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

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.
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