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Transl Oncol. 2019 Apr 9;12(6):828-835. doi: 10.1016/j.tranon.2019.02.007. [Epub ahead of print]

A Phase Ib Study of Pembrolizumab as Second-Line Therapy for Chinese Patients With Advanced or Metastatic Melanoma (KEYNOTE-151).

Si L1, Zhang X2, Shu Y3, Pan H4, Wu D5, Liu J6, Lou F7, Mao L8, Wang X9, Wen X10, Gu Y11, Zhu L12, Lan S13, Cai X14, Diede SJ15, Zhou Y16, Ge J17, Li J18, Wu H19, Guo J20.

Author information

1
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Kidney Cancer and Melanoma, Peking University Cancer Hospital & Institute, 52# Fucheng Road, Haidian District, 100142, Beijing, China. Electronic address: silu15_silu@126.com.
2
Sun Yat-sen University Cancer Centre, 651 Dongfeng E Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, Guangzhou, China. Electronic address: zhangxsh@sysucc.org.cn.
3
Jiangsu Province Hospital, 300 Guangzhou Rd, Gulou Qu, Nanjing Shi, 210029, Jiangsu Sheng, China. Electronic address: shuyongqian@csco.org.cn.
4
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 Qingchun E Rd, XinCheng ShangQuan, Jianggan Qu, Hangzhou Shi, Zhejiang Sheng, 310016, Zhejiang, China. Electronic address: panhongming@zju.edu.cn.
5
The First Hospital of Jilin University, 3808 Jiefang Rd, HongQiJie, Chaoyang Qu, Changchun Shi, Jilin Sheng, 130021, Jilin, China. Electronic address: wudi888991@163.com.
6
The First Affiliated Hospital of Dalian Medical University, 222 Zhongshan Rd, Xigang Qu, Dalian Shi, 116011, Liaoning Sheng, China. Electronic address: Jiweiliudl@126.com.
7
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 Qingchun E Rd, XinCheng ShangQuan, Jianggan Qu, Hangzhou Shi, Zhejiang Sheng, 310016, Zhejiang, China. Electronic address: loufang101@126.com.
8
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Kidney Cancer and Melanoma, Peking University Cancer Hospital & Institute, 52# Fucheng Road, Haidian District, 100142, Beijing, China. Electronic address: yunzhongmanbu7848@163.com.
9
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Kidney Cancer and Melanoma, Peking University Cancer Hospital & Institute, 52# Fucheng Road, Haidian District, 100142, Beijing, China. Electronic address: w_xuan_md@126.com.
10
Sun Yat-sen University Cancer Centre, 651 Dongfeng E Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, Guangzhou, China. Electronic address: wenxzh@sysucc.org.cn.
11
Jiangsu Province Hospital, 300 Guangzhou Rd, Gulou Qu, Nanjing Shi, 210029, Jiangsu Sheng, China. Electronic address: guyanhong@njmu.edu.cn.
12
Jiangsu Province Hospital, 300 Guangzhou Rd, Gulou Qu, Nanjing Shi, 210029, Jiangsu Sheng, China. Electronic address: zhulingjun@njmu.edu.cn.
13
The First Hospital of Jilin University, 3808 Jiefang Rd, HongQiJie, Chaoyang Qu, Changchun Shi, Jilin Sheng, 130021, Jilin, China. Electronic address: lanjie3@sina.com.
14
The First Affiliated Hospital of Dalian Medical University, 222 Zhongshan Rd, Xigang Qu, Dalian Shi, 116011, Liaoning Sheng, China. Electronic address: Babydocone@126.com.
15
Merck & Co. Inc., 2000 Galloping Hill Rd, 07033, Kenilworth, NJ, USA. Electronic address: scott.diede@merck.com.
16
MSD, Building A, Headquarters Park Phase 2, 1582 Gumei Road, Xuhui District, 200233, Shanghai, China. Electronic address: yu.zhou1@merck.com.
17
MSD, Building A, Headquarters Park Phase 2, 1582 Gumei Road, Xuhui District, 200233, Shanghai, China. Electronic address: jun.ge@merck.com.
18
MSD, One Merck Campus Beijing, 100012, Beijing, Beijing, China. Electronic address: Jianfeng.li@merck.com.
19
MSD, One Merck Campus Beijing, 100012, Beijing, Beijing, China. Electronic address: hai.yan.wu1@merck.com.
20
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Kidney Cancer and Melanoma, Peking University Cancer Hospital & Institute, 52# Fucheng Road, Haidian District, 100142, Beijing, China. Electronic address: guoj307@126.com.

Abstract

BACKGROUND:

Pembrolizumab shows robust antitumor activity and favorable safety in metastatic melanoma. KEYNOTE-151 evaluated pembrolizumab in Chinese patients, who have more aggressive melanoma subtypes than other populations.

METHODS:

Chinese patients aged ≥18 years with advanced melanoma previously treated with one line of therapy received pembrolizumab 2 mg/kg every 3 weeks for 35 cycles or until confirmed disease progression, intolerable toxicity, or study withdrawal. Primary end points were objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review and safety. Key secondary end points included duration of response (DOR) and progression-free survival (PFS) per RECIST v1.1 and overall survival (OS).

RESULTS:

Median age was 52 years (N = 103); 37.9% had acral and 14.6% had mucosal melanoma. Median follow-up was 7.9 months at data cutoff (December 27, 2017). ORR was 16.7% [95% confidence internal (CI), 10.0%-25.3%] (1 complete, 16 partial responses). Disease control rate was 38.2%. ORR was 15.8% for acral and 13.3% for mucosal melanoma. Median DOR was 8.4 months; 65.6% of patients had response duration ≥6 months. Median PFS was 2.8 months (95% CI, 2.7-3.5 months); 6-month rate was 20.4%. Median OS was 12.1 months (95% CI, 9.6 months-not reached); 6-month rate, 75.7%; and 12-month rate, 50.6%. Treatment-related AEs (TRAEs) occurred in 87 (84.5%) patients; 9 (8.7%) experienced grade 3/4 TRAE and 2 (1.9%) discontinued because of TRAE; none died. Two deaths occurred that were unrelated to treatment.

CONCLUSIONS:

Pembrolizumab was well tolerated and provided clinically meaningful antitumor activity as second-line therapy in Chinese patients with advanced melanoma.

PMID:
30981094
DOI:
10.1016/j.tranon.2019.02.007
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