• Roger B Cohen, Jean-Pierre Delord, Toshihiko Doi, Sarina A Piha-Paul, Stephen V Liu, Jill Gilbert, Alain P Algazi, Silvia Damian, Ruey-Long Hong, Christophe Le Tourneau, Daphne Day, Andrea Varga, Elena Elez, John Wallmark, Sanatan Saraf, Pradeep Thanigaimani, Jonathan Cheng, and Bhumsuk Keam.
• *University of Pennsylvania, Philadelphia, PA †Institut Claudius Regaud, Toulouse §§U900 INSERM Research Unit, Saint-Cloud ‡‡Institut Curie, Paris ##Gustave Roussy, Villejuif, France ‡National Cancer Center Hospital East, Chiba, Japan §The University of Texas MD Anderson Cancer Center, Houston, TX ∥Georgetown University Hospital, Washington, DC ¶Vanderbilt University School of Medicine, Nashville, TN #Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA **Fondazione IRCCS Istituto Nazionale dei Tumori Medical Oncology, Milan, Italy ††National Taiwan University Hospital, Taipei, Taiwan ∥∥Princess Margaret Cancer Centre ¶¶Ontario Institute for Cancer Research, Toronto, ON, Canada ***Vall d'Hebron Institute of Oncology, Barcelona, Spain †††Maryland Oncology Hematology PA, Rockville, MD ‡‡‡Merck & Co. Inc., Kenilworth, NJ §§§Seoul National University Hospital, Seoul, Republic of Korea.
• Am. J. Clin. Oncol. 2018 Nov 1; 41 (11): 1083-1088.

ObjectivesTreatment options for patients with unresectable or metastatic salivary gland carcinoma (SGC) are limited. Safety and efficacy of pembrolizumab for SGC expressing programmed death ligand 1 (PD-L1) were explored.Materials And MethodsA cohort of patients with advanced, PD-L1-positive SGC was enrolled in the nonrandomized, multicohort, phase Ib trial of pembrolizumab in patients with PD-L1-positive advanced solid tumors (KEYNOTE-028; NCT02054806). Key inclusion criteria included recurrent or metastatic disease, failure of prior systemic therapy, and PD-L1 expression on ≥1% of tumor or stroma cells (per a prototype immunohistochemistry assay). Patients received pembrolizumab 10 mg/kg every 2 weeks for ≥2 years or until confirmed disease progression or unacceptable toxicity. Primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by investigator review.ResultsTwenty-six patients with PD-L1-positive SGC were enrolled and treated; median age was 57 years, 88% were men, and 74% had received prior therapy for recurrent/metastatic disease. Confirmed objective response rate after median follow-up of 20 months was 12% (95% confidence interval, 2%-30%), with 3 patients achieving partial response; there were no complete responses. Median duration of response was 4 months (range, 4 to 21 mo). Treatment-related adverse events occurred in 22 patients (85%), resulting in discontinuation in 2 patients and death in 1 (interstitial lung disease); those occurring in ≥15% of patients were diarrhea, decreased appetite, pruritus, and fatigue.ConclusionsPembrolizumab demonstrated promising antitumor activity and a manageable safety profile in patients with advanced, PD-L1-positive SGC.

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