title: Responses of metastatic basal cell and cutaneous squamous cell carcinomas to anti-PD1 monoclonal antibody REGN2810.
abstract: Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (CSCC) share exposure to UV light as the dominant risk factor, and these tumors therefore harbor high mutation burdens. In other malignancies, high mutation burden has been associated with clinical benefit from therapy with antibodies directed against the Programmed Death 1 (PD-1) immune checkpoint receptor. Highly mutated tumors are more likely to express immunogenic tumor neoantigens that attract effector T cells, which can be unleashed by blockade of the PD-1 immune checkpoint.
  
  
  
  This report describes a patient with metastatic BCC and a patient with metastatic CSCC who were treated with REGN2810, a fully human anti-PD-1 monoclonal antibody, in an ongoing phase 1 trial (NCT02383212). The CSCC patient has experienced an ongoing complete response (16+ months), and the BCC patient has experienced an ongoing partial response (12+ months).
  
  
  
  These case reports suggest that UV-associated skin cancers, beyond melanoma, are sensitive to PD-1 blockade.
  
  
  
  Clinicaltrials.gov NCT02383212. Registered 2 February 2015.
authors.affiliation: Sarah Cannon Research Institute at HealthONE, Denver, CO USA.
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Falchook
authors.affiliation: Department of Medicine, Providence Portland Medical Center, Portland, OR USA.
authors.forename: Rom
authors.initials: R
authors.lastname: Leidner
authors.affiliation: Oncology Clinical Sciences, Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707 USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Stankevich
authors.affiliation: Department of Pathology, Providence Portland Medical Center, Portland, OR USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Piening
authors.affiliation: Department of Pathology, Providence Portland Medical Center, Portland, OR USA.
authors.forename: Carlo
authors.initials: C
authors.lastname: Bifulco
authors.affiliation: Oncology Clinical Sciences, Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707 USA.
authors.forename: Israel
authors.initials: I
authors.lastname: Lowy
authors.affiliation: Oncology Clinical Sciences, Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707 USA.
authors.forename: Matthew G
authors.initials: MG
authors.lastname: Fury
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D000074322:Antineoplastic Agents, Immunological / Q000494:pharmacology / Q000627:therapeutic use*; D002280:Basal Cell Carcinoma / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D061026:Programmed Cell Death 1 Receptor / Q000037:antagonists & inhibitors*; D012878:Skin Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000074322:Antineoplastic Agents, Immunological; D061026:Programmed Cell Death 1 Receptor
keywords: Basal cell carcinoma; Cutaneous squamous cell carcinoma; Immune checkpoint inhibitor; Mutation burden; Phase 1; Programmed Death-1; REGN2810