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Talimogene laherparepvec (T-VEC, Imlygic) was the first approved oncolytic virus (2015), injected into melanoma skin lesions.
Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1 with ICP34.5 and ICP47 deleted, so it replicates in tumour cells but not healthy ones, and it expresses GM-CSF to attract antigen-presenting cells. It was the first approved oncolytic virus (2015), injected into unresectable melanoma lesions at 10^6 PFU/mL initially, then 10^8 PFU/mL 3 weeks later and every 2 weeks. In OPTiM the durable response rate was 16% versus 2% for GM-CSF alone. Uptake has been modest because responses concentrate in injected lesions, and the MASTERKEY-265 combination with pembrolizumab did not improve progression-free or overall survival. Amgen markets it; its legacy is proving the principle that later viruses build on. For a newcomer: the first cancer-killing virus approved, useful mainly for accessible skin lesions.
HSV-1 with ICP34.5 and ICP47 deleted, expressing GM-CSF.
1.HSV-1 with ICP34.5 and ICP47 deleted is injected into melanoma lesions
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intralesional injection by the clinician; HCPCS J9325.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA410 · SMC advice: talimogene laherparepvec. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US source
EMA approval source
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Unresectable melanoma with injectable lesions |
| Adverse event |
|---|
| Fatigue |
| Chills |
| Pyrexia |
| Nausea |
| Influenza-like illness |
| Injection-site pain |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | - |
| United Kingdom | NICE: recommended for unresectable melanoma when systemic immunotherapy is unsuitable (TA410) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The honest summary of the field after its first approval: a tolerable class of agents, a large number of candidates, and one product in routine use in one disease. The distinction the review keeps making, between viruses that replicate in the tumour and viruses used only to deliver a gene, is the distinction most coverage of this field drops.
This is the approval that created the class, and it is also the clearest example of how the class is oversold. A durable response rate eight times the comparator is a real local effect on injectable lesions. The survival comparison did not reach significance, and the comparator was granulocyte-macrophage colony-stimulating factor rather than a checkpoint inhibitor, which by 2015 was already the standard. A reader told that a virus improves survival in melanoma is being told something this trial did not show.
Query for this drug: (TITLE:"Talimogene laherparepvec" OR ABSTRACT:"Talimogene laherparepvec" OR TITLE:"Imlygic" OR ABSTRACT:"Imlygic" OR TITLE:"T-VEC" OR ABSTRACT:"T-VEC") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Talimogene laherparepvec, not a curated reading list.
Shares Oncolytic virus + PD-1 blockade, Kevin Harrington, Oncolytic viruses that make interleukin-12 only inside the tumour, Cold tumours: immune deserts and exclusion.
Shares Daromun, Stage III melanoma (after surgery), Melanoma.
Shares Oncolytic virus + PD-1 blockade, OPTiM: the trial that made talimogene laherparepvec the first approved oncolytic virus.
Shares Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma, GM-CSF receptor (CSF2RA).
Shares Stage III melanoma (after surgery), Advanced melanoma (unresectable stage III and stage IV), Melanoma.
Shares Amgen, Advanced melanoma (unresectable stage III and stage IV), Melanoma.
Shares Reinhard Dummer, Advanced melanoma (unresectable stage III and stage IV), Melanoma.