Pembrolizumab or pembrolizumab plus chemotherapy versus standard of care chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062

Hironaga Satake; Keun-Wook Lee; Hyun Cheol Chung; Jeeyun Lee; Kensei Yamaguchi; Jen-Shi Chen; Takaki Yoshikawa; Kenji Amagai; Kun-Huei Yeh; Masahiro Goto; Yee Chao; Ka-On Lam; Shi Rong Han; Shinichi Shiratori; Sukrut Shah; Kohei Shitara

doi:10.1093/jjco/hyac188

Pembrolizumab or pembrolizumab plus chemotherapy versus standard of care chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062

Jpn J Clin Oncol. 2023 Mar 7;53(3):221-229. doi: 10.1093/jjco/hyac188.

Authors

Hironaga Satake¹, Keun-Wook Lee², Hyun Cheol Chung³, Jeeyun Lee⁴, Kensei Yamaguchi⁵, Jen-Shi Chen⁶, Takaki Yoshikawa⁷, Kenji Amagai⁸, Kun-Huei Yeh⁹, Masahiro Goto¹⁰, Yee Chao¹¹, Ka-On Lam¹², Shi Rong Han¹³, Shinichi Shiratori¹³, Sukrut Shah¹⁴, Kohei Shitara^{15

16}

Affiliations

¹ Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe City, Japan and Department of Medical Oncology, Kochi Medical School, Kochi, Japan.
² Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
³ Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
⁴ Division of Hematology/Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea.
⁵ Department of Gastroenterological Chemotherapy, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
⁶ Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan and College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.
⁷ Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.
⁸ Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Ibaraki, Japan.
⁹ Department of Oncology, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
¹⁰ Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
¹¹ Department of Oncology, Taipei Veterans General Hospital, Taipei City, Taiwan.
¹² Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.
¹³ Department of Medical Oncology, MSD K.K., Tokyo, Japan.
¹⁴ Department of Medical Oncology, Merck & Co., Inc., Rahway, NJ, USA.
¹⁵ Department of Gastrointestinal Oncology, National Cancer Center Hospital, Kashiwa, Japan.
¹⁶ Department of Immunology, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Abstract

Objective: First-line pembrolizumab with/without chemotherapy versus chemotherapy was evaluated in programmed death ligand 1 combined positive score ≥1, locally advanced/unresectable or metastatic gastric cancer/gastrooesophageal junction cancer in the KEYNOTE-062 study. We present results for patients enrolled in Asia.

Methods: Eligible patients were randomly assigned 1:1:1 to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin + 5-fluorouracil or capecitabine) or placebo plus chemotherapy Q3W. End points included overall survival (primary) in combined positive score ≥1 and combined positive score ≥10 populations and safety and tolerability (secondary).

Results: A total of 187 patients were enrolled in Asia (pembrolizumab, n = 62; pembrolizumab plus chemotherapy, n = 64; chemotherapy, n = 61). Compared with the global population, higher proportions of patients had Eastern Cooperative Oncology Group performance status 0 and a diagnosis of stomach cancer. In the programmed death ligand 1 combined positive score ≥1 population, median overall survival was numerically longer with pembrolizumab versus chemotherapy (22.7 vs 13.8 months; hazard ratio, 0.54; 95% confidence interval, 0.35-0.82) and pembrolizumab plus chemotherapy versus chemotherapy (16.5 vs 13.8 months; hazard ratio, 0.78; 95% confidence interval, 0.53-1.16). In the programmed death ligand 1 combined positive score ≥10 population, median overall survival was also numerically longer with pembrolizumab versus chemotherapy (28.5 vs 14.8 months; hazard ratio, 0.43; 95% confidence interval, 0.21-0.89) and pembrolizumab plus chemotherapy versus chemotherapy (17.5 vs 14.8 months; hazard ratio, 0.86; 95% confidence interval, 0.45-1.64). The grade 3-5 treatment-related adverse event rate was 19.4%, 75.8% and 64.9% for patients receiving pembrolizumab, pembrolizumab plus chemotherapy and chemotherapy, respectively.

Conclusions: This post hoc analysis showed pembrolizumab monotherapy was associated with numerically improved overall survival and a favourable tolerability profile versus chemotherapy in Asians with programmed death ligand 1-positive advanced gastric cancer/gastrooesophageal junction cancer.This study is registered with ClinicalTrials.gov, NCT02494583.

Keywords: Asian patients; chemotherapy; gastric cancer; gastrooesophageal junction cancer; pembrolizumab.

Publication types

Randomized Controlled Trial

MeSH terms

Adenocarcinoma* / drug therapy
Adenocarcinoma* / pathology
Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
Asian
Cisplatin / therapeutic use
Esophagogastric Junction / pathology
Humans
Standard of Care*
Stomach Neoplasms* / drug therapy
Stomach Neoplasms* / pathology

Substances

Cisplatin
pembrolizumab

Supplementary concepts

Adenocarcinoma Of Esophagus

Associated data

ClinicalTrials.gov/NCT02494583

Grants and funding

Merck Sharp & Dohme LLC