European patients with recurrent or advanced endometrial carcinoma have a new treatment option, as the European Commission (EC) has approved KEYTRUDA plus LENVIMA. Approval is specifically for adult patients whose disease has progressed despite treatment with a platinum‑containing therapy and who are not candidates for radiation or curative surgery.
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.
Approval for KEYTRUDA and LENVIMA
KEYTRUDA, also referred to as pembrolizuab, was developed by Merck, while LENVIMA (lenvatinib) is an Eisai product. The approval of this combination marks the availability of the first treatment regimen that combines a tyrosine kinase inhibitor (LENVIMA) with immunotherapy (KEYTRUDA).
This approval was based on the Phase 3 KEYNOTE-775/Study 309 trial, which included 827 endometrial carcinoma patients. This trial was randomized, multi-center, active-controlled, and open-label in an effort to measure overall survival (OS) and progression-free survival (PFS), with a secondary endpoint of objective response rate (ORR). The results of this trial include:
- Risk of death was reduced by 38%
- Risk of disease progression was reduced by 44%
- Median OS was 18.3 months
- This is comparable to 11.4 months for patients being treated with chemotherapy
- Median PFS was 7.2 months
- This is comparable to 3.8 months for chemotherapy patients
- The ORR was was 32%
- This is comparable to 15% for chemotherapy patients
- A complete response (CR) rate of 7%
- This can be compared to 3% of the chemotherapy group
- A partial response (PR) rate of 25%
- This can be compared to 12% of the chemotherapy group
In terms of safety, 530 patients were included in the safety analysis. Common adverse events (AEs) include hypothyroidism, loss of appetite, nausea, diarrhea, hypertension, proteinuria, weight loss, fatigue, vomiting, headache, urinary tract infection, dysphonia, anemia, abdominal pain, arthralgia, constipation, hypomagnesemia, and palmar-plantar erythrodysesthesia syndrome and stomatitis.
With this data, the EC approved KEYTRUA plus LENVIMA for all members of the European Union. Now, endometrial cancer patients can join advanced renal cell carcinoma (RCC) patients in being treated with this combination.
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