Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study.

ABSTRACT:

Background

The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented.

Methods

Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/m² on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/m² on days 1-5 of each 3-week cycle (or capecitabine 1000 mg/m² twice daily in Japan). Primary end points were safety (combination therapy) and objective r

SUBMITTER: Bang YJ 

PROVIDER: S-EPMC6570680 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature