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
© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology..
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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03517449.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:35 |
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| Enthalten in: |
Journal of gynecologic oncology - 35(2024), 2 vom: 20. März, Seite e40 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Yonemori, Kan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 20.03.2024 Date Revised 21.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03517449 Citation Status MEDLINE |
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| doi: |
10.3802/jgo.2024.35.e40 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM367920891 |
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| 100 | 1 | |a Yonemori, Kan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Analysis of East Asia subgroup in Study 309/KEYNOTE-775 |b lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer |
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| 500 | |a Date Completed 20.03.2024 | ||
| 500 | |a Date Revised 21.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03517449 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03517449 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 650 | 4 | |a Endometrial Cancer | |
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| 700 | 1 | |a Fujiwara, Keiichi |e verfasserin |4 aut | |
| 700 | 1 | |a Hasegawa, Kosei |e verfasserin |4 aut | |
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| 700 | 1 | |a Ushijima, Kimio |e verfasserin |4 aut | |
| 700 | 1 | |a Suzuki, Shiro |e verfasserin |4 aut | |
| 700 | 1 | |a Shikama, Ayumi |e verfasserin |4 aut | |
| 700 | 1 | |a Minobe, Shinichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Usami, Tomoka |e verfasserin |4 aut | |
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| 700 | 1 | |a Kim, Byoung-Gie |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Peng-Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Chang, Ting-Chang |e verfasserin |4 aut | |
| 700 | 1 | |a Yamamoto, Keiko |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Shirong |e verfasserin |4 aut | |
| 700 | 1 | |a McKenzie, Jodi |e verfasserin |4 aut | |
| 700 | 1 | |a Orlowski, Robert J |e verfasserin |4 aut | |
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| 700 | 1 | |a Makker, Vicky |e verfasserin |4 aut | |
| 700 | 1 | |a Man Kim, Yong |e verfasserin |4 aut | |
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