In April 2021, the FDA accelerated the approval of a new immunotherapy, Jemperli (dostarlimab-gxly; from GlaxoSmithKline), a PD-1/PD-L1 inhibitor, for the treatment of recurrent or advanced endometrial cancer that is linked to a biomarker called mismatch repair-deficient (dMMR), as determined by an FDA-approved test, in patients whose disease progressed during or after a platinum-containing chemotherapy. The dMMR biomarker affects the proper repair of DNA inside the cell. Jemperli is the first immunotherapy to be approved by the FDA for patients with endometrial cancer.
“Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”
Endometrial cancer is the most common gynecologic cancer in the United States and is on the rise. Although the majority (about 75%) of endometrial cancers are diagnosed at an early stage and can be often cured by surgery, about 25% of cases have advanced and recurrent disease, which has few treatment options after chemotherapy. Of the women with advanced endometrial cancer, about 25% to 30% have dMMR tumors.
Jemperli inhibits the PD-1/PD-L1 proteins found on immune cells and some cancer cells, thereby helping the body’s immune system to fight the cancer cells by blocking these proteins.
The safety and effectiveness of Jemperli were demonstrated in a study of patients with different types of endometrial cancer. Of the 71 patients with recurrent or advanced dMMR endometrial cancer who received Jemperli, almost half (42.3%) had a complete response (no sign of cancer) or a partial response (shrinking tumor) to treatment with Jemperli. Among patients whose tumor responded to treatment with Jemperli, the response to therapy lasted 6 months or more in 93% of them.
The common side effects reported with Jemperli include fatigue, nausea, diarrhea, anemia, and constipation. Like all immunotherapies, Jemperli can cause serious side effects related to inflammation of healthy organs, including the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies), and kidneys (nephritis). Patients who have these severe reactions should stop taking Jemperli.
