The phase 3 RUBY trial (NCT03981796) revealed that treatment with dostarlimab-gxly combined with carboplatin/paclitaxel, followed by maintenance dostarlimab and niraparib, offers a progression-free survival (PFS) benefit in patients with primary advanced or recurrent endometrial cancer. This trial met its primary endpoint, showing significant improvement in PFS with the dostarlimab combination, compared with placebo and chemotherapy, in both the general patient population and a specific subgroup with mismatch repair proficient/microsatellite stable disease.
The RUBY trial’s secondary endpoints include OS, overall response rate, duration of response, disease control rate, patient-reported outcomes, and PFS2. Preliminary data from the trial showed promising PFS rates in various patient subgroups. The trial enrolled 787 patients with specific eligibility criteria, including a diagnosis of advanced or recurrent endometrial cancer, stage III to IV disease or first recurrence, and an ECOG performance status of 0 or 1.
Reference: Virgil H. Dostarlimab/Niraparib Improves PFS Outcomes in Advanced Endometrial Cancer. Cancer Network. Published December 20, 2023. Accessed February 2, 2024. https://www.cancernetwork.com/view/dostarlimab-niraparib-improves-pfs-outcomes-in-advanced-endometrial-cancer
