749P - Patient-reported outcomes (PROs) in patients (pts) with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (pA/rEC) in the ENGOT-EN6-NSGO/GOG3031/RUBY trial

Background

In the RUBY (NCT03981796) trial, dostarlimab (D)+carboplatin/paclitaxel (CP) demonstrated significant PFS improvement compared to placebo (PBO)+CP in pts with pA/rEC. PROs are reported here for the dMMR/MSI-H population.

Methods

Pts with pA/rEC were randomized 1:1 to D+CP or PBO+CP Q3W (6 cycles) followed by D or PBO monotherapy Q6W ≤3 years or disease progression. EORTC QLQ-C30 and EORTC QLQ-EN24 were secondary endpoints. PROs were administered at baseline (BL), day 1 of each cycle (C), end of treatment (EOT), and all follow-ups. Change (chg) from BL to EOT was calculated for assessed scales. Mixed models for repeated measures were used to generate least-squares means (LSM), adjusting for within-pt correlations across time points within a pt and controlling for BL values. Improvement is indicated by higher scores for QoL and functional scales and lower scores for symptom scales.

Results

Of 494 pts enrolled, 118 were dMMR/MSI-H. Mean BL scores and mean chg from BL to EOT for global QoL, functional scales, and select symptom are shown in the table. Mean chg from BL to EOT showed improvement in global QoL, emotional and social function, pain, and back/pelvis pain for D+CP. Only back/pelvis pain showed improvement for PBO+CP. Significant differences (LSM [standard error]) between arms were reported for chg from BL to EOT for QoL (14.7 [5.45]; P=0.008), role (12.7 [5.92]; P=0.032), emotional (14.3 [4.92]; P=0.004) and social function (13.5 [5.43]; P=0.014), and fatigue (-13.3 [5.84]; P=0.025).

Conclusions

Pts receiving D+CP demonstrated improvements in several QoL domains relative to BL at EOT, with significant improvements over PBO+CP, in global QoL, role, emotional, and social function, and fatigue. Dostarlimab+CP significantly improved PFS while maintaining QoL, further supporting its use as a standard of care in pts with dMMR/MSI-H pA/rEC. Table: 749P

^aLower scores indicate reduced symptom severity F, function

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

G. Valabrega: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, Clovis Oncology, GSK, PharmaMar, Roche, Tesaro. M.A. Powell: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK, Tesaro, Merck, Eisai, Clovis Oncology, AstraZeneca. S. Hietanen: Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Orion Pharma; Financial Interests, Personal, Expert Testimony: AstraZeneca, GSK. E.M. Miller: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, GSK, Tempus; Financial Interests, Personal, Other: OncLive, Opinions in Gyn Malignancies. Z. Novák: Financial Interests, Personal, Speaker, Consultant, Advisor: Sofmedica, AstraZeneca, MSD, Preglem; Financial Interests, Personal, Advisory Board: Richter Gedeon; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Stocks/Shares: Richter Gedeon. R. Holloway: Financial Interests, Personal, Other: GSK, AstraZeneca, Clovis, Eisai, Merck; Financial Interests, Personal, Stocks or ownership: Genelux. D. Denschlag: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, GSK/Tesaro, Roche, Eisai Germany, MSD Oncology, MSD, Intuitive Surgical, KLS Martin; Financial Interests, Personal, Other, travel expenses: AstraZeneca; Financial Interests, Personal, Other: Roche. T. Myers: Financial Interests, Personal, Other: Immunogen. A.M. Thijs: Financial Interests, Institutional, Funding: Alkermes, AstraZeneca, Clovis, Esperas, IMV, ImmunoGen Inc., Karyopharm, Merck Sharp & Dohme, Mersana, Novocure GmbH, OncoQuest Pharmaceuticals, Pfizer, Roche, and Tesaro; Financial Interests, Personal, Speaker, Consultant, Advisor: Merck; Financial Interests, Personal, Other: Alkermes, AstraZeneca, Eisai, Eisai-Merck, and GSK. 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, AstraZeneca, Eisai, Eisai-Merck, GSK; Financial Interests, Personal, Other: Alkermes. L. Copeland: Financial Interests, Institutional, Funding: AbbVie, Advaxis, Agenus, Ajinomoto, Arcus Biosciences Inc., Array BioPharm, AstraZeneca, BeiGene USA Inc., BMS, Cerulean Pharma, Clovis Oncology, Deciphera Pharma, Eisai, EMD Serano, Ergomed Clinical Research, Exelixis, Genetech/Roache, Genmab, GSK, Hoffmann-LaRoche, Immunogen, Leap Therapeutics, Ludwig Institute of Pharmaceuticals, Merck, Mersana Therapeutics, Novocure, OncoQuest, PharmaMar USA, Pfizer, PRA International, Precision Therapeutics, Regeneron, Sanofi, Seattle Genetics, Serono, Stemcentrix, Sumitomo Dainippon Pharma Oncology, Sutro Biopharm, Tesaro (GSK), TRACON Pharm, Verastem; Financial Interests, Personal, Advisory Board: A28 Therapeutics, Celsion Corporation, Corcept Therapeutics, Elevar Therapeutics, GSK, Immunogen, Inx Med, Luzsana Biotechnology, Myriad Genetics, OncoNova, Rubius Therapeutics, Sorrento Therapeutics, Toray Industries, Inc., VBL Therapeutics; Financial Interests, Personal, Member: DMCC for Corcept Therapeutics. R. Gogoi: Financial Interests, Personal, Advisory Board: Pionyr Pharmaceuticals; Financial Interests, Personal, Other: Bausch + Lomb. N. Cloven: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, Toray Pharmaceuticals. O. Meyers, J. Garside: Financial Interests, Personal, Full or part-time Employment: GSK. 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. D. Black: Financial Interests, Institutional, Funding: GSK; Financial Interests, Personal, Membership or affiliation: GOG Partners Investigational Council; Financial Interests, Personal, Ownership Interest: Trials365, LLC. All other authors have declared no conflicts of interest.