Talimogene Laherparepvec

Summary

Talimogene Laherparepvec (CHEMBL2108727) is an approved gene (ATC L01XL02); indicated across 12 conditions including melanoma and cutaneous melanoma.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Gene
• ATC class: L01XL02
• Indications: 12 conditions
• Clinical trials: 40

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108727
Name	Talimogene Laherparepvec
Type	Gene
Max phase	4
ATC	L01XL02

Also known as: Imlygic, Oncovex, Oncovex-ae, Oncovexgm-csf, Talimogen laherparepvec, Talimogene laherparepvec, Talmimogene laherparepvec, TALIMOGENE LAHERPAREPVEC

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

12 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
melanoma	4	MONDO:0005105	EFO:0000756
cutaneous melanoma	4	MONDO:0005012	EFO:0000389
soft tissue sarcoma	2	MONDO:0018078	EFO:1001968
Kaposi’s sarcoma	2	MONDO:0005055	EFO:0000558
sarcoma	2	MONDO:0005089	MONDO:0017387
breast carcinoma	1	MONDO:0004989	EFO:0000305
exocrine pancreatic carcinoma	1	MONDO:0005192	EFO:0002618
central nervous system cancer	1	MONDO:0002714	EFO:0000326
breast neoplasm	1	MONDO:0021100	MONDO:0007254
ductal breast carcinoma in situ	1	MONDO:0005023	EFO:0000432

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 40.

Phase distribution

Phase	Trials
PHASE2	14
PHASE1	14
PHASE1/PHASE2	5
PHASE3	4
Not specified	2
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00769704	PHASE3	COMPLETED	Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
NCT01161498	PHASE3	TERMINATED	Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer
NCT01368276	PHASE3	COMPLETED	An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
NCT02263508	PHASE3	TERMINATED	Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
NCT02923778	PHASE2	ACTIVE_NOT_RECRUITING	Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery
NCT02965716	PHASE2	ACTIVE_NOT_RECRUITING	Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
NCT02978625	PHASE2	ACTIVE_NOT_RECRUITING	Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
NCT03842943	PHASE2	RECRUITING	Neoadjuvant Combination Immunotherapy for Stage III Melanoma
NCT03886311	PHASE2	RECRUITING	Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma
NCT04599062	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	TVEC and Preop Radiation for Sarcoma (8 ml Dose)
NCT06660810	PHASE2	ACTIVE_NOT_RECRUITING	Neoadjuvant Intralesional Injection of Talimogene Laherparepvec
NCT00289016	PHASE2	COMPLETED	A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma
NCT01740297	PHASE1/PHASE2	COMPLETED	Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma
NCT02014441	PHASE2	COMPLETED	Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec
NCT02211131	PHASE2	COMPLETED	Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
NCT02366195	PHASE2	COMPLETED	Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
NCT02453191	PHASE1/PHASE2	COMPLETED	TVEC and Preop Radiation for Sarcoma (4 ml Dose)
NCT02509507	PHASE1/PHASE2	COMPLETED	Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
NCT02574260	PHASE2	COMPLETED	An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
NCT02658812	PHASE2	TERMINATED	Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery
NCT02779855	PHASE1/PHASE2	COMPLETED	Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
NCT04065152	PHASE2	UNKNOWN	Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma
NCT04068181	PHASE2	COMPLETED	Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
NCT07102394	PHASE1	RECRUITING	Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1
NCT00402025	PHASE1	COMPLETED	Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer
NCT02626000	PHASE1	COMPLETED	Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137)
NCT02756845	PHASE1	COMPLETED	Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
NCT03064763	PHASE1	COMPLETED	Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
NCT03086642	PHASE1	COMPLETED	Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer
NCT03088176	PHASE1	UNKNOWN	Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma
NCT03256344	PHASE1	COMPLETED	Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
NCT03300544	PHASE1	TERMINATED	Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer
NCT03430687	PHASE1	WITHDRAWN	Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma
NCT03554044	PHASE1	COMPLETED	T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer
NCT03663712	PHASE1	COMPLETED	Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies
NCT04163952	PHASE1	TERMINATED	Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin
NCT04185311	PHASE1	TERMINATED	Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted
NCT03802604	EARLY_PHASE1	COMPLETED	Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer
NCT02147951	Not specified	NO_LONGER_AVAILABLE	Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma
NCT02297529	Not specified	NO_LONGER_AVAILABLE	Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).