Product Description
Talimogene laherparepvec (T-VEC; IMLYGIC®, Amgen Inc.) is the first oncolytic viral immunotherapy to be approved for the local treatment of unresectable metastatic stage IIIB/C–IVM1a melanoma. Its direct intratumoral injection aim to trigger local and systemic immunologic responses leading to tumor cell lysis, followed by release of tumor-derived antigens and subsequent activation of tumor-specific effector T-cells. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8003308/)
Mechanisms of Action: GM-CSF Inhibitor
Novel Mechanism: No
Modality: Gene Therapy
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Greece | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: Western America
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 12
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Basal Cell Carcinoma|Carcinoma, Merkel Cell|Ductal Breast Carcinoma|Ductal Carcinoma|Hemangiosarcoma|Hepatocellular Carcinoma|Melanoma|Sarcoma|Sarcoma, Kaposi|Triple Negative Breast Cancer
Phase 1: Breast Cancer|Neurofibromatoses|Neurofibromatosis 1
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07102394 |
IRB00482551 | P1 |
Not yet recruiting |
Neurofibromatoses|Neurofibromatosis 1 |
2026-12-01 |
12% |
2025-09-06 |
Primary Endpoints|Treatments |
NCT03554044 |
NCI-2018-00652 | P1 |
Completed |
Breast Cancer |
2023-12-31 |
50% |
2025-05-22 |
|
2014-005386-67 |
MASTERKEY-318 | P2 |
Active, not recruiting |
Hepatocellular Carcinoma |
2026-09-27 |
35% |
2022-03-13 |
Treatments |
NCT03069378 |
NCT03069378 | P2 |
Active, not recruiting |
Hemangiosarcoma |
2025-07-22 |
12% |
2025-07-26 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT06660810 |
NCT06660810 | P2 |
Active, not recruiting |
Sarcoma |
2025-06-20 |
12% |
2025-10-11 |
Primary Endpoints |
NCT02819843 |
NCT02819843 | P2 |
Completed |
Carcinoma, Merkel Cell|Melanoma |
2024-02-22 |
58% |
2024-04-12 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-004403-12 |
2019-004403-12 | P2 |
Completed |
Sarcoma, Kaposi |
2023-07-21 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2018-002165-19 |
2018-002165-19 | P2 |
Active, not recruiting |
Basal Cell Carcinoma |
2022-05-10 |
2022-03-13 |
Treatments |
|
NCT02779855 |
MCC-18621 | P2 |
Active, not recruiting |
Ductal Carcinoma|Triple Negative Breast Cancer|Ductal Breast Carcinoma |
2020-09-20 |
12% |
2023-09-29 |
Primary Endpoints|Study Completion Date|Treatments |
2018-002677-22 |
T-VEC â US Doppler | P2 |
Active, not recruiting |
Melanoma |
2025-01-29 |
2022-03-13 |
||
2019-001906-61 |
2019-001906-61 | P2 |
Completed |
Melanoma |
2024-02-26 |
47% |
2025-07-06 |
Treatments |
NCT04599062 |
8 ml Dose | P2 |
Active, not recruiting |
Sarcoma |
2023-02-07 |
12% |
2023-06-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
07/11/2024 |
News Article |
Global Oncolytic Immunotherapy Clinical Trials Market Forecast Companies FDA approval Insight |
|
05/14/2024 |
News Article |
Oncolytic Virus Therapy Market Size Clinical Trials Sales Forecast 2030 |
|
09/29/2023 |
News Article |
Cell and Gene Therapy Market Size, Share, Growth 2023-2031 |
|
09/22/2023 |
News Article |
Revolutionary Cancer Treatment Advances Promise Brighter Future Amid Federal Funding Uncertainty |