Table 2.
Summary of RUBY and NRG-GY018 clinical trials
| Study | RUBY | NRG-GY018 |
|---|---|---|
| Treatment | Randomized 1:1 to carboplatin AUC 5, paclitaxel 175 mg/m2, and dostarlimab 500 mg q3w for 6 cycles followed by dostarlimab 1000 mg q6w up to 3 years vs. placebo q3w for 6 cycles followed by placebo maintenance | Randomized 1:1 to carboplatin AUC 5, paclitaxel 175 mg/m2 and pembrolizumab 200 mg q3w for 6 cycles followed by pembrolizumab 400 mg q6w up to 14 cycles vs. placebo q3w for 6 cycles followed by placebo maintenance |
| Inclusion criteria |
-Primary endometrioid EC stage IIIA, IIIB, or IIIC1 with measurable disease -Primary endometrioid EC stage IIIC2 or IV regardless of measurable disease -Primary carcinosarcoma, clear-cell, serous, or mixed histologic characteristics, stage IIIC1 + regardless of measurable disease -First recurrence at least 6 months after completion of systemic chemotherapy -May have had prior EBRT |
-Primary EC Stage III—IVA with measurable disease -Primary EC Stage IVB disease with or without measurable disease -Recurrent EC with or without measurable disease -Included all histologies except carcinosarcoma -Recurrence at least 12 months after completion of systemic therapy -May have received prior pelvic radiation (EBRT/brachytherapy) a least 4 weeks prior to step 2 registration |
| Enrollment | 494 subjects were randomized from July 2019 – February 2021 | 816 subjects were randomized from July 2019—December 2022 |
| Primary Endpoints | PFS for MMRd, MSI high subjects and overall population, and OS for overall population | PFS for MMRd and MMRp subjects |
| Median Follow up | 25.4 Months of follow up in overall population | 12 months in MMRd population, 7.9 months in MMRp population |
| Results |
PFS at 24 months: -MMRd: 61% with dostarlimab vs. 15.7% with placebo. Median PFS not reached with dostarlimab vs. 7.7 months with placebo -MMRp: 28% with dostarlimab vs. 18.8% with placebo. Median PFS with dostarlimab 9.9 months vs. 7.9 months with placebo |
PFS at 12 months (MMRd), 7.9 months (MMRp): -MMRd: 74% with pembrolizumab vs. 38% with placebo. Median PFS not reached with pembrolizumab vs. 7.6 months with placebo -MMRp: 46% lower risk with pembrolizumab. Median PFS 13.1 months with pembrolizumab vs. 8.7 months with placebo |
EC endometrial cancer, MMRd mismatch repair-deficient, MMRp mismatch repair-proficient, EBRT external beam radiation therapy, MSI microsatellite instability, PFS progression free survival