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Drug

Talimogene laherparepvec

Approved · EMA
Emerging researchLate-stage development

Also known as Imlygic, T Vec, T-Vec.

RxNorm1721264UNII07730V90L6
1
Research papers
7
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue Sarcoma

Clinical trial2026-06-17Results expected Q4 2026 · ClinicalTrials.gov

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

Clinical trial2026-05-26Primary completion · ClinicalTrials.gov

A Phase II Study of Combining Talimogene Laherparepvec (T-VEC) (NSC-785349) and MK-3475 (Pembrolizumab) (NSC-776864) in Patients With Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy

Clinical trial2026-05-20Results posted · ClinicalTrials.gov

A Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors

Clinical trial2026-05-13Results expected Q3 2027 · ClinicalTrials.gov

A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Clinical trial2026-03-10Results posted · ClinicalTrials.gov

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

Clinical trial2026-01-29Results posted · ClinicalTrials.gov

A Phase II Study of Talimogene Laherparepvec (T-VEC) Administered Concurrently With the Anti-PD1 Monoclonal Antibody Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Clinical trial2025-10-29Results posted · ClinicalTrials.gov

A Phase 1 Study of Talimogene Laherparepvec and Panitumumab in Patients With Locally Advanced Squamous Cell Carcinoma of the Skin (SCCS)

Clinical trial2025-03-28Terminated · ClinicalTrials.gov

Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)

Clinical trial2025-03-18Completed · ClinicalTrials.gov

Approval: Imlygic (EMA)

Regulatory2015-12-16EMA

Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma.

Research2015-05-26Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Talimogene laherparepvec
Aliases & brands
ImlygicT VecT-Vec
RxNorm CUI
1721264
UNII
07730V90L6
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-12-16
Latest approval
2015-12-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2015-12-16Approval
Approval: Imlygic (EMA)
Indication: Imlygic 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… Show full indication

Imlygic 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 disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

43 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
43
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
1
Recruiting
4
Late-stage (III+)
24
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 43
Early Phase 11Phase 112Phase 1 / 27Phase 219Phase 34

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

TerminatedPH IIIAmgenn=7132021

A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

CompletedPH IIIBioVex Limitedn=4372014

An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment With OncoVEX^GM-CSF for Eligible Melanoma Patients Participating in Study 005/05

CompletedPH IIIBioVex Limitedn=312014

A Phase 3 Randomized Trial of Concurrent Cisplatin & Radiotherapy With Or Without ONCOVEX^GM-CSF In Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

TerminatedPH IIIBioVex Limitedn=52011

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

CompletedPH I/IIH. Lee Moffitt Cancer Center and Research Instituten=502025

Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)

CompletedPH ISOLTI Breast Cancer Research Groupn=282025

Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease

CompletedPH IIThe Netherlands Cancer Instituten=242025

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

CompletedPH IIAmgenn=722024

A Phase II Randomized Trial of Intralesional Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) With or Without Radiotherapy for Cutaneous Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

CompletedPH IIMemorial Sloan Kettering Cancer Centern=192024

A Phase 1b Study of Talimogene Laherparepvec (T-VEC) in Combination With Chemotherapy or Endocrine Therapy in Patients With Metastatic, Unresectable, or Locoregionally Recurrent HER2-negative Breast Cancer

CompletedPH IUniversity of California, San Franciscon=202023

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015 · 1,892 cites
Recent papers

Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015 · 1,892 cites
Major research themes3
Herpesvirus 1, Human1Oncolytic Virotherapy1Oncolytic Viruses1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Agarwala SS1
  • Amatruda T1
  • Andtbacka RH1
  • Chesney J1
  • Coffin RS1
  • Collichio F1
  • Cranmer L1
  • Curti B1
Leading institutions
free-text, unnormalised
  • Huntsman Cancer Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.