\/strong>D+CP showed statistically significant and clinically meaningful PFS benefits in the dMMR\/MSI-H and overall populations vs CP alone. A clinically relevant benefit in PFS was also observed in the MMRp\/MSS population. An early trend toward improved OS was observed in all populations. The combination of dostarlimab+CP represents a new SOC for pts with newly diagnosed primary A\/R EC. <\/p>\n

Clinical trial identification:<\/strong>\u202f<\/strong>NCT03981796. <\/p>\n

Editorial acknowledgement:<\/strong>\u202f<\/strong>Writing and editorial support, funded and coordinated by GSK (Waltham, MA, USA), was provided by Shannon Morgan-Pelosi, PhD, and Dena McWain of Ashfield MedComms, an Inizio company. <\/p>\n

Legal entity responsible for the study:<\/strong>\u202f<\/strong>GSK. <\/p>\n

Funding:<\/strong>\u202f<\/strong>GSK. <\/p>\n

Disclosure: <\/strong>M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zailab; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, Karyopharm; Financial Interests, Personal, Stocks\/Shares: Karyopharm; Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, Ultimovacs, Apexigen; Financial Interests, Institutional, Invited Speaker: Deciphera; Non-Financial Interests, Personal, Advisory Role: Ultimovacs, Apexigen. 
D. Chase: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, Clovis, Genentech\/Roche; Financial Interests, Personal, Advisory Role: GSK, AstraZeneca, Clovis, Genentech\/Roche. 
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, Personal, Invited Speaker: GOG Foundation. 
R.D. Christensen: Financial Interests, Personal, Advisory Role: Nordic Society for Gynecologic Oncology, Karyopharm; Financial Interests, Personal, Advisory Board: Swiss GO Trial Group; Financial Interests, Personal, Stocks\/Shares: Y-mAbs Therapeutics. 
Z. Nov\u00e1k: Financial Interests, Personal, Advisory Board: Sofmedica, AstraZeneca, MSD, Richter Gedeon; Financial Interests, Personal, Other: Sofmedica, Preglem, AstraZeneca; Financial Interests, Personal, Officer: Hungarian Society of Gynecologic Oncology; Financial Interests, Personal, Stocks\/Shares: Richter Gedeon. 
D. Black: Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Personal, Member of the Board of Directors: GOG Partners Investigational Council. 
L. Gilbert: Financial Interests, Institutional, Research Grant: Alkermes, AstraZeneca, Clovis, Esperas, IMV, ImmunoGen Inc, Karyopharm, Merck Sharp & Dohme, Mersana, Novocure GmbH, OncoQuest Pharmaceuticals, Pfizer, Roche, Tesaro; Financial Interests, Personal, Advisory Role: Merck, Alkermes, AstraZeneca, Eisai, Eisai-Merck, GSK. 
G. Valabrega: Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Clovis Oncology, GSK, PharmaMar, Roche, Tesaro. 
L.C. Hanker: Financial Interests, Personal, Advisory Board: Amgen, Roche, GSK, MSD, AstraZeneca. 
A. Stuckey: Financial Interests, Personal, Other: UptoDate. 
I.A. Boere: Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Institutional, Advisory Board: AstraZeneca, GSK. 
B.J. Monk: Financial Interests, Personal, Advisory Role: VBL, US Oncology Research, Sorrento, Regeneron, Pfizer, Myriad, Novocure, Novartis, Mersana, MacroGenics, Iovance, Karyopharm, ImmunoGen, Gradalis, GOG Foundation, Genmab\/Seagen, EMD Merck, Elevar, Bayer, Aravive, Amgen, Akeso Bio, Agenus; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Speaker\u2019s Bureau: Tesaro\/GSK, Roche\/Genentech, Merck, Easai, Clovis, AstraZeneca. 
Z. He: Financial Interests, Personal, Full or part-time Employment: GSK. 
S. Stevens: Financial Interests, Personal, Full or part-time Employment: GSK. 
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, Personal, Principal Investigator: AbbVie, ImmunoGen, Roche\/Genentech, Merck, Genmab, Clovis; Non-Financial Interests, Personal, Project Lead, MyLung Consortium: US Oncology Research. 
M.A. Powell: Financial Interests, Personal, Advisory Role: GSK, Tesaro, Merck, Eisai, SeaGen, Clovis Oncology, AstraZeneca. 
All other authors have declared no conflicts of interest. <\/p>\n<\/p><\/div>\n

Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"

VP2-2023 – Dostarlimab+chemotherapy for the treatment of primary advanced or recurrent (A\/R) endometrial cancer (EC): A placebo (PBO)-controlled randomised phase III trial (ENGOT-EN6-NSGO\/GOG-3031\/RUBY) M.R. Mirza1, D. Chase2, B.M. Slomovitz3, R.D. Christensen4, Z. Nov\u00e1k5, D. Black6, L. Gilbert7, S. Sharma8, G. Valabrega9, L.M. Landrum10, L.C. Hanker11, A. Stuckey12, I.A. Boere13, M. Gold14, S.E. Gill15, B.J. Monk16, […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-28734","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/28734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=28734"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/28734\/revisions"}],"predecessor-version":[{"id":43011,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/28734\/revisions\/43011"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=28734"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=28734"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=28734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}