Talimogene laherparepvec

Phase 3Gene therapy

Talimogene laherparepvec is one of 342 biologic programs targeting Central Nervous System Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

341

Competitors

Pipeline

Status by Indication[3][1]

Indication

Central Nervous System CancerActive, not recruiting

Bladder Transitional Cell CarcinomaActive, not recruiting

Cutaneous MelanomaActive, not recruiting

Skin CancerActive, not recruiting

Pleural EffusionActive, not recruiting

Kaposi's SarcomaActive, not recruiting

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

MelanomaUnknown

Pancreatic CancerActive, not recruiting

Central Nervous System CancerPhase 1

Active, not recruiting

Bladder Transitional Cell CarcinomaPhase 1

Active, not recruiting

Cutaneous MelanomaPhase 3

Active, not recruiting

Skin CancerPhase 2

Active, not recruiting

Pleural EffusionPhase 1/Phase 2

Active, not recruiting

Kaposi's SarcomaPhase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Colorectal CancerPhase 1

Active, not recruiting

MelanomaPreclinical

Unknown

Pancreatic CancerPhase 1

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Talimogene laherparepvec

Amgen

Phase 3

5 2

Halaven

Eisai

Preclinical

38 3

Trodelvy

Gilead

Preclinical

37 4

Megace

Bristol-Myers Squibb

Preclinical

4 5

Spravato

WWim Janssens

Preclinical

2 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Aquasol E

NNational Eye Institute (NEI)

Systemic Therapy

1 9

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 10

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Melanoma

NCT02965716

Phase 2Active, not recruiting

Soft Tissue Sarcoma

NCT02923778

Q3 2027

Phase 2Active, not recruiting

Skin Cancer

NCT02978625

Q1 2028

Phase 1/2Active, not recruiting

Sarcoma

NCT04599062

Q2 2028

Phase 2Recruiting

Melanoma

NCT03842943

Clinical

Trials by Indication[1]

Melanoma14 trials

Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

Completed·BBioVex Limited·Phase 3·NCT00769704·437 enrolled

Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

Terminated· Amgen logo

Amgen·Phase 3·NCT02263508·713 enrolled

Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02965716·43 enrolled

Show 11 more trials

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Recruiting·UUniversity of Louisville·Phase 2·NCT03842943·28 enrolled

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Completed· Amgen logo

Amgen·Phase 2·NCT04068181·72 enrolled

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

No longer available· Amgen logo

Amgen··NCT02147951

Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma

Completed· Amgen logo

Amgen·Phase 1/2·NCT01740297·217 enrolled

An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma

Completed·BBioVex Limited·Phase 3·NCT01368276·31 enrolled

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Withdrawn·TTriHealth Inc.·Phase 2·NCT03972046

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

Completed·BBioVex Limited·Phase 2·NCT00289016·50 enrolled

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

Completed· Amgen logo

Amgen·Phase 2·NCT02211131·150 enrolled

Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

Completed· Amgen logo

Amgen·Phase 2·NCT02366195·112 enrolled

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

No longer available· Amgen logo

Amgen··NCT02297529

Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma

Completed· Amgen logo

Amgen·Phase 1·NCT03064763·18 enrolled

Breast Cancer5 trials

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT03554044·20 enrolled

Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT03802604·28 enrolled

Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT02779855·50 enrolled

Show 2 more trials

Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT04185311·6 enrolled

Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02658812·11 enrolled

Sarcoma2 trials

TVEC and Preop Radiation for Sarcoma (8 ml Dose)

Active, not recruiting·JJohn Rieth·Phase 1/2·NCT04599062·8 enrolled

TVEC and Preop Radiation for Sarcoma (4 ml Dose)

Completed·UUniversity of Iowa·Phase 1/2·NCT02453191·30 enrolled

Pancreatic Cancer2 trials

Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer

Completed·BBioVex Limited·Phase 1·NCT00402025·17 enrolled

Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer

Completed·—·Phase 1·NCT03086642·10 enrolled

Squamous Cell Carcinoma2 trials

Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137)

Completed· Amgen logo

Amgen·Phase 1·NCT02626000·36 enrolled

Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin

Terminated·RRutgers, The State University of New Jersey·Phase 1·NCT04163952·5 enrolled

17 more indications

Pembrolizumab1 trial

Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

Completed· Amgen logo

Amgen·Phase 1/2·NCT02509507·127 enrolled

Skin Cancer1 trial

Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02978625·68 enrolled

Locally Advanced Head and Neck Cancer1 trial

Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer

Terminated·BBioVex Limited·Phase 3·NCT01161498·5 enrolled

CNS Tumors1 trial

Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

Completed· Amgen logo

Amgen·Phase 1·NCT02756845·15 enrolled

Colorectal Cancer1 trial

Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases

Completed· Amgen logo

Amgen·Phase 1·NCT03256344·36 enrolled

Trial1 trial

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

Completed· Amgen logo

Amgen·Phase 2·NCT02014441·61 enrolled

Locally Advanced1 trial

A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03069378·41 enrolled

Tumour1 trial

TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion)

Completed·RRoyal Marsden NHS Foundation Trust·Phase 1/2·NCT03555032·15 enrolled

Pleural effusion1 trial

A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 1/2·NCT03597009·1 enrolled

Merkel Cell Carcinoma1 trial

A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02819843·19 enrolled

Soft Tissue Sarcoma1 trial

Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02923778·40 enrolled

Malignancies1 trial

Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies

Completed·—·Phase 1·NCT03663712·28 enrolled

Radiation Therapy1 trial

Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT03300544·3 enrolled

Kaposi Sarcoma1 trial

Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04065152·20 enrolled

Neoadjuvant1 trial

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

Active, not recruiting·JJohn Rieth·Phase 2·NCT06660810·2 enrolled

Bladder Transitional Cell Carcinoma1 trial

Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma

Withdrawn·UUniversity of California, San Francisco·Phase 1·NCT03430687

ART1 trial

An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)

Completed·BBioVex Limited·Phase 2·NCT02574260·3 enrolled

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Talimogene laherparepvec. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Talimogene laherparepvec compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Talimogene laherparepvec. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Gene therapy[2]
Highest Phase: Phase 3[1]
Company: Amgen

Talimogene laherparepvec

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Melanoma14 trials

Breast Cancer5 trials

Sarcoma2 trials

Pancreatic Cancer2 trials

Squamous Cell Carcinoma2 trials

Pembrolizumab1 trial

Skin Cancer1 trial

Locally Advanced Head and Neck Cancer1 trial

CNS Tumors1 trial

Colorectal Cancer1 trial

Trial1 trial

Locally Advanced1 trial

Tumour1 trial

Pleural effusion1 trial

Merkel Cell Carcinoma1 trial

Soft Tissue Sarcoma1 trial

Malignancies1 trial

Radiation Therapy1 trial

Kaposi Sarcoma1 trial

Neoadjuvant1 trial

Bladder Transitional Cell Carcinoma1 trial

ART1 trial

References

Drug Info

Quick Facts

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