Imlygic (talimogene laherparepvec) / Amgen - LARVOL DELTA

Recurrent melanoma presenting as a rash: a case report. (PubMed, Skin Health Dis) - "Here, we describe a case of a woman with stage IIIC melanoma undergoing intralesional talimogene laherparepvec (T-VEC) therapy who developed a spreading erythematous rash on her left leg, accompanied by fatigue and leg swelling. Skin biopsy revealed recurrent melanoma, with SOX10 and Melan-A positivity, and imaging showed features concerning for multifocal disease recurrence in the left popliteal fossa. This case highlights an unusual presentation of melanoma recurrence and underscores the importance of biopsy in -evaluating new skin findings in patients with a history of melanoma."

Journal • Fatigue • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • MLANA • SOX10

Recombinant Oncolytic Viruses: Hexagonal Warriors in the Field of Solid Tumor Immunotherapy. (PubMed, Curr Issues Mol Biol) - "Compared with T-VEC, the classical therapeutic agent that only expresses GM-CSF, which was approved in 2015, most new oncolytic virus designs include diverse gene constructs to reduce toxic effects, enhance multiple antitumor immunity, avoid immune clearance, or enhance tumor targeting...Finally, we explored the feasibility of the intravenous application of oncolytic viruses and their future development directions. We believe that the diversified treatment design of oncolytic viruses will bring more surprises to the immunotherapy of refractory tumors."

Journal • Review • Herpes Simplex • Oncology • Solid Tumor • CSF2

OUTCOMES OF TALIMOGENE LAHERPAREPVEC IN SOFT TISSUE SARCOMA (CTOS 2025) - "This case series of patients receiving TVEC for sarcoma adds to the literature of intralesional therapies for this rare disease. Our experience suggests that TVEC may be administered safely and may provide local tumor control in select patients who have failed prior therapy with ICI."

Alveolar Soft Tissue Sarcoma • Angiosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Phase Ib study of intratumoral talimogene laherparepvec (T-VEC) in combination with chemotherapy or endocrine therapy in patients with advanced HER2-negative breast cancer. (PubMed, NPJ Breast Cancer) - P1 | "Intratumoral T-VEC was administered with the following partners: gemcitabine/carboplatin (n = 8), nab-paclitaxel (n = 7), paclitaxel (n = 2), or ET (n = 2). In conclusion, the addition of intratumoral T-VEC to CT or ET was safe in patients with ABC and injectable locoregional disease, supporting the continued investigation of direct intratumoral immunomodulatory strategies that can enhance local and systemic immune responses. NCT03554044."

Journal • P1 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

S1607: Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Tumor mutational burden • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Lower Risk Invasive Cutaneous Squamous Cell Cancer. (PubMed, J Am Acad Dermatol) - "Intralesional TVEC demonstrated promising efficacy and tolerability as a minimally invasive treatment for low to intermediate risk cSCC with potential to reduce subsequent incidence rates."

Journal • P2 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection (clinicaltrials.gov) - P=N/A | N=187 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=300 ➔ 187 | Trial completion date: Jan 2038 ➔ Jan 2026 | Trial primary completion date: Jan 2038 ➔ Jan 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Melanoma • Oncology • Solid Tumor

Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1 (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Johns Hopkins University | Initiation date: Nov 2025 ➔ Feb 2026

Trial initiation date • Genetic Disorders • Neurofibromatosis • Solid Tumor

Economic Evaluation of Neoadjuvant Talimogene Laherparepvec Plus Surgery for Resectable Stage IIIB-IV M1a Melanoma (ISPOR-EU 2025) - "Neoadjuvant T-VEC plus surgery is a cost-effective strategy compared to surgery alone for patients with resectable stage IIIB-IVM1a melanoma from the US third-party payer's perspective."

Clinical • HEOR • Surgery • Melanoma • Solid Tumor

Opportunities and challenges in the clinical application of anticancer virotherapy. (PubMed, Expert Rev Anticancer Ther) - "In 2015, Talimogene laherparepvec (T-VEC) was approved OV for melanoma...The ability to use OVs to add to defined mechanisms of anti-tumor activity, such as direct tumor cell killing, induction of anti-viral and anti-tumor immune responses, and effective delivery of therapeutic payloads, have resulted in multiple new OVs with promising early clinical data. OVs can be an especially useful tool for developing a more personalized approach to cancer treatment based on unique clinical features of patients and the molecular features of specific tumors."

IO biomarker • Journal • Review • Melanoma • Oncology • Solid Tumor

Response analysis for injected and non-injected lesions and of the safety and efficacy of superficial and deep/visceral RP1 injection in the registrational cohort of anti–PD-1–failed melanoma patients of the IGNYTE trial (JADPRO 2025) - "Prior anti-PD-1 therapy was nivolumab (53.6%), pembrolizumab (46.4%), or both (0%). Prior CTLA-4 inhibitor: 6.4% Prior BRAF/MEK inhibitor: 16.0% Prior chemotherapy: 32.0% Prior IL-2: 11.2% Prior T-VEC: 1.6% Prior other anti-cancer agents: 3.2% Sixty-one (48.8%) patients had prior anti-PD-1 monotherapy alone for advanced disease, 45.6% had anti-PD-1 + other agents, and 5.6% had received both therapies sequentially...Clinical activity of RP1 monotherapy was observed after deep/visceral injections or superficial injections only. Responses can be achieved by RP1 monotherapy and were reproducible in non-injected lesions."

Clinical • Cutaneous Melanoma • Eye Cancer • Hepatology • Melanoma • Mucosal Melanoma • Solid Tumor • Uveal Melanoma • IL2

Talimogene Laherparepvec treatment for mucosal melanoma with metastatic lymph node metastasis: case report. (PubMed, Front Oncol) - "It supports findings from case reports demonstrating good response to T-VEC in mucosal melanomas of the urethra, maxillary sinus, and the soft and hard palate. Prospective studies assessing the efficacy of T-VEC in treating mucosal melanoma are needed to confirm these findings."

Journal • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

The Evolution, Current Landscape, and Future Prospects of Oncolytic Virotherapy in Melanoma: Talimogene Laherparepvec and Beyond. (PubMed, Cells) - "We begin by describing early investigations using wild type viruses and then the development of sophisticated Herpes simplex virus 1 (HSV-1) variant constructs such as talimogene laherparepvec (T-VEC) and vusolimogene oderparepvec (Replimune-1, RP1), which incorporate deletions of viral genes and expression of human or synthetic transgenes to promote tumor selectivity, dendritic cell recruitment, antigen presentation, and stimulation of systemic anti-tumor immune responses. We review the status of clinical trials of oncolytic viruses in melanoma, highlight regulatory challenges, and describe important concepts and key remaining questions within the field. While T-VEC remains the only Food and Drug Administration (FDA)-approved oncolytic virus for melanoma treatment, ongoing research focusing on next-generation viral constructs and combination strategies aims to further improve clinical outcomes and expand the applicability of oncolytic virus therapy in melanoma."

IO biomarker • Journal • Review • Herpes Simplex • Melanoma • Oncology • Solid Tumor

Administration of Intralesional Oncolytic Virus Injections by Advanced Practice Providers (JADPRO 2025) - "T-VEC, the first FDA-approved OV therapy (a modified herpes simplex virus type-1 (HSV-1), is the first FDA-approved for the treatment of advanced melanoma. PVSRIPO (a modified poliovirus) and also a genetically modified HSV-1, is currently under investigation in a phase 3 clinical trial and early phase clinical trials, respectively, both showing promise, alone and in combination with nivolumab, in patients with advanced melanoma and other progression on prior anti-PD-1 therapy...If not currently in practice, cancer centers should expand the role of APPs to include administration of intralesional injections, which may help increase patient access to effective therapies Standardized training would support safe, effective implementation of OV therapies across cancer centers. Consider an institutional champion for OVs to help facilitate OV implementation and overcome institutional barriers."

Metastases • Oncolytic virus • Head and Neck Cancer • Herpes Simplex • Melanoma • Solid Tumor

Response and survival in in-transit metastatic unresectable melanoma according to treatment strategy (ESMO 2025) - "Results A total of 458 patients were included: 212 received first-line anti-PD1 (aPD1), 179 T-VEC, and 67 BRAF(/MEK) inhibition (BMi)...After adjusting for potential confounding factors PFS and OS were comparable across patients receiving aPD1, TVEC or BMi. Legal entity responsible for the study The authors."

Metastases • Melanoma • Oncology • Solid Tumor

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec (clinicaltrials.gov) - P2 | N=2 | Active, not recruiting | Sponsor: John Rieth | Recruiting ➔ Active, not recruiting | N=30 ➔ 2 | Trial completion date: Nov 2033 ➔ Mar 2030 | Trial primary completion date: Nov 2028 ➔ Jun 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Durable Response to Talimogene Laherparepvec (TVEC) Therapy in Advanced Melanoma: Regional Therapy As an Adjunct or Replacement for Surgical Resection? (ACS-CLINCON 2025) - "Our real-world experience with TVEC demonstrates it can often achieve durable disease control in the refractory setting. Clinical determination of complete response was comparable to pathologic confirmation in portending durable response.Early identification of patients who may be responders to TVEC can optimize patient selection. Durable responses to definitive intralesional therapy warrant further investigation as observation, rather than surgical resection, may be feasible and safe."

Metastases • Melanoma • Oncology • Solid Tumor

★ B Cell Depletion Augments Talimogene Laherparepvec (T-VEC) Reversal of Anti-PD1 Resistance (ACS-CLINCON 2025) - "Our findings highlight a significant therapeutic improvement with B cell depletion in combination with T-VEC in anti-PD-1 resistant melanoma. These results suggest a pivotal role for B cells in modulating the immune response, and ongoing studies are focused on uncovering the precise populations and mechanisms driving this enhanced efficacy and its potential to reshape long-term immunity."

IO biomarker • Melanoma • Oncology • Solid Tumor • GZMB

Addition of oncolytic virotherapy to clinical isolated limb perfusion for melanoma and sarcoma activates antitumor immunity. (PubMed, J Immunother Cancer) - "These clinical and translational findings support the further development of oncolytic virotherapy/ILP combinations to activate both systemic and local antitumor immunity, including in tumor types such as sarcoma, which are largely refractory to current treatment with immunotherapy."

IO biomarker • Journal • Herpes Simplex • Melanoma • Oncology • Sarcoma • Solid Tumor • TNFA

Opportunities, challenges, and future perspectives of oncolytic virus therapy for malignant melanoma. (PubMed, Front Immunol) - "Clinically, T-VEC combined with pembrolizumab achieves a 48.6% ORR with grade ≥3 AEs occurring in <20% of patients-superior to either monotherapy or conventional chemoradiotherapy. Integration of artificial intelligence with biomarkers-such as neutralizing antibody titers, ISG expression, and STING methylation-may further enable personalized OV-based therapies. This review discusses OV therapy's mechanisms, clinical impact, and future prospects in melanoma treatment."

IO biomarker • Journal • Review • Melanoma • Oncology • Solid Tumor • ITGAE

A New Era in Oncology: Clinical Insights Into the Application of Oncolytic Viruses. (PubMed, Cancer Control) - "Following the US Food and Drug Administration (FDA) approval of the HSV-based therapy (T-VEC) for Melanoma, interest in exploring other viral platforms for the potential treatment of various cancer types has notably expanded...For the scope of this review, clinical trial data spanning the past 11 years (2013 to 2024) were accessed from ClinicalTrials.gov and further categorized according to their ongoing clinical trial phases and their utilization in combination with Immune Checkpoint Inhibitors (ICI) or other established therapies. In summary, this work presents a comprehensive overview of recent developments within the field of cancer therapy, specifically concerning Oncolytic Viruses."

Journal • Review • Herpes Simplex • Infectious Disease • Measles • Melanoma • Oncology • Solid Tumor

PROMETEO: Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: SOLTI Breast Cancer Research Group | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Quantitative habitat concentration analysis of triple negative breast cancer on MRI correlates with pathologic response to combination neoadjuvant immuno/chemotherapy. (PubMed, Clin Imaging) - "Above-average concentration of functional tumor/high enhancement voxels within tumors before NAIC correlates with higher pCR rates and lower %TC at surgery."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Engineered oncolytic herpes simplex virus expressing interleukin 12 suppresses tumorigenicity of hepatocellular carcinoma. (PubMed, Biochim Biophys Acta Mol Basis Dis) - "Talimogene laherparepvec (T-VEC), a genetically modified oncolytic herpes simplex virus type 1 (HSV-1) engineered to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), has received United States Food and Drug Administration (FDA) approval for melanoma treatment...Notably, the oHSV-IL12 monotherapy showed comparable therapeutic outcomes to the combination of oHSV-GMCSF and oHSV-IL12 in both rechallenge and survival experiments. These findings position oHSV-IL12 as a promising novel candidate for HCC immunotherapy."

IO biomarker • Journal • Hepatocellular Cancer • Herpes Simplex • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • CSF2 • IFNG • IL12A

Anatomic Location Predicts Response Rates: Real World Outcomes with Over 1,100 Cycles of Talimogene Laherparepvec (TVEC) Description: A Retrospective Review of a Prospectively Maintained Database. (PubMed, Ann Surg) - "This is the largest prospective cohort evaluating real-world outcomes of metastatic melanoma patients treated with TVEC based on anatomic location. TVEC is a well-tolerated, durable treatment for advanced staged melanoma. Our findings demonstrate head/neck metastases have the greatest CR rate and should be considered as a possible first-line therapy in select patients."

Journal • Real-world evidence • Retrospective data • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor