FDA Grants Priority Review to Merck’s Keytruda Combo for Endometrial Carcinoma

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The FDA has granted priority review to Merck’s new supplemental biologics license application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, with chemotherapy (carboplatin and paclitaxel) to treat primary advanced or recurrent endometrial carcinoma, alongside chemotherapy (carboplatin and paclitaxel). The Prescription Drug User Fee Act date for the FDA’s decision is scheduled for June 21, 2024.

This sBLA used results from a Phase III NRG-GY018 trial—sponsored by the US National Cancer Institute—indicating that Keytruda plus chemotherapy decreased the risk of disease progression or death by 46% (HR=0.54 [95% CI, 0.41-0.71]; p<0.00001) in patients where cancer was mismatch repair proficient (pMMR) by 70% (HR=0.30 [95% CI, 0.19-0.48]; p<0.00001) in patients whose cancer was mismatch repair deficient (dMMR), compared to only chemotherapy.

“If approved, Keytruda would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer regardless of mismatch repair status,” said Dr. Gursel Aktan, VP of global clinical development at Merck Research Laboratories. “We are committed to working closely with the FDA to bring Keytruda to these patients who are in need of additional treatment options, and we thank our collaborators for their partnership on this study.”

In the United States, the therapy currently has two approved indications in the area of endometrial cancer. One indication, which based on KEYNOTE-775/Study 309, is in conjunction with LENVIMA (lenvatinib), also with Eisai, for patients with advanced endometrial carcinoma that is pMMR (as noted by an FDA-approved test), or not microsatellite instability-high (MSI-H), who have disease progression following any previous systemic therapy in any setting and are not candidates for curative surgery or radiation. The second indication is based on KEYNOTE-158, as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR (as noted by an FDA-approved test) who have disease progression following prior systemic therapy in any setting and are not candidates for any type of curative surgery or radiation.

These approvals come out a time when endometrial cancer continues to increase in prevalence.

“Endometrial cancer is the most common type of gynecological cancer, and frontline treatment options are limited for patients with advanced stage or recurrent disease,” noted Dr. Ramez Eskander, principal investigator and gynecologic oncologist, University of California San Diego, Moores Cancer Center. “The use of Keytruda in this setting has the potential to address a significant unmet need for these patients.”

Reference

FDA Grants Priority Review to Merck’s Application for KEYTRUDA (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma. Merck. News release. February 20, 2024. Accessed February 21, 2024. https://www.merck.com/news/fda-grants-priority-review-to-mercks-application-for-keytruda-pembrolizumab-plus-chemotherapy-as-treatment-for-primary-advanced-or-recurrent-endometrial-carcinoma/