Merck announced that Health Canada approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. The approval is based on data from the Phase 3 KEYNOTE-868 trial, also known as NRG-GY018, which demonstrated statistically significant improvements in progression-free survival (PFS) for patients randomized to KEYTRUDA® in combination with chemotherapy compared to placebo in combination with chemotherapy in both the deficient mismatch repair (dMMR) and proficient mismatch repair (pMMR) populations.
"Today's approval represents an important step forward in the treatment landscape for advanced or recurrent endometrial cancer, a condition that affects many women across Canada," expressed Dr. Alon Altman, Gynecologic Oncologist and Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Manitoba. "The use of immunotherapies, such as KEYTRUDA® alongside chemotherapy offers a new approach that may help address the specific needs of patients facing this diagnosis."
"NRG-GY018 represents the largest first-line immunotherapy trial in advanced or recurrent endometrial cancer," says André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "This exciting news means an additional option is now available to patients in need. Merck remains focused on supporting research and development that aims to provide meaningful contributions to patient care."
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