Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients

Chung HC 1 , Kang YK 2 , Chen Z 3 , Bai Y 4 , Wan Ishak WZ 5 , Shim BY 6 Show all authors , Park YL 7 , Koo DH 8 , Lu J 9 , Xu J 10 , Chon HJ 11 , Bai LY 12 , Zeng S 13 , Yuan Y 14 , Chen YY 15 , Gu K 3 , Zhong WY 16 , Kuang S 17 , Shih CS 18 , Qin SK 19

Affiliations 

  • 1 Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea
  • 2 Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
  • 3 Hospital of Anhui Medical University, Hefei, China
  • 4 Harbin Medical University Cancer Hospital, Harbin, China
  • 5 Clinical Oncology Unit, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia
  • 6 St. Vincent's Hospital, The Catholic University of Korea, Gyeonggi-Do, South Korea
  • 7 National Cancer Center, Goyang-si, South Korea
  • 8 Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
  • 9 Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China
  • 10 The People's Liberation Army General Hospital, Beijing, China
  • 11 CHA Bundang Medical Center, Seongnam, South Korea
  • 12 China Medical University Hospital and China Medical University, Taichung, Taiwan
  • 13 Xiangya Hospital, Central South University, Changsha, China
  • 14 Department of Medical Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
  • 15 Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
  • 16 MSD China, Shanghai, China
  • 17 MSD China, Beijing, China
  • 18 Merck & Co., Inc., Kenilworth, New Jersey
  • 19 People's Liberation Army Cancer Centre of Nanjing Bayi Hospital, Nanjing, China
Cancer, 2022 Mar 01;128(5):995-1003.
PMID: 34878659 DOI: 10.1002/cncr.34019

Abstract

BACKGROUND: KEYNOTE-063 (NCT03019588) investigated pembrolizumab versus paclitaxel as second-line therapy in Asian patients with advanced programmed death ligand 1 (PD-L1)-positive (combined positive score ≥1) gastric/gastroesophageal junction (GEJ) cancer.

METHODS: This randomized, open-label, phase 3 study was conducted at 36 medical centers in China (mainland), Malaysia, South Korea, and Taiwan. Patients were randomly assigned 1:1 to 200 mg of pembrolizumab intravenously every 3 weeks for ≤2 years or 80 mg/m2 of paclitaxel intravenously every week. Primary end points were overall survival (OS) and progression-free survival (PFS). Secondary end points were objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 and safety.

RESULTS: Between February 16, 2017, and March 12, 2018, 94 patients were randomly assigned (47 pembrolizumab/47 paclitaxel) after screening; enrollment was stopped on March 12, 2018, based on the results of the global KEYNOTE-061 study, and patients were followed until the last patient's last visit. Median OS was 8 months (95% confidence interval [CI], 4-10 months) with pembrolizumab versus 8 months (95% CI, 5-11 months) with paclitaxel (hazard ratio [HR], 0.99; 95% CI, 0.63-1.54). Median PFS was 2 months (95% CI, 1-3 months) with pembrolizumab versus 4 months (95% CI, 3-6 months) with paclitaxel (HR, 1.62; 95% CI, 1.04-2.52). ORR was 13% for pembrolizumab versus 19% for paclitaxel. Any-grade treatment-related adverse events occurred in 28 pembrolizumab-treated patients (60%) and 42 paclitaxel-treated patients (96%); grades 3 to 5 events occurred in 5 patients (11%) and 28 patients (64%), respectively.

CONCLUSIONS: Definitive conclusions about the efficacy of second-line pembrolizumab in Asian patients with advanced PD-L1-positive gastric/GEJ cancer are limited because of insufficient power, but pembrolizumab was well tolerated in this patient population. Efficacy followed a trend similar to that observed in the phase 3 KEYNOTE-061 trial.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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