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Pembrolizumab plus 5-FU and Cisplatin for First-line Treatment in Advanced Gastric Cancer (KEYNOTE-059)
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Dr. Yung-Jue Bang discusses Pembrolizumab plus 5-FU and Cisplatin for First-line Treatment in Advanced Gastric Cancer (KEYNOTE-059) at ASCO 2017. For the ability to view on your mobile phone please visit us at

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Hello, I am Dr. Yung-Jue Bang from Seoul National University Hospital. On behalf of my co-authors, I am pleased to present research from Cohort 2 or phase two KEYNOTE-059 trial. This trial is investigating the efficacy and safety of pembrolizumab in combination with fluoropyrimidine and cisplatin as first line therapy in patient with advanced gastric or gastroesophageal junction cancer.

During the trial, patients received 200 milligrams pembrolizumab in combination with cisplatin and 5-fluorouracil every three weeks. The primary endpoint was safety, and secondary endpoint included objective response rate, progression-free survival, and overall survival. 25 patients were enrolled in this cohort at ten sites from March to December 2015. The patient population enrolled in Cohort two, 10 out of 59 was generally representative of the advanced gastric cancer population. 64 percent of patient had PD-L1 positive tumors, defined as combined positive score greater than or equal to 1.

The overall objective response rate was 60 percent. Among patients with PD-L1 positive tumors, it was 69 percent. This is one of our plots. One hundred percent of patients with measurable disease, and rest were post-baseline tumor assessment experienced a reduction in tumor size.

This figure shows progression-free survival in all patients. Median progression-free survival was 6.6 months. This figure shows overall survival in all patients. Median survival was 20.8 months. Median treatment exposure was 7.1 months. All 25 patients experienced 1 or more treatment-related adverse events. 76 percent of patients experienced grade three to four, treatment-related adverse events. And the most common tread, treatment-related event were neutropenia and stomatitis. Immune-mediated treatment-related adverse event occurred in 48 percent of patients and was low grade.

In conclusion, pembrolizumab in combination with cisplatin, fluoropyrimidine demonstrated encouraging efficacy in manageable safety as first line therapy in advanced gastric cancer. There were no treatment-related deaths. Responses were observed in patient with either PD-L1 negative or positive tumors. The results presented here support phase-three KEYNOTE-062 trial, which evaluates the efficacy and safety of first-line pembrolizumab as mono therapy, or in combination with chemo as compared to chemo alone in patients with treatment naive advanced gastric cancer.

Thank you for your attention.