부산대학교 도서관

Objective: In the global phase 3 Study 309/KEYNOTE-775 (NCT03517449) at the first interimanalysis, lenvatinib+pembrolizumab significantly improved progression-free sur vival (PFS),overall sur vival (OS), and objective response rate (ORR) versus treatment of physician’schoice chemotherapy (TPC) in patients with previously treated advanced/recurrentendometrial cancer (EC). This explorator y analysis evaluated outcomes in patients enrolledin East Asia at the time of prespecified final analysis. Methods: Women ≥18 years with histologically confirmed advanced, recurrent, or metastaticEC 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 orallyonce daily plus pembrolizumab 200 mg intravenously ever y 3 weeks (≤35 cycles) or TPC(doxorubicin or paclitaxel). Primar y endpoints were PFS per RECIST v1.1 by blindedindependent 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 inter vals (CIs) for PFS (lenvatinib+pembrolizumabvs. 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 adverseevents occurred in 97% and 96% (grade 3–5, 74% and 72%), respectively. Conclusion: Lenvatinib+pembrolizumab provided clinically meaningful benefit withmanageable safety compared with TPC, supporting its use in East Asian patients withpreviously treated advanced/recurrent EC. Trial Registration: ClinicalTrials.gov Identifier: NCT03517449
Objective: In the global phase 3 Study 309/KEYNOTE-775 (NCT03517449) at the first interimanalysis, lenvatinib+pembrolizumab significantly improved progression-free sur vival (PFS),overall sur vival (OS), and objective response rate (ORR) versus treatment of physician’schoice chemotherapy (TPC) in patients with previously treated advanced/recurrentendometrial cancer (EC). This explorator y analysis evaluated outcomes in patients enrolledin East Asia at the time of prespecified final analysis. Methods: Women ≥18 years with histologically confirmed advanced, recurrent, or metastaticEC 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 orallyonce daily plus pembrolizumab 200 mg intravenously ever y 3 weeks (≤35 cycles) or TPC(doxorubicin or paclitaxel). Primar y endpoints were PFS per RECIST v1.1 by blindedindependent 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 inter vals (CIs) for PFS (lenvatinib+pembrolizumabvs. 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 adverseevents occurred in 97% and 96% (grade 3–5, 74% and 72%), respectively. Conclusion: Lenvatinib+pembrolizumab provided clinically meaningful benefit withmanageable safety compared with TPC, supporting its use in East Asian patients withpreviously treated advanced/recurrent EC. Trial Registration: ClinicalTrials.gov Identifier: NCT03517449