RUBY / ENGOT-EN6-NSGO
Does adding dostarlimab to carboplatin-paclitaxel and continuing maintenance improve outcomes in advanced/recurrent endometrial cancer?
Trial design and population
Population: 494 patients with primary advanced stage III/IV or first recurrent endometrial cancer.
Treatment vs comparator: Dostarlimab 500 mg IV every 3 weeks with carboplatin AUC 5/paclitaxel 175 mg/m² for 6 cycles, then dostarlimab 1000 mg every 6 weeks vs placebo.
Registry: NCT03981796
Key results
Second interim OS HR 0.69 (95% CI 0.54–0.89; p=0.002) overall; dMMR/MSI-H OS HR 0.32 (95% CI 0.17–0.63). Initial 24-month PFS 36.1% vs 18.1% overall (HR 0.64); dMMR/MSI-H 61.4% vs 15.7% (HR 0.28).
24-month PFS, all patients · Initial analysis
Bars are scaled to the larger reported value. Median survival differences are not NNTs.
Absolute effect
Endpoint/time horizon: 24-month PFS, all patients · Initial analysis. NNT is not calculated from median survival or hazard ratios; use fixed-time absolute risks only. NNH not calculated without a defensible fixed-time excess-harm risk difference.
Safety, treatment burden and QoL
Cytopenias, neuropathy and alopecia; immune-mediated endocrinopathies, colitis, hepatitis and pneumonitis require monitoring. Maintenance extends treatment burden.
Quality-of-life and discontinuation percentages are not asserted without full source-table verification; source-level QoL/toxicity audit remains a QC item.
Subgroups, maturity and limitations
Keep initial PFS and later OS analysis cutoffs distinct. The dMMR/MSI-H subgroup effect is larger than the overall effect; check later follow-up before clinical-currency signoff.
Distinguish prespecified from exploratory subgroup analyses and mature from immature endpoints. Verify current guideline context before applying historical trial findings.
Current-practice context · 21 October 2026
Confirm current guidelines, regulatory status, biomarkers, prior treatment, comorbidities and patient goals. Full clinical freshness and source-level QoL audit remain pending.