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- Title
Analysis of East Asia subgroup in Study 309/KEYNOTE-775: lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer.
- Authors
Kan Yonemori; Keiichi Fujiwara; Kosei Hasegawa; Mayu Yunokawa; Kimio Ushijima; Shiro Suzuki; Ayumi Shikama; Shinichiro Minobe; Tomoka Usami; Jae-Weon Kim; Byoung-Gie Kim; Peng-Hui Wang; Ting-Chang Chang; Keiko Yamamoto; Shirong Han; McKenzie, Jodi; Orlowski, Robert J.; Takuma Miura; Makker, Vicky; Yong Man Kim
- Abstract
Objective: In the global phase 3 Study 309/KEYNOTE-775 (NCT03517449) at the first interim analysis, lenvatinib+pembrolizumab significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) versus treatment of physician's choice chemotherapy (TPC) in patients with previously treated advanced/recurrent endometrial cancer (EC). This exploratory analysis evaluated outcomes in patients enrolled in East Asia at the time of prespecified final analysis. Methods: Women =18 years with histologically confirmed advanced, recurrent, or metastatic EC with progressive disease after 1 platinum-based chemotherapy (2 if 1 given in neoadjuvant/adjuvant setting) were enrolled. Patients were randomized 1:1 to lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously every 3 weeks (=35 cycles) or TPC (doxorubicin or paclitaxel). Primary endpoints were PFS per RECIST v1.1 by blinded independent central review and OS. No alpha was assigned for this subgroup analysis. Results: Among 155 East Asian patients (lenvatinib+pembrolizumab, n=77; TPC, n=78), median follow-up time (data cutoff: March 1, 2022) was 34.3 (range, 25.1-43.0) months. Hazard ratios (HRs) with 95% confidence intervals (CIs) for PFS (lenvatinib+pembrolizumab vs. TPC) were 0.74 (0.49-1.10) and 0.64 (0.44-0.94) in the mismatch repair proficient (pMMR) and all-comer populations, respectively. HRs (95% CI) for OS were 0.68 (0.45-1.02) and 0.61 (0.41-0.90), respectively. ORRs were 36% with lenvatinib+pembrolizumab and 22% with TPC (pMMR) and 39% and 21%, respectively (all-comers). Treatment-related adverse events occurred in 97% and 96% (grade 3-5, 74% and 72%), respectively. Conclusion: Lenvatinib+pembrolizumab provided clinically meaningful benefit with manageable safety compared with TPC, supporting its use in East Asian patients with previously treated advanced/recurrent EC.
- Subjects
EAST Asia; ENDOMETRIAL cancer; EAST Asians; PHYSICIANS; CANCER chemotherapy; ADVERSE health care events; HEREDITARY nonpolyposis colorectal cancer
- Publication
Journal of Gynecologic Oncology, 2024, Vol 35, Issue 2, p1
- ISSN
2005-0380
- Publication type
Article
- DOI
10.3802/jgo.2024.35.e40