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

  Ref: Businesswire | Image: Merck