KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer

Ken Kato; Manish A. Shah; Peter Enzinger; Jaafar Bennouna; Lin Shen; Antoine Adenis; Jong Mu Sun; Byoung Chul Cho; Mustafa Özgüroǧlu; Takashi Kojima; Vladimir Kostorov; Cinta Hierro; Ying Zhu; Lee Anne McLean; Sukrut Shah; Toshihiko Doi

doi:10.2217/fon-2018-0609

KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer

Ken Kato, Manish A. Shah, Peter Enzinger, Jaafar Bennouna, Lin Shen, Antoine Adenis, Jong Mu Sun, Byoung Chul Cho, Mustafa Özgüroǧlu, Takashi Kojima, Vladimir Kostorov, Cinta Hierro, Ying Zhu, Lee Anne McLean, Sukrut Shah, Toshihiko Doi

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

101 Citations (Scopus)

Abstract

Treatment options for patients with advanced esophageal or esophagogastric junction (EGJ) cancer are limited. Current guidelines for first-line treatment of advanced esophageal or EGJ cancer recommend chemotherapy containing a platinum and a fluoropyrimidine agent. Pembrolizumab demonstrated antitumor activity in previously treated patients with advanced esophageal cancer and in patients with gastroesophageal junction cancer. Aim: To describe the design and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-590 study, which will be conducted to investigate pembrolizumab in combination with chemotherapy as first-line treatment in patients with advanced esophageal or EGJ cancer. Clinical trial registry & ID: ClinicalTrials.gov: NCT03189719.

Original language	English
Pages (from-to)	1057-1066
Number of pages	10
Journal	Future Oncology
Volume	15
Issue number	10
DOIs	https://doi.org/10.2217/fon-2018-0609
Publication status	Published - 2019 Apr

Bibliographical note

Funding Information:
This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. K Kato has received research funding from Merck Sharp & Dohme Corp., Merck Serono, ONO Pharmaceutical Co. Ltd and Shionogi, Inc. MA Shah has received research funding from Boston Biomedical, Inc., F Hoffmann-La Roche AG and Merck Sharp & Dohme Corp. P Enzinger has acted as an advisor for Astellas Pharma, Inc., BeiGene Co, Celgene Corp., Eli Lilly and Co., Five Prime Therapeutics, Inc. and Merck Sharp & Dohme Corp. J Bennouna has received honoraria from and acted as an advisor for AstraZeneca Plc, Boehringer-Ingelheim GmbH, F Hoffmann-La Roche AG, Merck Sharp & Dohme Corp. and Shire Plc. A Adenis has received honoraria from Bayer AG, Bristol-Myers Squibb and Sanofi SA; acted as an advisor for Bayer AG, Bristol-Myers Squibb and Servier Laboratories; received research funding from Bayer AG, Bristol-Myers Squibb, Merck Sharp & Dohme Corp., Pfizer, Inc. and Sanofi SA; and received travel, accommodation or expenses from Bayer AG, Bristol-Myers Squibb and Merck Sharp & Dohme Corp. JM Sun has acted as an advisor for Boehringer-Ingelheim GmbH and received research funding from AstraZeneca Plc. BC Cho has received honoraria and acted as an advisor for AstraZeneca Plc, Boehringer-Ingelheim GmbH, Bristol-Myers Squibb, F Hoffmann-La Roche AG, Merck Sharp & Dohme Corp., Novartis International AG and Yuhan Co. Ltd; served on speaker bureaus for AstraZeneca Plc, Bristol-Myers Squibb, Merck Sharp & Dohme Corp. and Novartis International AG; and received research funding from AstraZeneca Plc, Bayer AG, Novartis International AG and Yuhan Co. Ltd. M Ozguroglu has received honoraria from Janssen Pharmaceutica NV and acted as an advisor for Astellas Pharma, Inc. and Janssen Pharmaceutica NV. T Kojima has received honoraria from Oncolys Biopharma, Inc. and has intellectual property interests in Amgen, Inc., Astellas Pharma, Inc., Merck Sharp & Dohme Corp., Oncolys Biopharma, Inc., ONO Pharmaceutical Co. Ltd and Shionogi, Inc. Y Zhu, LA McLean and S Shah are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. LA McLean and S Shah own stock in the company. T Doi has acted as an advisor for Amgen Inc., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Kyowa Hakko Kirin Co. Ltd, Eli Lilly Japan KK, Merck Sharp & Dohme Corp. and Novartis International AG; and received research funding from Astellas Pharma, Inc., Bayer AG, Boehringer Ingelheim GmbH, Celgene Corp., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Janssen Pharmaceutica NV, Kyowa Hakko Kirin Co. Ltd, Eli Lilly Japan KK, Merck Serono, Merck Sharp & Dohme Corp., Novartis International AG, Pfizer, Inc., Sumitomo Corp., Taiho Pharmaceutical Co. Ltd and Takeda Pharmaceutical Co. Ltd. C Hierro has received research funding from Bayer and lecture fees and travel grants from Lilly, Ignyta and Roche. L Shen and V Kostorov report no conflicts of interest. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Publisher Copyright:
© 2019 2019 Future Medicine Ltd.

All Science Journal Classification (ASJC) codes

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.2217/fon-2018-0609

Cite this

Kato, K., Shah, M. A., Enzinger, P., Bennouna, J., Shen, L., Adenis, A., Sun, J. M., Cho, B. C., Özgüroǧlu, M., Kojima, T., Kostorov, V., Hierro, C., Zhu, Y., McLean, L. A., Shah, S., & Doi, T. (2019). KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncology, 15(10), 1057-1066. https://doi.org/10.2217/fon-2018-0609

@article{2940d087656e4e7886367807ce57b55e,

title = "KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer",

abstract = "Treatment options for patients with advanced esophageal or esophagogastric junction (EGJ) cancer are limited. Current guidelines for first-line treatment of advanced esophageal or EGJ cancer recommend chemotherapy containing a platinum and a fluoropyrimidine agent. Pembrolizumab demonstrated antitumor activity in previously treated patients with advanced esophageal cancer and in patients with gastroesophageal junction cancer. Aim: To describe the design and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-590 study, which will be conducted to investigate pembrolizumab in combination with chemotherapy as first-line treatment in patients with advanced esophageal or EGJ cancer. Clinical trial registry & ID: ClinicalTrials.gov: NCT03189719.",

author = "Ken Kato and Shah, {Manish A.} and Peter Enzinger and Jaafar Bennouna and Lin Shen and Antoine Adenis and Sun, {Jong Mu} and Cho, {Byoung Chul} and Mustafa {\"O}zg{\"u}roǧlu and Takashi Kojima and Vladimir Kostorov and Cinta Hierro and Ying Zhu and McLean, {Lee Anne} and Sukrut Shah and Toshihiko Doi",

note = "Funding Information: This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. K Kato has received research funding from Merck Sharp & Dohme Corp., Merck Serono, ONO Pharmaceutical Co. Ltd and Shionogi, Inc. MA Shah has received research funding from Boston Biomedical, Inc., F Hoffmann-La Roche AG and Merck Sharp & Dohme Corp. P Enzinger has acted as an advisor for Astellas Pharma, Inc., BeiGene Co, Celgene Corp., Eli Lilly and Co., Five Prime Therapeutics, Inc. and Merck Sharp & Dohme Corp. J Bennouna has received honoraria from and acted as an advisor for AstraZeneca Plc, Boehringer-Ingelheim GmbH, F Hoffmann-La Roche AG, Merck Sharp & Dohme Corp. and Shire Plc. A Adenis has received honoraria from Bayer AG, Bristol-Myers Squibb and Sanofi SA; acted as an advisor for Bayer AG, Bristol-Myers Squibb and Servier Laboratories; received research funding from Bayer AG, Bristol-Myers Squibb, Merck Sharp & Dohme Corp., Pfizer, Inc. and Sanofi SA; and received travel, accommodation or expenses from Bayer AG, Bristol-Myers Squibb and Merck Sharp & Dohme Corp. JM Sun has acted as an advisor for Boehringer-Ingelheim GmbH and received research funding from AstraZeneca Plc. BC Cho has received honoraria and acted as an advisor for AstraZeneca Plc, Boehringer-Ingelheim GmbH, Bristol-Myers Squibb, F Hoffmann-La Roche AG, Merck Sharp & Dohme Corp., Novartis International AG and Yuhan Co. Ltd; served on speaker bureaus for AstraZeneca Plc, Bristol-Myers Squibb, Merck Sharp & Dohme Corp. and Novartis International AG; and received research funding from AstraZeneca Plc, Bayer AG, Novartis International AG and Yuhan Co. Ltd. M Ozguroglu has received honoraria from Janssen Pharmaceutica NV and acted as an advisor for Astellas Pharma, Inc. and Janssen Pharmaceutica NV. T Kojima has received honoraria from Oncolys Biopharma, Inc. and has intellectual property interests in Amgen, Inc., Astellas Pharma, Inc., Merck Sharp & Dohme Corp., Oncolys Biopharma, Inc., ONO Pharmaceutical Co. Ltd and Shionogi, Inc. Y Zhu, LA McLean and S Shah are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. LA McLean and S Shah own stock in the company. T Doi has acted as an advisor for Amgen Inc., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Kyowa Hakko Kirin Co. Ltd, Eli Lilly Japan KK, Merck Sharp & Dohme Corp. and Novartis International AG; and received research funding from Astellas Pharma, Inc., Bayer AG, Boehringer Ingelheim GmbH, Celgene Corp., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Janssen Pharmaceutica NV, Kyowa Hakko Kirin Co. Ltd, Eli Lilly Japan KK, Merck Serono, Merck Sharp & Dohme Corp., Novartis International AG, Pfizer, Inc., Sumitomo Corp., Taiho Pharmaceutical Co. Ltd and Takeda Pharmaceutical Co. Ltd. C Hierro has received research funding from Bayer and lecture fees and travel grants from Lilly, Ignyta and Roche. L Shen and V Kostorov report no conflicts of interest. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} 2019 2019 Future Medicine Ltd.",

year = "2019",

month = apr,

doi = "10.2217/fon-2018-0609",

language = "English",

volume = "15",

pages = "1057--1066",

journal = "Future Oncology",

issn = "1479-6694",

publisher = "Future Medicine Ltd.",

number = "10",

}

Kato, K, Shah, MA, Enzinger, P, Bennouna, J, Shen, L, Adenis, A, Sun, JM, Cho, BC, Özgüroǧlu, M, Kojima, T, Kostorov, V, Hierro, C, Zhu, Y, McLean, LA, Shah, S & Doi, T 2019, 'KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer', Future Oncology, vol. 15, no. 10, pp. 1057-1066. https://doi.org/10.2217/fon-2018-0609

TY - JOUR

T1 - KEYNOTE-590

T2 - Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer

AU - Kato, Ken

AU - Shah, Manish A.

AU - Enzinger, Peter

AU - Bennouna, Jaafar

AU - Shen, Lin

AU - Adenis, Antoine

AU - Sun, Jong Mu

AU - Cho, Byoung Chul

AU - Özgüroǧlu, Mustafa

AU - Kojima, Takashi

AU - Kostorov, Vladimir

AU - Hierro, Cinta

AU - Zhu, Ying

AU - McLean, Lee Anne

AU - Shah, Sukrut

AU - Doi, Toshihiko

N1 - Funding Information: This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. K Kato has received research funding from Merck Sharp & Dohme Corp., Merck Serono, ONO Pharmaceutical Co. Ltd and Shionogi, Inc. MA Shah has received research funding from Boston Biomedical, Inc., F Hoffmann-La Roche AG and Merck Sharp & Dohme Corp. P Enzinger has acted as an advisor for Astellas Pharma, Inc., BeiGene Co, Celgene Corp., Eli Lilly and Co., Five Prime Therapeutics, Inc. and Merck Sharp & Dohme Corp. J Bennouna has received honoraria from and acted as an advisor for AstraZeneca Plc, Boehringer-Ingelheim GmbH, F Hoffmann-La Roche AG, Merck Sharp & Dohme Corp. and Shire Plc. A Adenis has received honoraria from Bayer AG, Bristol-Myers Squibb and Sanofi SA; acted as an advisor for Bayer AG, Bristol-Myers Squibb and Servier Laboratories; received research funding from Bayer AG, Bristol-Myers Squibb, Merck Sharp & Dohme Corp., Pfizer, Inc. and Sanofi SA; and received travel, accommodation or expenses from Bayer AG, Bristol-Myers Squibb and Merck Sharp & Dohme Corp. JM Sun has acted as an advisor for Boehringer-Ingelheim GmbH and received research funding from AstraZeneca Plc. BC Cho has received honoraria and acted as an advisor for AstraZeneca Plc, Boehringer-Ingelheim GmbH, Bristol-Myers Squibb, F Hoffmann-La Roche AG, Merck Sharp & Dohme Corp., Novartis International AG and Yuhan Co. Ltd; served on speaker bureaus for AstraZeneca Plc, Bristol-Myers Squibb, Merck Sharp & Dohme Corp. and Novartis International AG; and received research funding from AstraZeneca Plc, Bayer AG, Novartis International AG and Yuhan Co. Ltd. M Ozguroglu has received honoraria from Janssen Pharmaceutica NV and acted as an advisor for Astellas Pharma, Inc. and Janssen Pharmaceutica NV. T Kojima has received honoraria from Oncolys Biopharma, Inc. and has intellectual property interests in Amgen, Inc., Astellas Pharma, Inc., Merck Sharp & Dohme Corp., Oncolys Biopharma, Inc., ONO Pharmaceutical Co. Ltd and Shionogi, Inc. Y Zhu, LA McLean and S Shah are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA. LA McLean and S Shah own stock in the company. T Doi has acted as an advisor for Amgen Inc., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Kyowa Hakko Kirin Co. Ltd, Eli Lilly Japan KK, Merck Sharp & Dohme Corp. and Novartis International AG; and received research funding from Astellas Pharma, Inc., Bayer AG, Boehringer Ingelheim GmbH, Celgene Corp., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Janssen Pharmaceutica NV, Kyowa Hakko Kirin Co. Ltd, Eli Lilly Japan KK, Merck Serono, Merck Sharp & Dohme Corp., Novartis International AG, Pfizer, Inc., Sumitomo Corp., Taiho Pharmaceutical Co. Ltd and Takeda Pharmaceutical Co. Ltd. C Hierro has received research funding from Bayer and lecture fees and travel grants from Lilly, Ignyta and Roche. L Shen and V Kostorov report no conflicts of interest. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2019 2019 Future Medicine Ltd.

PY - 2019/4

Y1 - 2019/4

N2 - Treatment options for patients with advanced esophageal or esophagogastric junction (EGJ) cancer are limited. Current guidelines for first-line treatment of advanced esophageal or EGJ cancer recommend chemotherapy containing a platinum and a fluoropyrimidine agent. Pembrolizumab demonstrated antitumor activity in previously treated patients with advanced esophageal cancer and in patients with gastroesophageal junction cancer. Aim: To describe the design and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-590 study, which will be conducted to investigate pembrolizumab in combination with chemotherapy as first-line treatment in patients with advanced esophageal or EGJ cancer. Clinical trial registry & ID: ClinicalTrials.gov: NCT03189719.

AB - Treatment options for patients with advanced esophageal or esophagogastric junction (EGJ) cancer are limited. Current guidelines for first-line treatment of advanced esophageal or EGJ cancer recommend chemotherapy containing a platinum and a fluoropyrimidine agent. Pembrolizumab demonstrated antitumor activity in previously treated patients with advanced esophageal cancer and in patients with gastroesophageal junction cancer. Aim: To describe the design and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-590 study, which will be conducted to investigate pembrolizumab in combination with chemotherapy as first-line treatment in patients with advanced esophageal or EGJ cancer. Clinical trial registry & ID: ClinicalTrials.gov: NCT03189719.

UR - http://www.scopus.com/inward/record.url?scp=85064212073&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85064212073&partnerID=8YFLogxK

U2 - 10.2217/fon-2018-0609

DO - 10.2217/fon-2018-0609

M3 - Article

C2 - 30735435

AN - SCOPUS:85064212073

SN - 1479-6694

VL - 15

SP - 1057

EP - 1066

JO - Future Oncology

JF - Future Oncology

IS - 10

ER -

KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this