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An exploratory subgroup analysis of East Asian (EA) patients in a phase III trial was conducted to assess efficacy and safety trends based on ethnicity.The 795 patients with recurrent or metastatic squamous cell carcinoma of the head and neck included 111 EA patients randomized to pemetrexed-cisplatin (n = 55) and placebo-cisplatin (n = 56) and 684 non- EA patients randomized to pemetrexed-cisplatin (n = 343) and placebo-cisplatin (n = 341). Treatment differences in median overall survival and progression-free survival were compared using a stratified log-rank test. Survival was estimated using the Kaplan-Meier method.The median overall survival in the pemetrexed-cisplatin and placebo-cisplatin arms of the EA group (6.8 and 5.7 months, respectively [P = 0.275]) was similar to that in the global population (7.3 and 6.3 months, respectively [P = 0.082]); the median progression-free survival in the pemetrexed-cisplatin and placebo-cisplatin arms in the EA group (2.8 and 1.9 months, respectively [P = 0.748]) was similar to that in the global population (3.6 and 2.8 months, respectively [P = 0.166]). Compared to the findings in the global population, overall survival for the EA group receiving prior platinum-based therapy was longer (P = 0.042 vs P = 0.065). There was no significant interaction between treatment arms and ethnicity.Consistent with findings in the global population, pemetrexed-cisplatin did not improve survival compared with placebo-cisplatin for the EA group. However, in a subgroup analysis, pemetrexed-cisplatin showed an overall survival advantage in EA patients receiving prior platinum-based therapy.