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.
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.
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