FDA Approves Keytruda/Lenvima Combo for Advanced Endometrial Cancer


The Food and Drug Administration approved Keytruda plus Lenvima for patients with advanced endometrial carcinoma whose disease had progressed after previous systemic therapy and are not candidates for surgery or radiation.

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) plus Lenvima (Lenvatinib) for patients with advanced endometrial carcinoma that is not microsatellite instability-high or DNA mismatch repair deficient that has progressed after systemic therapy and is ineligible for curative surgery or radiation.

Today’s full approval comes after the September 2019 accelerated approval, which was based on findings from the Study 309/KEYNOTE-775 clinical trial. The trial included 827 patients with advanced endometrial carcinoma who were previously treated with one or more platinum-based chemotherapy in any setting. Half of the patients on the trial received 200 milligrams of intravenous Keytruda every three weeks with 20 milligrams of oral Lenvima daily, while the other half was given investigator’s choice of doxorubicin or paclitaxel chemotherapy.

Average progression-free survival, meaning the time survived without the disease getting worse, was 6.6 months in the Keytruda/Lenvima group compared to 3.8 months in the chemotherapy group. Average overall survival was 17.4 months with the two-drug treatment compared with 12 months with chemotherapy.

Overall, 30% of patients responded to Keytruda/Lenvima compared to half of that — 15% — with chemotherapy. On average, responses lasted 9.2 months and 5.7 months in the investigative and chemotherapy groups, respectively.

Common side effects that occurred at least 20% of patients receiving Keytruda/Lenvima were: hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysesthesia (hand-foot syndrome), dysphonia and rash.

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