• Patrick A Ott, Yung-Jue Bang, Dominique Berton-Rigaud, Elena Elez, Michael J Pishvaian, Hope S Rugo, Igor Puzanov, Janice M Mehnert, Kyaw L Aung, Juanita Lopez, Marion Carrigan, Sanatan Saraf, Mei Chen, and Jean-Charles Soria.
• Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; Michael J. Pishvaian, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Hope S. Rugo, University of California San Francisco, San Francisco, CA; Igor Puzanov, Roswell Park Cancer Institute, Buffalo, NY; Janice M. Mehnert, Rutgers Cancer Institute of New Jersey, New Brunswick; Marion Carrigan, Sanatan Saraf, and Mei Chen, Merck, Kenilworth, NJ; Yung-Jue Bang, Seoul National University College of Medicine, Seoul, Republic of Korea; Dominique Berton-Rigaud, Institut de Cancérologie de l'Ouest Centre René Gauducheau, Saint-Herblain; Jean-Charles Soria, Gustave Roussy and University Paris-Sud, Villejuif, France; Elena Elez, Vall d'Hebron Institute of Oncology, Barcelona, Spain; Kyaw L. Aung, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; and Juanita Lopez, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom.
• J. Clin. Oncol. 2017 Aug 1; 35 (22): 2535-2541.

AbstractPurpose The multicohort phase Ib KEYNOTE-028 (NCT02054806) study was designed to evaluate the safety and efficacy of pembrolizumab, an anti-programmed death 1 monoclonal antibody, in patients with programmed death ligand 1 (PD-L1) -positive advanced solid tumors. The results from the advanced endometrial cancer cohort are reported. Patients and Methods Female patients with locally advanced or metastatic PD-L1-positive endometrial cancer who had experienced progression after standard therapy were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks for up to 24 months or until progression or unacceptable toxicity. Primary efficacy end point was objective response rate by RECIST (version 1.1). Secondary end points included safety, duration of response (DOR), progression-free survival, and overall survival. The data cutoff was February 17, 2016. Results Of 75 patients screened, 36 (48.0%) had PD-L1-positive tumors, and 24 (32.0%) were enrolled. Fifteen (62.5%) of these 24 patients had received at least two previous lines of therapy for advanced disease. Three patients (13.0%) achieved confirmed partial response (95% CI, 2.8% to 33.6%); the median DOR was not reached. Two patients were still receiving treatment and exhibiting continued response at time of data cutoff. Three additional patients (13.0%) achieved stable disease, with a median duration of 24.6 weeks. One patient who achieved partial response had a polymerase E mutation. Thirteen patients (54.2%) experienced treatment-related adverse events (AEs), with fatigue (20.8%), pruritus (16.7%), pyrexia (12.5%), and decreased appetite (12.5%) occurring in ≥ 10% of patients. Grade 3 treatment-related AEs were reported in four patients. No patient experienced a grade 4 AE, and no patient discontinued treatment because of an AE. Conclusion Pembrolizumab demonstrated a favorable safety profile and durable antitumor activity in a subgroup of patients with heavily pretreated advanced PD-L1-positive endometrial cancer.

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