![]() ![]() The combination of pembrolizumab and lenvatinib received breakthrough therapy designation for this indication. ![]() This application was granted priority review. The FDA approved this application 6 weeks prior to the FDA goal date. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. View full prescribing information for Lenvima. View full prescribing information for Keytruda. The recommended pembrolizumab dose for endometrial carcinoma is 200 mg every 3 weeks or 400 mg every 6 weeks with lenvatinib 20 mg orally once daily. The most common adverse reactions reported in ≥ 20% of patients in trials of pembrolizumab in combination with lenvatinib 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, dysphonia and rash. Additional efficacy outcome measures included objective response rate (ORR) and duration of response (DOR), also BICR-assessed.įor patients with advanced endometrial cancer that is not MSI-H or dMMR, the median PFS was 6.6 months (95% CI: 5.6, 7.4) for patients in the pembrolizumab and lenvatinib group and 3.8 months (95% CI: 3.6, 5.0) for those receiving investigator’s choice chemotherapy (HR 0.60 95% CI: 0.50, 0.72 p<0.0001). The major efficacy outcome measures were progression-free survival (PFS), as assessed by blinded independent central review (BICR), and overall survival (OS). Patients were randomized (1:1) to either pembrolizumab 200 mg intravenously every 3 weeks with lenvatinib 20 mg orally once daily or investigator’s choice of doxorubicin or paclitaxel. Study 309/KEYNOTE-775 enrolled 827 patients with advanced endometrial carcinoma previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including neoadjuvant and adjuvant treatments. Study 309/KEYNOTE-775 (NCT03517449) was a multicenter, open-label, randomized, active-controlled trial required to confirm the clinical benefit of this accelerated approval. On July 21, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.įDA granted accelerated approval on Septemto pembrolizumab with lenvatinib for advanced endometrial carcinoma. ![]()
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