Pembrolizumab Treatment Of Advanced Cervical Cancer: Updated Results From The Phase 2 Keynote-158 Study

5522Background: The KEYNOTE-158 study (NCT02628067) is a phase II basket study investigating the antitumor activity of pembrolizumab, an IgG4 anti-PD-1 monoclonal antibody, in 11 cancer types. An updated analysis of all 98 patients (pts) included in the cervical cancer cohort is presented. Methods: Key eligibility criteria for this cohort included histologically or cytologically confirmed advanced cervical cancer, progression on or intolerance to ≥1 line of standard therapy, ECOG PS 0 or 1, and provision of a tumor sample for biomarker analysis. Pts received pembrolizumab 200 mg Q3W for 2 y or until progression, intolerable toxicity, or physician or patient decision. Tumor imaging was performed every 9 wks for the first 12 mo, and every 12 wks thereafter. PD-L1 positivity, defined as a combined positive score (CPS) ≥1, was evaluated retrospectively by IHC. Primary endpoint was ORR assessed per RECIST v1.1 by independent central radiology review. Secondary endpoints included DOR, PFS, OS, and safety. Resul...