Matthew A. Powell, MD, discusses the methods and design of the randomized, double-blind, phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO trial in endometrial cancer.
Matthew A. Powell, MD, a professor of obstetrics and gynecology, chief of the division of gynecologic oncology at Washington University School of Medicine, and gynecologic oncologist at Siteman Cancer Center, discusses the methods and design of the phase 3, randomized, double-blind RUBY/ENGOT-EN6/GOG3031/NSGO trial (NCT03981796) of dostarlimab-gxly (Jemperli) in combination with standard-of-care chemotherapy followed by dostarlimab plus niraparib (Zejula) as maintenance therapy in adult patients with primary advanced or recurrent endometrial cancer.
Those enrolled in the study had primary advanced or recurrent endometrial cancer that was mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H).
The dual primary end points of part 1 of the study were investigator-assessed progression-free survival (PFS) based on the RECISTv1.1 and overall survival (OS). In part 2, the primary end point was investigator-assessed PFS in the overall population. PFS in the MMRp/MSS population, and OS in the overall population were additional end points, and for both parts of the trial, investigators assessed PFS per blinded independent central review, overall response rate, duration of response, disease control rate, patient-reported outcomes, safety, and tolerability.
0:09 | We're providing further data on the RUBY trial, which is dostarlimab plus carboplatin and paclitaxel chemotherapy versus placebo and carboplatin/paclitaxel chemotherapy. This has led to transformative results, especially in the dMMR population, and…led to publication in the New England Journal of Medicine, and now is NCCN Compendium-listed as an option for our patients with advanced or recurrent endometrial cancer.
0:42 | The study we presented at ASCO has to do with some additional end points or secondary end points of the BICR for the patients enrolled on the trial. It's important to not only evaluate the investigator assessment, which was our primary outcome of the trial, for both PFS and OS, but look at this in an independent subset of patients who underwent a BICR assessment. This was important not only to investigate possible bias among the investigators, but also to understand [since] those end points are important for regulatory purposes.