Talimogene laherparepvec

Generic Name
Talimogene laherparepvec
Brand Names
Imlygic
Drug Type
Biotech
Chemical Formula
-
CAS Number
1187560-31-1
Unique Ingredient Identifier
07730V90L6
Background

Talimogene laherparepvec is an oncolytic treatment used in local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma. It is a genetically administered herpes simplex virus 1 (HSV-1) that expresses human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with antitumor and immune-stimulating activities. It specifically replicates within tumor cells and causes lysis. It was approved by the FDA in 2015 under the market name Imlygic.

In general, talimogene laherparepvec has been modified so that it can infect and multiply inside melanoma cells . The drug subsequently uses the melanoma cells' own machinery to multiply, eventually overwhelming the melanoma cells and killing them . Alternatively, although talimogene laherparepvec also enters healthy cells, it is not designed to multiply inside them .

Indication

This medication is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable, cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery . Elsewhere, the EMA notes that the agent is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral diseases .

Associated Conditions
Unresectable Skin Lesion
Associated Therapies
-

Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

First Posted Date
2014-11-21
Last Posted Date
2019-10-31
Lead Sponsor
Amgen
Registration Number
NCT02297529
Locations
🇨🇭

Research Site, Zürich, Switzerland

Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

First Posted Date
2014-10-13
Last Posted Date
2022-11-14
Lead Sponsor
Amgen
Target Recruit Count
713
Registration Number
NCT02263508
Locations
🇬🇧

Research Site, Southampton, United Kingdom

Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma

First Posted Date
2014-08-07
Last Posted Date
2023-06-05
Lead Sponsor
Amgen
Target Recruit Count
150
Registration Number
NCT02211131
Locations
🇨🇭

Research Site, Zürich, Switzerland

Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma

First Posted Date
2014-05-28
Last Posted Date
2016-03-01
Lead Sponsor
Amgen
Registration Number
NCT02147951
Locations
🇺🇸

Research Site, Wauwatosa, Wisconsin, United States

Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-12-18
Last Posted Date
2019-11-20
Lead Sponsor
Amgen
Target Recruit Count
61
Registration Number
NCT02014441
Locations
🇨🇦

Research Site, Montreal, Quebec, Canada

Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-12-04
Last Posted Date
2024-05-14
Lead Sponsor
Amgen
Target Recruit Count
217
Registration Number
NCT01740297
Locations
🇩🇪

Research Site, Tübingen, Germany

A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-02-09
Last Posted Date
2015-12-18
Lead Sponsor
BioVex Limited
Target Recruit Count
50
Registration Number
NCT00289016
Locations
🇺🇸

Mountainside Hospital, Montclair, New Jersey, United States

🇬🇧

Royal Marsden Hospital, London, United Kingdom

🇺🇸

UCLA, Los Angeles, California, United States

and more 5 locations
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