![]() ![]() Seventy-nine percent of patients in the lenvatinib-pembrolizumab arm and 76% of patients in the TPC arm had 1 prior platinum-based therapy. Their proportions were relatively balanced between the 2 treatment arms. Serous histology was the most common nonendometrioid histology at just over 25%, followed by clear cell and mixed histologic subtypes. Endometrioid adenocarcinomas were the most common histology, as expected, and represented approximately 60% of cases in both the arms. Approximately 85% of patients in both arms were MMR-proficient. The arms were balanced with regard to patient age, prior radiation therapy, ECOG status, and race distribution. In this study, 827 patients were randomized between the 2 arms. The key exploratory end point on this study was duration of response. Secondary end points included objective response rate, quality of life analysis, as well as safety. The primary end points of the study were progression-free survival by blinded independent central review and overall survival. The maximum lifetime dose of doxorubicin allowed on this study was 500 mg/m2. Pembrolizumab in this study could be administered for up to a maximum of 35 doses, with lenvatinib continuing beyond that point as long as the patient was clinically benefiting. The MMR-proficient cohort were further stratified by region, ECOG status, and prior history of pelvic radiation.Įligible patients were randomized 1:1 to lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously every 3 weeks vs treatment of physician’s choice, where the options were doxorubicin 60 mg/m2IV every 3 weeks or paclitaxel 80 mg/m2, 3 weeks on, 1 week off. Patients were stratified by their MMR status. ![]() ![]() There was no restriction on prior hormonal therapy in this study. Patients in this study had to have 1, but were allowed 2, prior platinum-based lines of therapy, as long as 1 was administered in the adjuvant or neoadjuvant setting. The key eligibility criteria for this study included advanced metastatic or recurrent endometrial cancers with measurable disease by RECIST 1.1 guidelines per blinded independent central review. This is an open-label, randomized, phase 3 confirmatory trial of oral tyrosine kinase inhibitor lenvatinib and anti–PD-1 monoclonal antibody pembrolizumab vs treatment of physician’s choice in advanced endometrial cancers following at least 1 prior platinum-based regimen. Vicky Makker, MD: I’m going to discuss the efficacy data and review the primary and secondary end points from Study 309, or KEYNOTE-775. ![]()
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