Keytruda plus Lenvima Approved for Certain Patients with Uterine Cancer

The United States Food and Drug Administration (FDA) granted accelerated approval to the combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and are not candidates for curative surgery or radiation.

The 111/KEYNOTE-146 single-arm clinical trial was the basis for the FDA approval. The study evaluated 108 women with metastatic endometrial carcinoma that had progressed following at least one prior systemic therapy. All patients were treated with the Keytruda + Lenvima combination every 3 weeks until they experienced disease progression or unacceptable side effects. 

Among the 108 patients, 94 had tumors that were not MSI-H or dMMR, 11 had tumors that were MSI-H or dMMR, and in 3 patients the tumor MSI-H or dMMR status was not known. Tumor MSI status was determined using a polymerase chain reaction test and MMR status was determined using an immunohistochemistry test.

The overall response rate in patients whose tumors were not MSI-H or dMMR was 38.3% with 10 complete responses (10.6%) and 26 partial responses (27.7%). The average duration of response in these advanced patients has not been reached at the time of analyses 69% of those responding to treatment have response durations greater than 6 months.

The combination of Keytruda and Lenvima appears to provide benefit to women with advanced uterine cancer that are not MSI-H or dMMR. Patients with uterine cancer should discuss the role of genomic testing and tumor profiling with their doctors as these tests can help determine whether newer precision cancer medicines like Keytruda and Lenvima will play a role in the management of their cancer.


  1. FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma. FDA website. Posted September 17, 2019. Accessed September 17, 2019. 
  2. Makker V, Rasco D, Vogelzang NJ, et al. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019;20(5):711-718. doi: 10.1016/S1470-2045(19)30020-8

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