ICP34.5-, ICP47-DELETED HERPES SIMPLEX VIRUS 1 (HSV-1) INCORPORATING THE HUMAN GM-CSF GENE
Melanoma
Explore 435 assets in Melanoma →Floatz Rating
B62/100
Confidence
Indicative
Sponsor
Amgen
Modality
gene_therapy
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
61High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT04068181CT.gov Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). | — | Completed | — | — | — |
NCT03972046CT.gov Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma | — | Withdrawn | — | — | — |
NCT02965716CT.gov Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma | — | Active Not Recruiting | — | — | — |
NCT03088176CT.gov Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma | — | Unknown | — | — | — |
NCT03064763CT.gov Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma | — | Completed | — | — | — |
NCT02819843CT.gov A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors | — | Completed | — | — | — |
NCT02211131CT.gov Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma | — | Completed | — | — | — |
NCT02263508CT.gov Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma | — | Terminated | — | — | — |
NCT02014441CT.gov Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec | — | Completed | — | — | — |
NCT01740297CT.gov Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma | — | Completed | — | — | — |
Show 4 more trialsShow fewer
NCT01368276CT.gov An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma | — | Completed | — | — | — |
NCT00769704CT.gov Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma | — | Completed | — | — | — |
NCT02574260CT.gov An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016) | — | Completed | — | — | — |
NCT00289016CT.gov A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Melanoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| ICP34.5-, ICP47-DELETED HERPES SIMPLEX VIRUS 1 (HSV-1) INCORPORATING THE HUMAN GM-CSF GENE (this asset) | Amgen | P3 | B · 62 |
| Gm-Csf | Ultimovacs ASA | P4 | BBB |
| Sargramostim | Mayo Clinic | P3 | BBB |
| Cediranib | M.D. Anderson Cancer Center | P3 | BBB |
| Ifa | Craig L Slingluff, Jr | P2 | BB |
| Cyclophosphamide | Primmune Therapeutics, Inc. | P4 | BB |
| Temsirolimus | University of Regensburg | P2 | BB |
| Tebentafusp | Immunocore Ltd | P3 | BB |
| Dacarbazine | Suzhou BlueHorse Therapeutics Co., Ltd. | P3 | BB |
+42 more in the Melanoma cohort
Other indications for ICP34.5-, ICP47-DELETED HERPES SIMPLEX VIRUS 1 (HSV-1) INCORPORATING THE HUMAN GM-CSF GENE
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Cutaneous Neuroendocrine Carcinoma | — | P2 | B · 59 |
| Breast Carcinoma | — | P2 | B · 58 |
| Cutaneous Melanoma | — | P3 | B · 58 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. ICP34.5-, ICP47-DELETED HERPES SIMPLEX VIRUS 1 (HSV-1) INCORPORATING THE HUMAN GM-CSF GENE in Melanoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/icp345-icp47-deleted-herpes-simplex-virus-1-hsv-1-incorporating-the-human-gm-csf-gene-melanoma
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