Lenvatinib plus pembrolizumab versus sunitinib for advanced renal cell carcinoma: Japanese patients from the CLEAR study

被引：7

作者：

Eto, Masatoshi ^{[1
]}

Takagi, Toshio ^{[2
]}

Kimura, Go ^{[3
]}

Fukasawa, Satoshi ^{[4
,5
]}

Tamada, Satoshi ^{[6
]}

Miura, Yuji ^{[7
]}

Oya, Mototsugu ^{[8
]}

Sassa, Naoto ^{[9
]}

Anai, Satoshi ^{[10
]}

Nozawa, Masahiro ^{[11
]}

Sakai, Hideki ^{[12
]}

Perini, Rodolfo ^{[13
]}

Yusa, Wataru ^{[14
]}

Ikezawa, Hiroki ^{[15
]}

Narita, Tomoyuki ^{[16
]}

Tomita, Yoshihiko

机构：

[1] Kyushu Univ Hosp, Dept Urol, Fukuoka, Japan

[2] Tokyo Womens Med Univ Hosp, Dept Urol, Tokyo, Japan

[3] Nippon Med Coll Hosp, Dept Urol, Tokyo, Japan

[4] Chiba Canc Ctr, Prostate Ctr, Chiba, Japan

[5] Chiba Canc Ctr, Div Urol, Chiba, Japan

[6] Bell Land Gen Hosp, Dept Urol, Osaka, Japan

[7] Toranomon Gen Hosp, Dept Med Oncol, Tokyo, Japan

[8] Keio Univ Hosp, Dept Urol, Tokyo, Japan

[9] Aichi Med Univ, Dept Urol, Nagakute, Aichi, Japan

[10] Nara Med Univ, Dept Urol, Nara, Japan

[11] Kindai Univ Hosp, Dept Urol, Osaka, Japan

[12] Nagasaki Univ Hosp, Dept Urol, Nagasaki, Japan

[13] Merck & Co Inc, Rahway, NJ USA

[14] Eisai & Co Ltd, Japan & Asia Clin Dev Dept, Oncol Business Grp, Tokyo, Japan

[15] Eisai & Co Ltd, Med Dev Ctr, Clin Data Sci Dept, Tokyo, Japan

[16] Eisai & Co Ltd, Lenvima Alliance Management, Tokyo, Japan

来源：

CANCER MEDICINE | 2023年 / 12卷 / 06期

关键词：

CLEAR study; Japanese patients; lenvatinib; pembrolizumab; renal cell carcinoma; TRIAL;

D O I：

10.1002/cam4.5483

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BackgroundThe phase 3 CLEAR study demonstrated statistically significantly improved efficacy with lenvatinib plus pembrolizumab versus sunitinib, including progression-free survival and overall survival, in patients with previously untreated advanced renal cell carcinoma. This subset analysis investigated efficacy and safety in Japanese patients randomized to lenvatinib plus pembrolizumab or sunitinib in the CLEAR study. MethodsProgression-free survival, overall survival, tumor response, and safety were assessed in Japanese patients with previously untreated advanced renal cell carcinoma randomized to receive lenvatinib plus pembrolizumab (n = 42) or sunitinib (n = 31). Efficacy outcomes were analyzed by independent imaging review per Response Evaluation Criteria in Solid Tumors, version 1.1. ResultsProgression-free survival was longer with lenvatinib plus pembrolizumab than with sunitinib (median, 22.1 vs. 10.9 months; hazard ratio, 0.39; 95% CI, 0.20-0.74). Median overall survival was not estimable in the lenvatinib plus pembrolizumab arm and 30.6 months in the sunitinib arm (HR, 1.20; 95% CI, 0.39-3.66). Overall survival adjusted for the imbalance of Memorial Sloan-Kettering Cancer Center prognostic risk group favored lenvatinib plus pembrolizumab (hazard ratio, 0.67; 95% CI, 0.18-2.39). Objective response rate (69.0% vs. 45.2%; odds ratio, 2.71; 95% CI, 1.03-7.10) was higher and median duration of response (20.3 vs. 9.1 months) was longer with lenvatinib plus pembrolizumab versus sunitinib. Grade >= 3 treatment-emergent adverse events occurred in 95.2% versus 87.1% of patients in the lenvatinib plus pembrolizumab versus sunitinib arms. ConclusionsThese findings support lenvatinib plus pembrolizumab as a potential first-line treatment for Japanese patients with advanced renal cell carcinoma.

引用

页码：6902 / 6912

页数：11

共 50 条

[41] Lenvatinib plus pembrolizumab in Japanese patients with endometrial cancer: Results from Study 309/KEYNOTE-775 [J].

Yonemori, Kan ;

Yunokawa, Mayu ;

Ushijima, Kimio ;

Sakata, Jun ;

Shikama, Ayumi ;

Minobe, Shinichiro ;

Usami, Tomoka ;

Enomoto, Takayuki ;

Takehara, Kazuhiro ;

Hasegawa, Kosei ;

Yamagami, Wataru ;

Yamamoto, Keiko ;

Han, Shirong ;

Dutta, Lea ;

Orlowski, Robert ;

Miura, Takuma ;

Makker, Vicky ;

Fujiwara, Keiichi .

CANCER SCIENCE, 2022, 113 (10) :3489-3497

[42] Efficacy of pembrolizumab plus lenvatinib as first-line treatment for metastatic renal cell carcinoma with multiple brain metastases [J].

Matsumoto, Daisuke ;

Naiki, Taku ;

Naiki-Ito, Aya ;

Aoki, Maria ;

Kato, Shinji ;

Morikawa, Toshiharu ;

Shimizu, Nobuhiko ;

Gonda, Masakazu ;

Umemoto, Yukihiro ;

Yasui, Takahiro .

IJU CASE REPORTS, 2025, 8 (01) :5-9

[43] Pembrolizumab plus axitinib for the treatment of advanced renal cell carcinoma [J].

Spisarova, Martina ;

Melichar, Bohuslav ;

Vitaskova, Denisa ;

Studentova, Hana .

EXPERT REVIEW OF ANTICANCER THERAPY, 2021, 21 (07) :693-703

[44] Pembrolizumab plus axitinib versus sunitinib in metastatic renal cell carcinoma: outcomes of Japanese patients enrolled in the randomized, phase III, open-label KEYNOTE-426 study [J].

Tamada, Satoshi ;

Kondoh, Chihiro ;

Matsubara, Nobuaki ;

Mizuno, Ryuichi ;

Kimura, Go ;

Anai, Satoshi ;

Tomita, Yoshihiko ;

Oyama, Masafumi ;

Masumori, Naoya ;

Kojima, Takahiro ;

Matsumoto, Hiroaki ;

Chen, Mei ;

Li, Mengran ;

Matsuda, Kenji ;

Tanaka, Yoshinobu ;

Rini, Brian, I ;

Uemura, Hirotsugu .

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2022, 27 (01) :154-164

[45] Pembrolizumab plus axitinib versus sunitinib in metastatic renal cell carcinoma: outcomes of Japanese patients enrolled in the randomized, phase III, open-label KEYNOTE-426 study [J].

Satoshi Tamada ;

Chihiro Kondoh ;

Nobuaki Matsubara ;

Ryuichi Mizuno ;

Go Kimura ;

Satoshi Anai ;

Yoshihiko Tomita ;

Masafumi Oyama ;

Naoya Masumori ;

Takahiro Kojima ;

Hiroaki Matsumoto ;

Mei Chen ;

Mengran Li ;

Kenji Matsuda ;

Yoshinobu Tanaka ;

Brian I. Rini ;

Hirotsugu Uemura .

International Journal of Clinical Oncology, 2022, 27 :154-164

[46] Myocarditis Following Pembrolizumab Plus Axitinib, and Belzutifan Plus Lenvatinib for Renal Cell Carcinoma: A Case Report [J].

Villatore, Andrea ;

Bosi, Carlo ;

Pomaranzi, Chiara ;

Cigliola, Antonio ;

Tateo, Valentina ;

Mercinelli, Chiara ;

Vignale, Davide ;

Rizzo, Stefania ;

Necchi, Andrea ;

Peretto, Giovanni .

CARDIOVASCULAR TOXICOLOGY, 2024, 24 (11) :1168-1173

[47] Dose Escalation and Pharmacokinetics Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma [J].

Schmidinger, Manuela ;

Szczylik, Cezary ;

Sternberg, Cora N. ;

Kania, Marek ;

Kelly, Claudia Sue ;

Decker, Rodney ;

Hamid, Oday ;

Faelker, Taron ;

Escudier, Bernard .

AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS, 2012, 35 (05) :493-497

[48] A Matching-adjusted Indirect Comparison of Nivolumab Plus Cabozantinib Versus Pembrolizumab Plus Axitinib in Patients with Advanced Renal Cell Carcinoma [J].

McGregor, Bradley ;

Geynisman, Daniel M. ;

Burotto, Mauricio ;

Suarez, Cristina ;

Bourlon, Maria T. ;

Barata, Pedro C. ;

Gulati, Shuchi ;

Huo, Stephen ;

Ejzykowicz, Flavia ;

Blum, Steven I. ;

Del Tejo, Viviana ;

Hamilton, Melissa ;

May, Jessica R. ;

Du, Ella X. ;

Wu, Aozhou ;

Kral, Pavol ;

Ivanescu, Cristina ;

Chin, Andi ;

Betts, Keith A. ;

Lee, Chung-Han ;

Choueiri, Toni K. ;

Cella, David ;

Porta, Camillo .

EUROPEAN UROLOGY ONCOLOGY, 2023, 6 (03) :339-348

[49] Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) for Lenvatinib plus Everolimus Versus Everolimus Monotherapy in Patients with Advanced Renal Cell Carcinoma [J].

Lee, Chung-Han ;

Wan, Yin ;

Smith, Alan ;

Xie, Ran ;

Motzer, Robert J. .

EUROPEAN UROLOGY OPEN SCIENCE, 2021, 31 :1-9

[50] Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma [J].

Lorusso, Domenica ;

Danesi, Romano ;

Locati, Laura Deborah ;

Masi, Gianluca ;

De Giorgi, Ugo ;

Gadducci, Angiolo ;

Pignata, Sandro ;

Roberto, Sabbatini ;

Savarese, Antonella ;

Valabrega, Giorgio ;

Zamagni, Claudio ;

Colombo, Nicoletta .

FRONTIERS IN ONCOLOGY, 2022, 12

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