Bhavana Pothuri, MD, discusses the promise of the phase 3 NRG-GY018 and RUBY trials in patients with endometrial cancer.
Bhavana Pothuri, MD, gynecologic oncologist, professor, Department of Obstetrics and Gynecology, New York University (NYU) School of Medicine, director, gynecologic oncology clincal trials, NYU Langone Health, discusses the promise of the phase 3 NRG-GY018 (NCT03914612) and RUBY (NCT03981796) trials in patients with endometrial cancer.
Updated data from both phase 3 trials were presented at the 2023 Society of Gynecologic Oncology Annual Meeting, highlighting the potential for the RUBY and NRG-GY018 trials to shift the treatment landscape. The RUBY trial evaluated the addition of the checkpoint inhibitor dostarlimab-gxly (Jemperli) to a standard chemotherapy backbone of paclitaxel and carboplatin in patients with primary advanced or recurrent endometrial cancer. The NRG-GY018 trial was a large, randomized clinical study that was statistically powered to detect a difference in progression-free survival (PFS) between patients treated with pembrolizumab (Keytruda) plus chemotherapy vs placebo plus chemotherapy.
Overall, the RUBY trial revealed that patients derived benefit from the addition of dostarlimab to the chemotherapy regimen vs placebo given with chemotherapy. In the NRG-GY018 trial, patients in the mismatch repair–deficient (dMMR) subgroup derived a clinically meaningful and statistically significant improvement in PFS with pembrolizumab.
Pothuri explains that investigators are always looking at ways to improve the outcomes of our patients with endometrial cancer. Incorporating an agent into earlier lines of therapy increases the chance of achieving a cure, she says. The data that have been seen thus far, specifically in the dMMR subgroup, point to the possibility of being able to achieve this goal, Pothuri adds.
In order to better understand how this goal may be achieved, we need long-term data are needed to show improvements for patients in overall survival (OS), Pothuri expands. Of these 2 trials, only RUBY will show OS data, because the NRG-GY018 trial was unblinded once the primary end point of PFS was met, Pothuri concludes.