Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval for the Treatment of Advanced Endometrial Carcinoma

Shots:

• The approval is based on P-III KEYNOTE-775/Study 309 trial evaluating Merck’s Keytruda (200mg, IV, q3w) + Eisai’s Lenvima (20mg, PO, qd) vs CT (doxorubicin, 60 mg/m2, IV, q3wks.) or paclitaxel (80 mg/m2, IV, 28-day cycle) in 827 patients with advanced EC that were not MSI-H or dMMR, prior treated with Pt-based regimen in any setting
• Results: improvements in OS (32% reduction in risk of death), 40% reduction in risk of disease progression or death, ORR (30% vs 15%) , CR rate (5% vs 3%) , PR rate (25% vs 13%), mDoR (6.8 vs 6.7mos.)
• Keytruda + Lenvima was previously approved under the FDA’s accelerated approval process as well as RTOR program & Project Orbis for EC

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