Talimogene laherparepvec

Talimogene laherparepvec
Transmission electron micrograph of an unmodified herpes simplex virus
Gene therapy
Target geneGM-CSF
VectorHerpes simplex virus 1
Clinical data
Trade namesImlygic, Oncovex
Other namesT-Vec
AHFS/Drugs.comMonograph
MedlinePlusa616006
License data
Pregnancy
category
  • Contraindicated
Routes of
administration		Injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Talimogene laherparepvec, sold under the brand name Imlygic among others, is a biopharmaceutical medication used to treat melanoma that cannot be operated on; it is injected directly into a subset of lesions which generates a systemic immune response against the recipient's cancer.[5] The final four year analysis from the pivotal phase 3 study upon which TVEC was approved by the FDA showed a 31.5% response rate with a 16.9% complete response (CR) rate. There was also a substantial and statistically significant survival benefit in patients with earlier metastatic disease (stages IIIb-IVM1a) and in patients who hadn't received prior systemic treatment for melanoma. The earlier stage group had a reduction in the risk of death of approximately 50% with one in four patients appearing to have met, or be close to be reaching, the medical definition of cure.[6] Real world use of talimogene laherparepvec have shown response rates of up to 88.5% with CR rates of up to 61.5%.[7]

Around half of people treated with talimogene laherparepvec in clinical trials experienced fatigue and chills; around 40% had fever, around 35% had nausea, and around 30% had flu-like symptoms as well as pain at the injection site. The reactions were mild to moderate in severity; 2% of people had severe reactions and these were generally cellulitis.[8]

Talimogene laherparepvec is a genetically engineered herpes virus (an oncolytic herpes virus). Two genes were removed – one that shuts down an individual cell's defenses, and another that helps the virus evade the immune system – and a gene for human GM-CSF was added. The drug works by replicating in cancer cells, causing them to burst; it was also designed to stimulate an immune response against the patient's cancer, which has been demonstrated by multiple pieces of data, including regression of tumors which have not been injected with talimogene laherparepvec.[9][5]

The drug was created and initially developed by BioVex, Inc. and was continued by Amgen, which acquired BioVex in 2011.[10] It was one of the first oncolytic immunotherapy approved globally; it was approved in the US in October 2015 and approved in Europe in December 2015.[11][9][12]

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ Cite error: The named reference Imlygic FDA label was invoked but never defined (see the help page).
  3. ^ "Imlygic (talimogene laherparepvec)". U.S. Food and Drug Administration. 6 July 2022. Retrieved 19 November 2022.
  4. ^ "Imlygic EPAR". European Medicines Agency (EMA). 16 December 2015. Retrieved 26 August 2024.
  5. ^ a b Cite error: The named reference Fukuhara2016rev was invoked but never defined (see the help page).
  6. ^ Andtbacka RH, Collichio F, Harrington KJ, Middleton MR, Downey G, Öhrling K, et al. (June 2019). "Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma". Journal for Immunotherapy of Cancer. 7 (1): 145. doi:10.1186/s40425-019-0623-z. PMC 6554874. PMID 31171039.
  7. ^ Franke V, Berger DM, Klop WM, van der Hiel B, van de Wiel BA, Ter Meulen S, et al. (August 2019). "High response rates for T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a)". International Journal of Cancer. 145 (4): 974–978. doi:10.1002/ijc.32172. PMID 30694555. S2CID 59340728.
  8. ^ Cite error: The named reference EMAlabel was invoked but never defined (see the help page).
  9. ^ a b Cite error: The named reference Evans2016rev was invoked but never defined (see the help page).
  10. ^ "Amgen to Buy BioVex, Maker of Cancer Drugs". Bloomberg News via The New York Times. 24 January 2011.
  11. ^ "FDA approves Amgen's Injected Immunotherapy for Melanoma". Reuters. 27 October 2015.
  12. ^ "Imlygic (talimogene laherparepvec)". U.S. Food and Drug Administration (FDA). 1 March 2018. Archived from the original on 23 April 2019. Retrieved 1 April 2020.{{cite web}}: CS1 maint: unfit URL (link)