FDA Grants Regular Approval to Jemperli for Endometrial Cancer Subset


The FDA granted a regular approval to patients with recurrent or advanced dMMR endometrial cancer.

The Food and Drug Administration (FDA) granted regular approval to Jemperli (dostarlimab-gxly) for the treatment of patients with recurrent or advanced DNA mismatch repair (dMMR) endometrial cancer, which would be determined by an FDA-approved test.

To be eligible for treatment, patients must have experienced disease progression on a platinum-containing regimen and are not eligible for curative surgery or radiation, according to the agency. This full approval comes after the accelerated approval for Jemperli in this patient population in April 2021.

This approval is based on findings from the GARNET clinical trial of patients with advanced solid tumors. There was a group of 141 patients with dMMR recurrent or advanced endometrial cancer who progressed on prior therapy. Of note, patients who were previously treated with immunotherapy were excluded from this trial.

Study findings showed that 45.4% of patients responded to treatment, meaning that their tumors shrank from the drug. This includes 15.6% of patients who experienced a complete response (no detectable traces of cancer) and 29.8% of patients experiencing a partial response. The majority of patients (85.9%) had a response that lasted 12 months or longer, and 54.7% had a duration of response of 24 months or longer.

The most common side effects that occurred in 20% or more of patients were fatigue/weakness, anemia, rash, nausea, diarrhea, constipation and vomiting. Immune-related side could also occur including lung tissue inflammation, colitis, hepatitis, endocrinopathies (disease of an endocrine gland), nephritis (inflamed kidney tissue) with renal dysfunction and skin reactions.

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