Shots:

• The approval is based on the P-III (KEYNOTE-775/Study 309) trial to evaluate Keytruda (200mg, IV, q3w) + Lenvima (20mg, PO, qd) vs doxorubicin (60mg/m2, IV, q3w) or paclitaxel (80mg/m2, IV, 28-day cycle) in a ratio (1:1) in 827 patients with EC prior treated with 1 Pt-based CT regimen in any setting including neoadjuvant & adjuvant settings
• The results showed improvements in OS & PFS with a 38% reduction in risk of death & 44% in disease progression or death, m-OS (18.3mos. vs 11.4mos.), m-PFS (7.2mos. vs 3.8mos.)
• The combination marks 1st approval in Japan & has received ODD from the MHLW for EC. The companies continue to study the combination across multiple cancer

Ref: Merck | Image: Merck