Regular FDA approval for Keytruda plus Lenvima in endometrial cancer

The US Food and Drug Administration approved Keytruda (pembrolizumab) from Merck & Co (NYSE: MRK) in combination with Japanese drugmaker Eisai’s (TYO: 4523) Lenvima (lenvatinib) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

The FDA granted accelerated approval on September 17, 2019 to pembrolizumab with lenvatinib for advanced endometrial carcinoma.

The approval for this population is based on results from the pivotal Phase III KEYNOTE-775/Study 309 trial, in which Keytruda plus Lenvima demonstrated statistically-significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; p=0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.50-0.72]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel).