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
收藏
页码:6902 / 6912
页数:11
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