The FDA has recently approved KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) for the treatment of advanced endometrial carcinoma that is not mismatch repair deficiency or microsatellite instability-high. This approval came after positive results from the Phase 3 KEYNOTE-775/Study 309 trial.
Approval for KEYTRUDA Plus LENVIMA
A phase 3 trial produced the data that led the FDA to approve this drug combination. Titled KEYNOTE-775/Study 309 trial, it demonstrated statistically significant results in regard to progression-free survival (PFS) and overall survival (OS). In order to best evaluate the treatment, researchers compared the combination to chemotherapy (doxorubicin or paclitaxel). Results include:
- OS: The drug combination reduced the risk of death by 32%
- PFS: The drug combination reduced the risk of disease progression and death by 40%
- Objective response rate (ORR): 30% for KEYTRUDA plus LENVIMA vs. 15% for chemotherapy
- Complete response rate: 5% vs. 3%
- Partial response rate: 25% vs. 13%
Merck, which is responsible for KEYTRUDA, and Eisai, the maker of LENVIMA, are very excited by this recent approval. They are hopeful that this treatment combination will lead to improved outcomes for patients with advanced endometrial carcinoma.
About Endometrial Carcinoma
Endometrial carcinoma is the most common form of cancer that forms in the uterus. Specifically, it begins to develop in the uterine lining. Medical professionals are unsure as to why this happens, but they have identified a number of risk factors: never being pregnant, later menopause, earlier menstruation, older age, obesity, changes in female hormones, hormone therapy administered for breast cancer, and an inherited colon cancer syndrome.
Regardless of cause or risk factors, symptoms of this cancer include vaginal bleeding in between periods, pelvic pain, and vaginal bleeding that occurs after menopause. Treatment for this cancer typically means removing the Fallopian tubes, uterus, and ovaries. If this cannot occur, other treatment options include chemotherapy, targeted drug therapy, radiation, immunotherapy, hormone therapy, and supportive care.
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