The United States Food and Drug Administration (FDA) has granted priority review for a new supplemental Biologics License Application (sBLA) for a combination treatment with Merck & Co’s (MSD) Keytruda (pembrolizumab) and chemotherapy for advanced or recurrent endometrial carcinoma.
Keytruda is already approved in combination with Eisai’s Lenvima (lenvatinib) for the treatment of advanced endometrial carcinoma that is not microsatellite-high (MSI-H) or deficient mismatch repair (dMMR). With the latest priority review, it could be indicated as a combination treatment with chemotherapy that is followed by a single-agent Keytruda in this indication. As per the press release, the treatment has a Prescription Drug User Fee Act (PDUFA) of 21 June 2024.
The priority review was granted based on results from a National Cancer Institute (NCI)-sponsored Phase III (NCT03914612) study, dubbed NRG-GY018, a randomised, placebo-controlled clinical trial evaluating the efficacy of adding Keytruda to standard of care chemotherapy for stage III-IV or recurrent endometrial cancer.
Compared to standard of care chemotherapy alone, the study reported that the addition of Keytruda was demonstrated to decrease the risk of disease progression or death by 46% in patients with mismatch repair proficient (pMMR) cancer and 70% in patients with dMMR endometrial cancer, as shared at the 2023 Society of Gynecologic Oncology (SGO) on Women’s Cancer meeting.
The study used progression-free survival (PFS) as its primary outcome measure and employed various secondary outcome measures which included safety, overall survival, and health-related quality of life. As per the press release, the study showed “statistically significant and clinically meaningful improvement” in PFS.
“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, vice president, global clinical development at Merck Research Laboratories in the 20 February press release.
Merck & Co has started the year off strong following a 12 January label expansion for Keytruda to treat certain types of advanced cervical cancer in combination with chemoradiotherapy. The expansion marked the third FDA approval for Keytruda in cervical cancer.
The pharma giant’s Keytruda is also a key player in the global NSCLC market with the treatment gaining approval in combination with chemotherapy in a neoadjuvant setting in October 2023.
GlobalData estimates Keytruda to bring in over $33bn in 2028.
GlobalData is the parent company of Pharmaceutical Technology.
