FDA Approves Merck's Keytruda for Endometrial Cancer

Merck & Co, known as MSD outside of the US and Canada, has received expanded approval from the US Food and Drug Administration (FDA) for the use of Keytruda in treating endometrial cancer. This anti-PD-1 therapy is now authorized to be used in combination with carboplatin and paclitaxel, followed by Keytruda alone, for adults suffering from primary advanced or recurrent endometrial carcinoma.

In the United States, approximately 67,880 new cases of uterine cancer are expected to be diagnosed this year, and endometrial carcinoma is the most prevalent type. Keytruda is administered intravenously and functions by enhancing the immune system's ability to recognize and combat tumor cells. This therapy already has a variety of approvals in the US, including for two other indications in endometrial carcinoma, both as a standalone treatment and in combination with Eisai’s Lenvima (lenvatinib).

The FDA's recent decision was based on encouraging outcomes from the late-stage KEYNOTE-868 trial. In this trial, the Keytruda regimen lowered the risk of disease progression or death by 40% in patients with mismatch repair proficient (pMMR) cancer and by 70% in those with mismatch repair deficient (dMMR) disease, in comparison to a placebo combined with carboplatin and paclitaxel followed by a placebo alone.

For patients with pMMR cancer, the median progression-free survival (PFS) in the Keytruda regimen group was 11.1 months, compared to 8.5 months in the placebo group. For those with dMMR disease, the median PFS was not reached in the Keytruda group, while it was 6.5 months in the placebo group.

Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, stated, “This approval represents the first and only anti-PD-1-based option for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. It builds on the established role of Keytruda in certain types of advanced endometrial carcinoma as a monotherapy and in combination with Lenvima.”

In addition to endometrial carcinoma, Keytruda has approvals for treating various other cancers, such as specific cases of cervical cancer, bladder cancer, biliary tract cancer, non-small cell lung cancer, and renal cell carcinoma. There are also over 1,600 ongoing trials examining the therapy, including one that is evaluating its use in combination with an investigational skin cancer vaccine developed by Merck and Moderna.

This expanded FDA approval marks a significant development in the treatment options available for endometrial carcinoma, providing new hope for patients diagnosed with this type of cancer. The ability of Keytruda to work in combination with traditional chemotherapy agents like carboplatin and paclitaxel, and subsequently as a monotherapy, presents a comprehensive approach to tackling the disease. This combination aims to harness the power of the immune system to improve patient outcomes significantly, highlighting the ongoing advancements in cancer immunotherapy.