US FDA approves pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial cancer
The combination has been approved for the treatment of advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, that has progressed following prior systemic therapy and is not amenable to curative surgery or radiation.
Source:
Biospace Inc.
SPS commentary:
The approval is based on results from the Phase III KEYNOTE-775/Study 309 trial, in which pembrolizumab plus lenvatinib was associated with improvements in overall survival (HR for risk of death = 0.68; 95% CI 0.56-0.84; p=0.0001) and progression-free survival (HR 0.60 [0.50-0.72]; p<0.0001), when compared to chemotherapy (investigator’s choice of doxorubicin or paclitaxel).