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Ramez N. Eskander, MD, discusses findings from the phase 3 NRG GY018 trial of pembrolizumab plus chemotherapy in patients with endometrial cancer.
Ramez N. Eskander, MD, associate professor, Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Services, University of California San Diego Moores Cancer Center, discusses findings from the phase 3 NRG GY018 trial (NCT03914612) of pembrolizumab (Keytruda) plus chemotherapy in patients with endometrial cancer.
The NRG GY018 trial investigated pembrolizumab (Keytruda) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin in patients with measurable stage III to IVA endometrial cancer, measurable or nonmeasurable stage IVB endometrial cancer, or recurrent endometrial cancer. Patients were stratified by mismatch repair–deficient (dMMR) or mismatch repair–proficient (pMMR) status based on immunohistochemistry findings. In the dMMR cohort, 112 patients were randomized to the pembrolizumab arm and 113 patients were randomized to the placebo arm. In the pMMR cohort, 295 and 296 patients were randomized to the pembrolizumab and placebo arms, respectively.
The prespecificed interim analysis of NRG GY018 was conducted when both the dMMR and pMMR cohorts had completed accrual and at least half of the information fraction had been collected, Eskander says. The interim analysis data cutoff date was December 16, 2022.
In the dMMR cohort, the median progression-free survival (PFS) was not reached in the patients who received pembrolizumab and 7.6 months in those who received placebo. The hazard ratio (HR) was 0.30, with a P value of less than .00001, translating to a 70% reduction in the risk of disease progression or death in these patients. Additionally, of the patients with dMMR disease, at 12 months, 74% of those who received pembrolizumab were alive with no evidence of disease progression compared with 38% of those who received placebo.
Patients in the pMMR cohort also consistently benefitted from the pembrolizumab combination, Eskander notes. In this cohort, the median PFS was 13.1 months in patients treated with pembrolizumab vs 8.7 months in those who received placebo. The HR was 0.54, with a P value of less than .00001, translating to a 46% reduction in the risk of disease progression or death in these patients, Eskander concludes.
Disclosures: Dr Eskander reports no disclosures.