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Merck and Eisai's Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive MHLW's Approval for the Treatment of Endometrial Carcinoma

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Merck and Eisai's Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive MHLW's Approval for the Treatment of Endometrial Carcinoma

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  • 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

Click here to­ read the full press release 

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