In the analysis of OS among the all-comer population, pembrolizumab plus lenvatinib was found to reduce the risk of death by 38% (HR=0.62 p<0.0001), with a median OS of 18.3 months (95% CI: 15.2-20.5 number of events=188) versus 11.4 months for TPC (95% CI: 10.5-12.9 number of events=245). The PFS demonstrated pembrolizumab plus lenvatinib (n=411) reduced the risk of disease progression or death by 44% in the all-comer population (HR=0.56 p<0.0001).Īmong this population, the investigators observed a median PFS of 7.2 months (95% CI: 5.7-7.6 number of events=281) versus 3.8 months for chemotherapy (n=416 95% CI: 3.6-4.2 number of events=286), which was the given as the treatment of the physician’s choice (TPC) of either doxorubicin or paclitaxel. Additionally, the trial’s secondary efficacy endpoint was objective response rate (ORR), which was also assessed by BICR per RECIST v1.1, in the all-comer population, which included mismatch repair proficient (pMMR) and mismatch repair deficient (dMMR]) subgroups.įor both the all-comer population and the pMMR subgroup, the investigators conducted a median follow-up over a period of 11.4 months. PFS and OS were assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The dual primary endpoints were progression-free survival (PFS) and OS, which the study was able to meet. The trial assessed the combination treatment of the anti-PD-1 therapy pembrolizumab with the orally available multiple receptor tyrosine kinase inhibitor lenvatinib for the treatment of advanced, metastatic, or recurrent endometrial cancer following 1 prior platinum-based regimen in any setting. The trial results were presented during an oral plenary session at the Society of Gynecologic Oncology 2021 Virtual Annual Meeting on Women’s Cancer. Results from the phase 3 KEYNOTE-775/study 309 trial (NCT03517449) found that pembrolizumab (Keytruda Merck) plus lenvatinib (Lenvima Eisai) reduced risk of death by 38%, with a median overall survival (OS) of 18.3 months versus 11.4 months for treatment with chemotherapy, regardless of mismatch repair status.
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