26 July 2021 - - The US Food and Drug Administration has approved the combination of Keytruda, US-based biopharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Japanese pharmaceutical company Eisai (OTC: ESALY), for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, the company said.

The approval for this population 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, reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; p=0.0001), and progression-free survival, reducing the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.50-0.72]; p