RUBY, 2023

Question 1

What is the study question of RUBY trial?

Answer 1

The GARNET trial approved dostarlimab for dMMR-MSI-H adv or recurrent endometrial ca (EU) and dMMR solid tumors (US); also data for pMMR and MSS tumors - cytotoxic chemo can produce immunomodulatory effects - chemo and IO can be synergistic

Question 2

What was the study design of RUBY?

Answer 2

RCT, carbo/taxol/dostarlimab vs carbo/taxol/placebo

Question 3

Inclusion criteria for RUBY?

Answer 3

3A-C with measurable disease
3C1 with high risk histology
3C2
4 - regardless of measurable disease
Recurrent with TFI 6+ mo; carcinosarcoma included (capped at 10%)

Question 4

What were the results of the RUBY trial?

Answer 4

At 2 yr follow up:
PFS/dMMR: 61.4 vs. 15.7% (for pMMR 28 vs 19% PFS)
OS/dMMR - 83 vs 58% (for pMMR, OS trended towards improvement)

PFS/all: 36.1 vs. 18.1%

OS/all: 71.3 vs. 56.0%