Meeting
2023 ASCO Annual Meeting
Dostarlimab for primary advanced or recurrent (A/R) endometrial cancer (EC): Outcomes by blinded independent central review (BICR) of the RUBY trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).
Authors
Matthew A. Powell
National Cancer Institute sponsored NRG Oncology, Washington University School of Medicine, St Louis, MO
Matthew A. Powell , Sakari Hietanen , Robert L. Coleman , Bradley J. Monk , Oleksandr Zub , David M. O'Malley , Lucy Gilbert , Iwona Podzielinski , Roberto Angioli , Dana Meredith Chase , Dirk Bauerschlag , Destin Black , Annemarie Thijs , Sudarshan Sharma , Michael A. Gold , Kari L Ring , Zangdong He , Shadi Stevens , Brian M. Slomovitz , Mansoor R. Mirza
Organizations
National Cancer Institute sponsored NRG Oncology, Washington University School of Medicine, St Louis, MO, Turku University Hospital and FICAN West, Turku, Finland, US Oncology Research, The Woodlands, TX, Division of Gynecological Oncology, HonorHealth Research Institute, University of Arizona College of Medicine, Phoenix and Creighton University School of Medicine, Phoenix, AZ, Chernihiv Regional Oncology Hospital, Chernihiv, Ukraine, The Ohio State University and The James Cancer Center, Columbus, OH, Division of Gynecologic Oncology, McGill University Health Centre, Montreal, QC, Canada, Parkview Health, Fort Wayne, IN, University di Roma – Campus Biomedico, Rome, Italy, David Geffen School of Medicine at UCLA (affiliation at time of study Arizona Center for Cancer Care, Creighton University School of Medicine Phoenix, AZ, USA), Los Angeles, CA, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany, Department of Obstetrics and Gynecology, LSU Health Shreveport, and Willis-Knighton Physician Network, Shreveport, LA, Catharina Hospital, Eindhoven, Netherlands, Department of Obstetrics/Gynecology, AMITA Adventist Hinsdale Hospital, Hinsdale, IL, Oklahoma Cancer Specialists and Research Institute, Tulsa, OK, University of Virginia Health System, Emily Couric Clinical Cancer Center, Charlottesville, VA, GSK, Collegeville, PA, GSK, London, United Kingdom, Department of Gynecologic Oncology, Mount Sinai Medical Center, and Department of Obstetrics and Gynecology, Florida International University, Miami Beach, FL, Rigshospitalet, Copenhagen University Hospital, Copenhagen, and Nordic Society of Gynaecologic Oncology-Clinical Trial Unit, Copenhagen, Denmark
Research Funding
Pharmaceutical/Biotech Company
GSK
Background: RUBY (NCT03981796) evaluated the efficacy and safety of the anti–programmed death 1 (PD-1) dostarlimab + standard of care (SOC) carboplatin paclitaxel (CP) versus CP alone in A/R EC. The primary endpoint of PFS by investigator assessment (INV) per RECIST v1.1 was significantly longer with dostarlimab+CP than placebo (PBO)+CP in the mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H; HR 0.28; 95% CI 0.162–0.495) and overall populations (HR 0.64, 95% CI 0.507–0.800). Here we present secondary efficacy endpoints by BICR. Methods: RUBY is a phase 3, global, randomized, double-blind, multicenter, PBO-controlled study. Patients (pts) with primary advanced stage III or IV or first recurrent EC were randomized 1:1 to receive dostarlimab 500 mg, or PBO, plus carboplatin AUC 5 and paclitaxel 175 mg/m2 Q3W (6 cycles), followed by dostarlimab 1000 mg, or PBO, monotherapy Q6W for up to 3 y. Secondary endpoints by BICR assessment per RECIST v1.1 were PFS, ORR, DOR, and DCR in the overall and dMMR/MSI-H populations. Results: 494 pts were randomized (245:dostarlimab+CP; 249:PBO+CP); 47.8% had recurrent disease, 18.6% and 33.6% had primary stage III and IV disease, respectively. PFS by BICR was longer with dostarlimab+CP than PBO+CP in the dMMR/MSI-H (HR 0.29; 95% CI 0.158–0.543) and overall populations (HR 0.66; 95% CI 0.517–0.853; Table). Consistent benefits were seen with dostarlimab+CP for ORR, DCR, and DOR by BICR in the dMMR/MSI-H and overall populations (Table). Safety was previously reported. Conclusions: Dostarlimab+CP showed clinically meaningful improvement in BICR-assessed PFS in the dMMR/MSI-H and overall populations compared with CP alone. The HRs for PFS per BICR and per INV were consistent, which supports the reliability of PFS by INV in EC trials. Benefits were seen in all BICR-assessed endpoints, which were consistent with INV. Dostarlimab+CP represents a new SOC for pts with primary A/R EC. Clinical trial information: NCT03981796.
| dMMR/MSI-H | Overall | |||
|---|---|---|---|---|
| Dostarlimab +CP N=53 | PBO+CP N=65 | Dostarlimab +CP N=245 | PBO+CP N=249 | |
| PFS by INV, HR (95% CI) | 0.28 (0.162–0.495) P<0.0001 | 0.64 (0.507–0.800) P<0.0001 | ||
| PFS by BICR, HR (95% CI) | 0.29 (0.158–0.543) | 0.66 (0.517–0.853) | ||
| Probability of PFS by BICR at 24 mo, % (95% CI) | 66.3 (50.8–77.9) | 26.0 (13.5–40.5) | 42.5 (35.2–49.6) | 25.4 (18.9–32.4) |
| ORR by BICR, % (95% CI; n/N)a CR, % (n) PR, % (n) | 77.1 (62.7–88.0; 37/48) 22.9 (11) 54.2 (26) | 63.3 (49.9–75.4; 38/60) 13.3 (8) 50.0 (30) | 68.2 (61.6–74.2; 152/223) 20.6 (46) 47.5 (106) | 59.4 (52.7–65.8; 136/229) 14.8 (34) 44.5 (102) |
| DCR, % (95% CI; n/N)a | 91.7 (80.0–97.7; 44/48) | 91.7 (81.6–97.2; 55/60) | 88.3 (83.4–92.2; 197/223) | 86.9 (81.8–91.0; 199/229) |
| mDOR (95% CI), moa | NE (13.1–NE) | 6.9 (5.5–10.1) | 12.9 (8.2–NE) | 6.7 (5.7–8.3) |
aAssessed in pts with evaluable disease at baseline.
CR, complete response; PR, partial response; NE, not estimable. *no MRI done.
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Abstract Details
Session Type
Oral Abstract Session
Session Title
Gynecologic Cancer
Track
Gynecologic Cancer
Sub Track
Uterine Cancer
Clinical Trial Registration Number
NCT03981796
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 5503)
DOI
10.1200/JCO.2023.41.16_suppl.5503
Abstract #
5503
Abstract Disclosures
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