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Background: Treatment options for R/M NPC are limited. In the phase Ib KEYNOTE-028 trial, pembro showed antitumor activity and manageable safety in a cohort of 27 patients (pts) with R/M NPC. KEYNOTE-122 (NCT02611960) is a multicenter, openlabel, randomized phase III study to evaluate the efficacy and safety of pembro monotherapy vs chemo in pts with platinum-pretreated, R/M NPC.Methods: Pts with histologically confirmed non-keratinizing differentiated (WHO Class II) or undifferentiated (WHO Class III), platinum-pretreated, Epstein-Barr Virus positive R/M NPC, ECOG PS 0-1, and measurable disease per RECIST v1.1 were randomized 1:1 to pembro 200 mg Q3W for up to 35 cycles or investigator's choice of standard doses of chemo (capecitabine [C], gemcitabine [G], or docetaxel [D]). Primary endpoint was OS (overall significance threshold: 0.025, one-sided). Secondary endpoints included PFS, ORR, and DOR (all per RECIST v1.1 by BICR).

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