Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: Interim results from the phase 2 KEYNOTE-100 study.

Abstract

5511Background: Data from the KEYNOTE-028 study (NCT02054806) suggested that pembrolizumab (pembro) has clinical activity in patients (pts) with PD-L1+ advanced ovarian cancer (AOC). We assessed the antitumor activity and safety of pembro in pts with recurrent AOC in the ongoing, 2-cohort, phase 2 KEYNOTE-100 study (NCT02674061). Methods: Key eligibility criteria included epithelial ovarian, fallopian tube, or primary peritoneal cancer, confirmed recurrence following front-line platinum-based therapy, ECOG PS 0/1, and provision of a tumor sample for biomarker analysis. Cohort A pts received ≤2 prior chemotherapy lines for recurrent AOC and had a platinum-free or treatment-free interval (PFI/TFI) of ≥3 to 12 mo. Cohort B pts received 3-5 prior chemotherapy lines and had a PFI/TFI of ≥3 mo. Pts received pembro 200 mg Q3W IV for 2 yrs or until progression, death, unacceptable toxicity, or consent withdrawal. Tumor imaging was performed every 9 wks for 1 yr and every 12 wks thereafter. Primary study endpoint ...