RUBY — Dostarlimab Plus Carboplatin-Paclitaxel in Primary Advanced or Recurrent Endometrial Cancer (RUBY)

Phase 3 · 2023 · Endometrial Cancer

Design

Randomized double-blind trial of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab maintenance versus chemotherapy plus placebo.

Population

Primary advanced (stage III/IV) or first recurrent endometrial cancer.

Primary Endpoint

progression-free survival (overall and dMMR/MSI-H populations)

Key Result

In dMMR/MSI-H disease, 24-month PFS 61.4% vs 15.7% (HR 0.28); overall-population PFS also improved (HR 0.64), with an overall-survival benefit reported.

Guideline Impact

NCCN category 1 dostarlimab plus chemotherapy for primary advanced/recurrent endometrial cancer (preferred in dMMR/MSI-H)