title: Talimogene Laherparepvec: An Oncolytic Virus Therapy for Melanoma.
abstract: OBJECTIVE
  To review the efficacy and safety of talimogene laherparepvec (T-VEC) as well as its pharmacology, pharmacokinetics, drug-drug interactions, handling procedures, cost considerations, and place in therapy.
  
  
  METHODS
  Searches of PubMed (1966 to February 2017) and Cochrane Library (1999 to February 2017) were conducted using the terms talimogene laherparepvec, T-VEC, OncoVEX, immunotherapy, melanoma, and oncolytic virus. Additional information was determined from bibliographies, manufacturer product labeling and website, meeting abstracts, Food and Drug Administration website, and clinicaltrials.gov.
  
  
  METHODS
  A total of 79 English-language publications were identified. Articles that assessed T-VEC's pharmacokinetics, pharmacodynamics, mechanism, dosing, safety, and efficacy were included as well as narrative reviews that provided practical information.
  
  
  RESULTS
  Clinical trials have confirmed the safety and efficacy of T-VEC as monotherapy for the treatment of advanced melanoma, with an overall response rate (ORR) of 26%. Relative to granulocyte-macrophage colony-stimulating factor, T-VEC significantly increased durable response rate (DRR; 16.3% vs 2.1%, P < 0.001); however, median overall survival was not improved (23.3 vs 18.9 months, P = 0.051). Phase 1b trials have combined T-VEC and immunotherapies with promising results. T-VEC's adverse effects are generally considered mild to moderate in severity.
  
  
  CONCLUSIONS
  T-VEC is the first approved oncolytic virus for local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in melanoma recurrent after initial surgery. T-VEC improves ORR and DRR as a single agent, shows promise in combination therapy, and is well tolerated. Ongoing trials will determine if T-VEC has a role in early treatment or in combination therapy for melanoma or other malignancies.
authors.affiliation: 1 Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.|2 Virginia Commonwealth University School of Pharmacy, Richmond, VA, USA.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Corrigan
authors.affiliation: 1 Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.
authors.forename: Caroline
authors.initials: C
authors.lastname: Beaulieu
authors.affiliation: 1 Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.
authors.forename: Rashmi B
authors.initials: RB
authors.lastname: Patel
authors.affiliation: 1 Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.|2 Virginia Commonwealth University School of Pharmacy, Richmond, VA, USA.
authors.forename: Denise K
authors.initials: DK
authors.lastname: Lowe
mesh_terms: D000279:Administration, Cutaneous; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008545:Melanoma / Q000473:pathology / Q000628:therapy* / Q000821:virology; D050130:Oncolytic Virotherapy / Q000379:methods*; D050504:Oncolytic Viruses / Q000235:genetics
keywords: T-VEC; immunotherapy; melanoma; oncolytic virus; talimogene laherparepvec