37MO Dostarlimab plus chemotherapy in primary advanced or recurrent endometrial cancer (pA/rEC) in the RUBY trial: Overall survival (OS) by MMR status and molecular subgroups
Bibliographic record
Abstract
At interim analysis (IA) 1 of Part 1 of the RUBY trial (NCT03981796), statistically significant benefit in PFS was observed with dostarlimab+carboplatin-paclitaxel (D+CP) vs placebo (PBO)+CP in the overall and mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) populations of pts with pA/rEC. Here we report OS from IA2. Pts with pA/rEC were randomized 1:1 to D+CP or PBO+CP followed by D or PBO for ≤3 years or until progression. OS was a dual-primary endpoint in the overall population and a prespecified, exploratory analysis in the dMMR/MSI-H and mismatch repair proficient/microsatellite stable (MMRp/MSS) populations. OS by molecular subgroup was a post-hoc analysis. Safety was a secondary endpoint. 494 pts were randomized (245 D+CP; 249 PBO+CP). In the overall population, there was a significant reduction in the risk of death by 31% and clinically meaningful improvement of 16.4 mo in median OS (mOS) for D+CP vs PBO+CP (Table). In the dMMR/MSI-H population, hazard ratio (HR) for OS was 0.32; mOS was not reached for D+CP and was 31.4 mo for PBO+CP. In the MMRp/MSS population, HR for OS was 0.79; mOS was 34.0 mo for D+CP and 27.0 mo for PBO+CP. At IA2, in 400 pts with whole exome sequencing, a trend towards clinical benefit with D+CP was observed in the dMMR/MSI-H, TP53 mutated, and no specific molecular profile subgroups. Table: 37MOSafety at IA2 was similar to IA1Dostarlimab+CPPlacebo+CPOS, HR (95% CI)Overall, N2452490.69 (0.54–0.89)P=0.002OS, median (95% CI), mo44.6 (32.6–NR)28.2 (22.1–35.6)–dMMR/MSI-H, n53650.32 (0.17–0.63)OS, median (95% CI), moNR (NR–NR)31.4 (20.3–NR)–MMRp/MSS, n1921840.79 (0.60–1.04)OS, median (95% CI), mo34.0 (28.6–NR)27.0 (21.5–35.6)–Post hoc exploratory molecular subgroup analysis of OSaPOLEmut, n23No events in either armdMMR/MSI-H, n39520.40 (0.19–0.83)TP53mut, n47410.59 (0.33–1.03)NSMP, n1031130.89 (0.61–1.29)aAnalyses were conducted in 400 patients with whole exome sequencing results. Mut, mutant; NR, not reached; NSMP, no specific molecular profile. Open table in a new tab aAnalyses were conducted in 400 patients with whole exome sequencing results. Mut, mutant; NR, not reached; NSMP, no specific molecular profile. D+CP showed statistically significant and clinically relevant OS benefit in the overall population compared with CP alone. A substantial survival difference was seen in the dMMR/MSI-H population. In the MMRp/MSS population, there was a 7 mo difference in median OS vs CP alone, with a 21% risk reduction for death. OS by molecular subgroup at IA2 was consistent with IA1. RUBY is the only trial to demonstrate a statistically significant OS benefit in pts with pA/rEC and supports the use of dostarlimab+CP as a standard of care in the 1L setting.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".