In this article
FDA Approval and Regulatory Background
August 2021: Pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) has been approved by the Food and Drug Administration for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression after prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
On September 17, 2019, the FDA awarded pembrolizumab plus lenvatinib expedited approval for advanced endometrial cancer. The multicenter, open-label, randomised, active-controlled study 309/KEYNOTE-775 (NCT03517449) was necessary to confirm the clinical benefit of this accelerated authorisation.
Study 309/KEYNOTE-775 Design
827 patients with advanced endometrial cancer were enrolled in Study 309/KEYNOTE-775, who had previously had at least one platinum-based chemotherapy regimen in any setting, including neoadjuvant and adjuvant treatments. Patients were randomly assigned (1:1) to receive pembrolizumab 200 mg intravenously every 3 weeks with lenvatinib 20 mg orally once daily, or doxorubicin or paclitaxel, as determined by the investigator.
Efficacy Results: Survival and Response Rates
Progression-free survival (PFS), as determined by blinded independent central review (BICR), and overall survival (OS) were the primary efficacy outcome measures. The objective response rate (ORR) and duration of response (DOR), both assessed by the BICR, were additional efficacy outcome measures.
The median PFS for patients with advanced endometrial cancer that was not MSI-H or dMMR was 6.6 months (95 percent CI: 5.6, 7.4) for those receiving pembrolizumab and lenvatinib and 3.8 months (95 percent CI: 3.6, 5.0) for those receiving investigator’s choice chemotherapy (HR 0.60; 95 percent CI: 0.50, 0.72; p0.0001) for those receiving investigator’s choice chemotherapy. The median OS was 17.4 months (95 percent confidence interval: 14.2, 19.9) for men and 12.0 months (95 percent confidence interval: 10.8, 13.3) for women (HR 0.68; 95 percent confidence interval: 0.56, 0.84; p=0.0001). ORRs were 30% (95 percent confidence interval: 26, 36) and 15% (95 percent confidence interval: 12, 19), respectively (p0.0001). 9.2 months (1.6+, 23.7+) and 5.7 months (0.0+, 24.2+) were the median DORs.
Safety Profile and Recommended Dosage
Hypothyroidism, hypertension, fatigue, diarrhoea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysestrophy, palmar-plantar erythrodysestrophy, palmar-plantar erythrodysestrophy, palmar-plantar erythro
Pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks with lenvatinib 20 mg orally once daily is the recommended dose for endometrial cancer.
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About Alysha Mendossa
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