Europe Approves Merck-Eisai's Keytruda/Lenvima Combo Therapy For Endometrial Carcinoma

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  • The European Commission has approved a combination of Merck & Co Inc's MRK Keytruda plus Eisai Co Ltd's ESALY Lenvima for advanced or recurrent endometrial carcinoma.
  • The approval covers adult patients who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and are not candidates for curative surgery or radiation. 
  • The approval is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which Keytruda plus Lenvima demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38%, and progression-free survival (PFS), reducing the risk of disease progression or death by 44%. 
  • The median OS was 18.3 months for Keytruda plus Lenvima versus 11.4 months for chemotherapy. The median PFS was 7.2 months for Keytruda plus Lenvima versus 3.8 months for chemotherapy. 
  • The objective response rate was 32% in Keytruda plus Lenvima arm versus 15% in chemotherapy patients.
  • Price Action: MRK shares are down 3.37% at $76.49 during the market session on the last check Monday.
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