O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician's choice in patients with advanced endometrial cancer: study 309/keynote-775. (4th December 2022)

• Record Type: Journal Article
• Authors: Makker, Vicky; Colombo, Nicoletta; Herráez, Antonio Casado; Monk, Bradley; Mackay, Helen; Santin, Alessandro; Miller, David; Moore, Richard; Ray-Coquard, Isabelle; Shapira-Frommer, Ronnie; Ushijima, Kimio; Yonemori, Kan; Kim, Yong Man; Alia, Eva Guerra; Sanli, Ulus; Xie, Ran; Zale, Melissa; Mckenzie, Jodi; Barresi, Gianmaria; Lorusso, Domenica
• Is Part Of: International journal of gynecological cancer. Volume 32(2022)Supplement 3
• Page Start: A11
• Page End: A11
• Publication Date: 2022-12-04
• Subjects: Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2022-igcs.20
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Objectives: 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. Methods: 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 2 IV Q3W or paclitaxel 80 mg/m 2 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. Results: 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. Conclusions: 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.