Taken together, the studies point to meaningful changes in the standard of care for patients with advanced or recurrent endometrial cancer.
Results from 2 clinical trials, presented at the Society of Gynecologic Oncology 2023 Annual Meeting on Women’s Cancer, demonstrated that adding immunotherapy to standard chemotherapy resulted in significantly longer progression-free survival (PFS) among patients with advanced or recurrent endometrial cancer.
The first trial presented, NRG-GY018, involved 816 patients with stage 3/4A, 4B, or recurrent endometrial cancer. Participants were randomized 1-to-1 to receive either immunotherapy pembrolizumab plus chemotherapy or placebo plus chemotherapy across 6 cycles, followed by up to 14 cycles of maintenance pembrolizumab or placebo. Importantly, patients in the mismatch repair-proficient endometrial cancer cohort who received immunotherapy and chemotherapy experienced PFS for 11.7 months versus 8.7 months among those receiving chemotherapy alone, with managed adverse effects (AEs).
The second trial, ENGOT-EN6-NSGO/GOG-3031/RUBY, included 494 eligible patients with first recurrent or primary advanced stage 3 or 4 endometrial cancer. Participants were randomized 1-to-1 to receive either immunotherapy dostarlimab plus chemotherapy followed by monotherapy or placebo plus chemotherapy, then monotherapy.
Among the 245 patients who received both immunotherapy and chemotherapy in the RUBY trial, there were statistically significant and clinically meaningful PFS benefits across all populations compared with 249 patients treated with chemotherapy alone. Additionally, investigators observed an early trend toward improved overall survival in all populations.
“Patients with advanced stage or recurrent endometrial cancer, the most common type of gynecologic cancer in the United States, face a poor prognosis with limited treatment options,” said NRG-GY018 trial investigator Ramez N. Eskander, MD, in a press release. “This is particularly notable in patients who progress after platinum-based adjuvant therapy with disease not amenable to curative surgery or radiation. In the GY-018 study, we saw clinically meaningful improvement in PFS in both study populations—an encouraging new finding. Future analysis will examine overall survival and quality of life outcomes.”
Two Clinical Trials Reveal Addition of Immunotherapy to Chemotherapy Regimen Increases Progression-Free Survival in Endometrial Cancer Patients. News release. Society of Gynecologic Oncology. March 27, 2023. Accessed April 6, 2023.