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- W4312139692 abstract "<h3>Objectives</h3> In patients with advanced endometrial cancer (aEC), lenvatinib + pembrolizumab (L+P) demonstrated statistically significant and clinically meaningful improvements in PFS, OS, and ORR versus treatment of physician’s choice (TPC) at first efficacy interim analysis. Efficacy was maintained with extended follow-up at the final prespecified data cutoff (1 March 2022). Here we report additional safety/tolerability analyses from the same final prespecified data cutoff. <h3>Methods</h3> Detailed methods have been published [Makker 2022]. Briefly, patients with aEC and 1 prior platinum-based chemotherapy regimen (up to 2 if 1 given in the neoadjuvant/adjuvant setting) were randomized (1:1) to receive lenvatinib 20 mg orally QD + pembrolizumab 200 mg IV Q3W or TPC (doxorubicin 60 mg/m<sup>2</sup> IV Q3W or paclitaxel 80 mg/m<sup>2</sup> IV QW [3-weeks-on/1-week-off]). We report safety data of patients who received treatment with 16 months of additional follow-up since the primary analysis. <h3>Results</h3> 794 Patients treated with L+P (n=406) or TPC (n=388) were included. Data for these patients regarding adverse events are shown in the table 1. Dose interruptions due to treatment-emergent adverse events were experienced by 71.9% of patients treated with L+P (lenvatinib: 61.6%; pembrolizumab: 52.5%; L+P: 32.5%) and by 28.4% of patients treated with TPC. Dose reductions were needed for 67.2% of patients who received lenvatinib and 12.6% of patients who received TPC. Treatment was discontinued by 39.2% of patients who received L+P (lenvatinib: 35.7%; pembrolizumab: 22.2%; L+P: 16.0%) and by 8.0% of patients who received TPC. <h3>Conclusions</h3> In patients with aEC, updated safety/tolerability results with L+P over extended time were generally consistent with the primary analysis from Study 309/KEYNOTE-775." @default.
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- W4312139692 date "2022-12-01" @default.
- W4312139692 modified "2023-09-29" @default.
- W4312139692 title "O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775" @default.
- W4312139692 doi "https://doi.org/10.1136/ijgc-2022-igcs.20" @default.
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