talimogene laherparepvec
Trade name: Imlygic
Approved
Oct 27, 2015
Talimogene laherparepvec (T-VEC), 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. The final four-year analysis from the pivotal phase 3 study upon which T-VEC 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 and in patients who had not 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. Real world use of talimogene laherparepvec have shown response rates of up to 88.5% with CR rates of up to 61.5%. — Wikipedia
Clinical trial activity
51 trials · 39 clinical orgs · 1 marketing orgs
Earliest trial started Dec 1, 2005 (NCT00289016)
Timeline
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 2
- Adenocarcinoma, Papillary · Phase 2
- Basal Cell Carcinoma · Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 2
- Carcinoma, Adenoid Cystic · Phase 2
- Carcinoma, Ductal · Phase 1/Phase 2
- Carcinoma, Hepatocellular · Phase 1
- Carcinoma, Merkel Cell · Phase 2
- Carcinoma, Signet Ring Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 3
- Carcinoma, Transitional Cell · Phase 1
- Colorectal Neoplasms · Phase 1
- Dermatology · Phase 2
- Hamartoma · Phase 1
- Head and Neck Neoplasms · Phase 3
- Keratoacanthoma · Phase 2
- Leiomyosarcoma · Phase 2
- Liposarcoma · Phase 2
- Liver Neoplasms · Phase 1
- Lung Neoplasms · Phase 1/Phase 2
- Lymph Nodes · Phase 1
- Lymphoma · Phase 2
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Melanoma · Phase 3
- Mutation · Phase 2
- Mycosis Fungoides · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 2
- Neoplasms, Adnexal and Skin Appendage · Phase 2
- Neurofibroma · Phase 1
- Neurofibromatoses · Phase 1
- Neurofibromatosis 1 · Phase 1
- Paget Disease, Extramammary · Phase 2
- Pancreatic Neoplasms · Phase 1
- Peritoneal Neoplasms · Phase 1
- Pleural Effusion, Malignant · Phase 1/Phase 2
- Sarcoma · Phase 2
- Sarcoma, Kaposi · Phase 2
- Sezary Syndrome · Phase 2
- Skin Neoplasms · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 1
- Vulvar Neoplasms · Phase 2
Mechanism of action
CSF2 activator
- Melanoma cellsDISRUPTING AGENT
Melanoma cells disrupting agent
Causes lysis of tumour cells.
Approval history
- approvedOct 27, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaTalimogene laherparepvec ↗
- NCATS07730V90L6 ↗
- ChEMBLCHEMBL2108727 ↗
Also known as
- imlygic
- imlygic
- imlygic
- js1 34.5-hgmcsf 47- pa-
- js1 34.5-hgmcsf 47- pa-
- js1 34.5-hgmcsf 47-pa-
- oncovex
- talimogene laherparep
- talimogene laherparepvec
- talimogene laherparepvec
- talimogene laherparepvec
- talimogene laherparepvec
- talimogene laherparepvec
- talimogene laherparepvec
- talimogene laherparepvec
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07102394 | Phase 1 | Feb 1, 2026 | Amgen, Johns Hopkins University |
| NCT06660810 | Early Phase 1 (Phase 1) | Dec 1, 2024 | Amgen, University of Iowa |
| NCT04599062 | Phase 1/Phase 2 (Phase 2) | Sep 10, 2020 | Amgen, University of Iowa |
| NCT04330430 | Phase 2 | May 31, 2020 | Amgen, Netherlands Cancer Institute |
| NCT04427306 | Phase 2 | May 21, 2020 | Amgen, University of California, Davis |
| NCT04065152 | Phase 2 | Jan 1, 2020 | Assistance Publique - Hôpitaux de Paris |
| NCT04068181 | Phase 2 | Dec 24, 2019 | Amgen, Merck |
| NCT04163952 | Phase 1 | Dec 10, 2019 | National Cancer Institute (NCI), Rutgers University |
| NCT04185311 | Phase 1 | Jul 10, 2019 | National Cancer Institute (NCI), University of California, Los Angeles |
| NCT03972046 | Phase 2 | Jun 24, 2019 | TriHealth |
| NCT03886311 | Phase 2 | May 15, 2019 | Sarcoma Oncology Research Center, LLC |
| NCT03921073 | Phase 2 | Apr 15, 2019 | University of South Florida |
| NCT03842943 | Phase 2 | Mar 1, 2019 | University of Louisville |
| NCT03663712 | Phase 1 | Jan 1, 2019 | Duke University, University of Illinois at Chicago |
| NCT03554044 | Phase 1 | Dec 11, 2018 | Amgen, University of California, San Francisco |
| NCT03802604 | Early Phase 1 (Phase 1) | Dec 10, 2018 | Amgen, Roche, SOLTI Breast Cancer Research Group, University of Barcelona |
| NCT03597009 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2018 | Amgen, CareFusion, University of North Carolina at Chapel Hill |
| NCT03747744 | Phase 1 | Sep 28, 2018 | Free University of Brussels |
| NCT03714828 | Phase 2 | Aug 24, 2018 | Amgen, University of Arizona |
| NCT03555032 | Phase 1/Phase 2 (Phase 2) | Jun 26, 2018 | Royal Marsden Hospital NHS Trust |
Organizations
Research & Development (39)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Amgen | For profit | 32 | 13 | 4 | 2008 |
| BioVex | For profit | 6 | 6 | 3 | 2005 |
| National Cancer Institute (NCI) | Government | 6 | 4 | 2 | 2017 |
| Merck | For profit | 3 | 0 | 3 | 2014 |
| University of Iowa | Academic/Hospital | 3 | 3 | 2 | 2015 |
| Mary Crowley Cancer Center | Academic/Hospital | 2 | 0 | 2 | 2005 |
| Roche | For profit | 2 | 0 | 1 | 2018 |
| Royal Marsden Hospital NHS Trust | Academic/Hospital | 2 | 1 | 2 | 2011 |
| Rutgers University | Academic/Hospital | 2 | 1 | 2 | 2017 |
| University of California, San Francisco | Academic/Hospital | 2 | 2 | 1 | 2018 |
| University of South Florida | Academic/Hospital | 2 | 2 | 1 | 2017 |
| University of Texas at Houston | Academic/Hospital | 2 | 1 | 2 | 2016 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2020 |
| CareFusion | For profit | 1 | 0 | 1 | 2018 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Covance | For profit | 1 | 0 | 1 | 2008 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Free University of Brussels | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2026 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amgen | For profit | NDA | Oct 27, 2015 |