FDA OKs Pembrolizumab/Lenvatinib Combo for Advanced Endometrial Carcinoma


The FDA approval of pembrolizumab plus lenvatinib for this new indication is the first under a new international collaboration with Australia and Canada.

Officials with FDA have granted accelerated approval to pembrolizumab (Keytruda, Merck) plus lenvatinib (Lenvima, Eisai) for the treatment of certain patients with advanced endometrial carcinoma, according to a press release.

The US approval was granted under a new international collaboration with Australia and Canada, an initiative called Project Orbis, allowing for simultaneous decisions in all 3 countries. Project Orbis, conducted under the FDA Oncology Center of Excellence, provides a framework for concurrent submission and review of oncology drugs among international partners.

With this approval, the combination treatment is indicated for use in patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy.

Endometrial cancer, the most common cancer of the female genital tract, occurs when cancer cells form in the tissues of the inner lining of the uterus. Factors such as obesity, metabolic syndrome, and certain estrogen promoting medications can increase the risk of this type of cancer.

Pembrolizumab plus lenvatinib demonstrated efficacy in the KEYNOTE-146 study, which included 108 patients with metastatic endometrial carcinoma that had progressed following at least 1 prior systemic therapy in any setting. For the study, patients were treated with lenvatinib 20 mg orally once daily in combination with pembrolizumab 200 mg administrated intravenously every 3 weeks until unacceptable toxicity or disease progression. Of the 108 patients in the study, 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.

According to the results, the overall response rate (ORR) in the 94 patients whose tumors were not MSI-H or dMMr was 38.3% (95% CI: 29%, 49%) with 10 complete responses (10.6%) and 26 partial responses (27.7%). Of these patients, 69% of responders have a DOR greater than 5 months.

Common adverse reactions observed in the study included fatigue, high blood pressure, musculoskeletal pain, diarrhea, decrease appetite, hypothyroidism, nausea, and stomatitis.

“We are pleased to be working alongside our Australian and Canadian colleagues to help make potentially life-changing treatments available to patients as quickly as possible while still ensuring the FDA’s high standards of safety and effectiveness,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement. “As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative as we work to help further serve the global patient community.”

For endometrial carcinoma, the recommended dose is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.


FDA takes first action under new international collaboration with Australia and Canada designed to provide new framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma [news release]. FDA. https://www.fda.gov/news-events/press-announcements/fda-takes-first-action-under-new-international-collaboration-australia-and-canada-designed-provide. Accessed September 17, 2019.

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