Pembrolizumab may have a manageable toxicity profile and promising antitumor activity in patients with recurrent or metastatic PD-L1-positive gastric cancer, according to a study published in The Lancet Oncology.1

Researchers led by Kei Muro, MD, of the Aichi Cancer Center Hospital in Japan conducted a multicenter, open-label, phase 1b trial of 39 patients enrolled across 13 cancer research centers in the United States, Israel, Japan, South Korea, and Taiwan.

Patients had PD-L1-positive recurrent or metastatic adenocarcinoma of the stomach or gastro-esophageal junction and received intravenous pembrolizumab once every 2 weeks for 24 months or until progression or unacceptable toxic effects occurred. Response to treatment was assessed every 8 weeks in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1.

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Among the observed patients, 36 were evaluable for response by central assessment, and 8 of those patients were judged to have had an overall response at central review. All responses were found to be partial.

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All 39 patients were included in the safety analyses, and 5 patients were found to have a total of 6 grade 3 or 4 treatment-related adverse events that included grade 3 fatigue, hypothyroidism, and peripheral sensory neuropathy. There were no treatment-related deaths.


  1. Muro K, Chung HC, Shankaran V, et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial [published online ahead of print May 3, 2016]. The Lancet Oncol. doi: 10.1016/S1470-2045(16)00175-3.