Safety of pembrolizumab in recurrent or advanced gastric cancer expressing PD-L1 refractory to platinum and fluoropyrimidine

ABSTRACT

Introduction

Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC).

Area covered

Pembrolizumab was approved by the US Food and Drug Administration in September 2017 as third-line or later treatment of AGC in patients positive for programmed death ligand 1 (PD-L1). In this article, we review the development of pembrolizumab, its pharmacology, and its safety profile as monotherapy in patients with PD-L1 positive previous treated AGC.

Expert opinion

Pembrolizumab has demonstrated durable response and acceptable safety profile in patients receiving two previous courses of systemic chemotherapy. It has become a treatment option in patients with AGC. Currently, there are several ongoing clinical trials of pembrolizumab in combination with cytotoxic chemotherapy or molecular targeting agents AGC.

KEYWORDS:

• Pembrolizumab
• immunotherapy
• gastric cancer
• immune-mediated adverse event
• safety

Box 1. Drug summary-pembrolizumab for gastric cancer

Table

Acknowledgments

The authors would like to thank Enago (www.enago.jp) for the English language review.

Declaration of interest

A. Kawazoe reports research funding from Ono, Sumitomo Dainippon, and Taiho. K. Shitara reports paid consulting or advisory roles for Astellas, Lilly, Bristol-Myers Squibb, Takeda, Pfizer, Ono, MSD, Taiho, Novartis, AbbVie, and GlaxoSmithKline; honoraria from Novartis, AbbVie, and Yakult; and research funding from Astellas, Lilly, Ono, Sumoitomo Dainippon, Daiichi Sankyo, Taiho, Chugai, MSD and Medi Science. 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A peer reviewer on this manuscript has received honorarium for advisory board and educational symposium from Bristol-Myers-Squibb, Astra-Zeneca, Servier, Roche, MSD and Bayer. All other peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.