Benzinga | Nov 30, 2021 04:02PM EST

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

* The European Commission has approved a combination of Merck & Co Inc's (NYSE:MRK) Keytruda plus Eisai Co Ltd's (OTC:ESALY) Lenvima for advanced or recurrent endometrial carcinoma.

* The approval covers adult patients who have disease progression on or following prior treatment with a platinumcontaining 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.