Pembrolizumab regimen extends PFS in advanced, recurrent endometrial carcinoma
The addition of pembrolizumab to chemotherapy significantly extended PFS as first-line treatment for advanced or recurrent endometrial carcinoma, according to the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, also exhibited a safety profile consistent with prior studies, with no new safety signals.
“Patients with advanced-stage or recurrent endometrial cancer, the most common type of gynecologic cancer in the U.S., face a poor prognosis with limited treatment options. This is particularly notable in patients who progress after prior platinum-based adjuvant therapy with disease not amenable to curative surgery or radiation,” Ramez Eskander, MD, principal investigator and gynecologic oncologist at the University of California, San Diego, said in a Merck press release.
The randomized phase 3 NRG-GY018 trial assessed the efficacy of pembrolizumab plus standard of care chemotherapy — carboplatin and paclitaxel —for women with previously untreated stage III to stage IV or recurrent endometrial carcinoma.
Researchers randomly assigned 819 women to receive either pembrolizumab and chemotherapy every 3 weeks for approximately six cycles followed by pembrolizumab as a single agent every 6 weeks for 14 cycles, or placebo plus chemotherapy. The study included two independent cohorts of women: those with mismatch repair-proficient or mismatch repair-deficient disease.
Results at a prespecified interim analysis showed a statistically significant and clinically meaningful improvement in PFS — the study’s primary endpoint — with the pembrolizumab regimen in both study cohorts.
The data will be presented at a future medical meeting.