USA – According to a news release from, Merck, the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient.

Anti-PD-1 therapy was also approved for patients who had disease progression after previous systemic therapy but were not candidates for radiation or curative surgery.

Keytruda A is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.

Notably, this is Keytruda’s second indication for endometrial cancer patients, with the first being in combination with Lenvima (lenvatinib) for the treatment of patients with advanced endometrial cancer who are not microsatellite instability-high or mismatch repair deficient, have disease progression after systemic therapy, and are not candidates for radiation or curative surgery.

“This FDA approval is great news for women facing advanced endometrial cancer,” said Dr. Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories, in the release.

“We have seen substantial progress in delivering treatment options for patients with advanced endometrial cancer with Keytruda, as monotherapy and in combination, with two approved indications in this area.”

The FDA granted approval based on new data from two different patient groups in the KEYNOTE-158 trial.

During a median follow-up of 16 months, patients treated with Keytruda had an objective response rate (a measure of response to treatment) of 46 percent, with a complete response rate (the disappearance of all cancer from treatment, but this does not mean it has been cured) of 12 percent.

A partial response rate (a decrease in tumor size or extent of cancer in the body from treatment) of 33 percent was also recorded in the study.

In the trial, 68 percent of the 41 patients who responded to Keytruda maintained their response for at least 12 months, and 44 percent maintained their response for at least 24 months.

In this trial, the median duration of response (the time a tumor continues to respond to treatment without growing or spreading) was not reached, indicating that patients continued to respond to treatment when the duration of response was assessed.

Keytruda’s safety information

Some side effects with Keytruda may be serious or fatal and include high blood pressure, heart dysfunction, liver injury or impairment, clogged arteries, proteinuria (increased levels of protein in urine).

Other adverse effects include kidney failure or impairment, fistula formation (a hole between two organs) and gastrointestinal perforation (the development of a hole through the gastrointestinal tract), diarrhea, low calcium levels in the blood, heart rhythm disorders, bleeding, reversible post-eclampsia, and reversible post-eclampsia.

Furthermore, because Lenvima can cause fetal harm when administered to pregnant women, women with reproductive potential should be advised to use contraception.

According to the release, immune-mediated side effects may occur at any time during or after Keytruda treatment and include colitis, inflamed lung tissue, endocrine gland disease, hepatitis, skin reactions, nephritis, complications of allogenic hematopoietic stem cell transplantation, and solid organ transplant rejection.

Early detection and management of side effects is critical for the safe use of Keytruda. According to the release, treatment should be withheld based on the severity of the side effect.

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