Journal article
Safety and antitumor activity of pembrolizumab in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer
HS Rugo, JP Delord, SA Im, PA Ott, SA Piha-Paul, PL Bedard, J Sachdev, C Le Tourneau, EMJ van Brummelen, A Varga, R Salgado, S Loi, S Saraf, D Pietrangelo, V Karantza, AR Tan
Clinical Cancer Research | AMER ASSOC CANCER RESEARCH | Published : 2018
Abstract
Purpose: We investigated the safety and antitumor activity of the anti–programmed death 1 monoclonal antibody pembrolizumab in patients with estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer with programmed death ligand 1–positive (PD-L1–positive) tumors in the phase Ib open-label, multicohort KEYNOTE-028 (NCT02054806) study. Patients and Methods: Patients with ER+/HER2– advanced breast cancer with PD-L1–positive tumors (combined positive score ≥1) received pembrolizumab (10 mg/kg every 2 weeks) up to 2 years or until confirmed progression/intolerable toxicity. Primary endpoints were safety and overall response rate (ORR), based..
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Funding Acknowledgements
The authors thank the patients and their families, study investigators, and site personnel and Roger Dansey (Merck & Co., Inc., Kenilworth, NJ) for critical manuscript review. Medical writing and/or editorial assistance was provided by Sarita S. Shaevitz, PhD, and Amy McQuay, PhD, of the ApotheCom pembrolizumab team (Yardley, PA). This assistance was funded by Merck & Co., Inc., Kenilworth, NJ. Funding for this research was provided by Merck & Co., Inc., Kenilworth, NJ.