Imlygic (talimogene laherparepvec) / Amgen - LARVOL DELTA

Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin for advanced leiomyosarcoma and liposaroma (NCT03886311). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT03886311 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • P2 data • Leiomyosarcoma • Oncology • Sarcoma • Solid Tumor

Long-term outcomes in triple-negative breast cancers (TNBC) treated with talimogene laherparepvec (TVEC) in combination with neoadjuvant chemotherapy (NACT). (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT02779855 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Biosafety of the novel oncolytic immunotherapy RP1: Considerations from a nursing perspective (ONS 2025) - P2 | "While some guidance does exist for talimogene laherparepvec, the first FDA–approved OI agent, understanding safety and care considerations for OIs will be essential to patient care as this field rapidly expands...RP1 combined with the immune checkpoint inhibitor nivolumab has demonstrated clinical activity and a favorable safety profile in clinical trials...Discussion RP1 administration showed negligible potential for viral transmission to caregivers, patients, or their families. As more patients may be treated with RP1 (and/or other OIs) in various settings (eg, academic and community health centers, clinical trials, commercial setting upon FDA approvals, etc.), understanding of these findings is essential for nurses to effectively communicate safety and care considerations to patients."

Clinical • Oncolytic virus • Oncology • Skin Cancer

In Situ Cancer Vaccines: Redefining Immune Activation in the Tumor Microenvironment. (PubMed, ACS Biomater Sci Eng) - "Currently approved in situ vaccines, such as T-VEC, have demonstrated clinical promise, while ongoing clinical trials continue to explore novel strategies for broader efficacy...However, significant barriers such as tumor heterogeneity, immune evasion, and logistical challenges remain. This review explores strategies for developing potent cancer vaccines, examines ongoing clinical trials, evaluates immune stimulation methods, and discusses prospects for advancing in situ cancer vaccination."

Biomarker • Journal • Review • Immune Modulation • Immunology • Infectious Disease • Oncology • CD8

Combination of Talimogene Laherparepvec (T-VEC) with Atezolizumab (atezo) in patients (pts) with residual breast cancer (BC) after standard neoadjuvant chemotherapy (NAC): Survival results of the SOLTI-PROMETEO study (ESMO-BC 2025) - No abstract available

Clinical • Breast Cancer • Oncology • Solid Tumor

Oncolytic viral therapy for nonmelanoma skin cancer and cutaneous lymphoma - A systematic review. (PubMed, JAAD Int) - "OVs used include Talimogene laherparepvec (73%, n = 8), measles virus (9%, n = 1), vesicular stomatitis virus (9%, n = 1), and adenovirus (9%, n = 1)...Overall, heterogeneity of existing studies significantly limits generalizability of results. Further research is needed to reveal the potential role of OVs in the future of nonmelanoma skin cancer and cutaneous lymphoma treatment."

Journal • Review • Basal Cell Carcinoma • Cutaneous T-cell Lymphoma • Genetic Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Measles • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • T Cell Non-Hodgkin Lymphoma

A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Angiosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Comparative real-world outcomes of stage III melanoma patients treated with talimogene laherparepvec or interleukin 2. (PubMed, Ther Adv Med Oncol) - "No significant differences in PFS, OS, or best response rates were observed between IL-2 and T-VEC treatments. The choice of therapy may be influenced by factors such as availability, physician preference, and patient-specific considerations."

Journal • Real-world evidence • Melanoma • Oncology • Solid Tumor • IL2

Phase Ib/II trial of talimogene laherparepvec alone and with pembrolizumab in advanced solid tumors with liver metastases and hepatocellular carcinoma. (PubMed, Oncologist) - P1/2 | "Limited efficacy across tumor types evaluated limit further evaluation of intrahepatic T-VEC+pembrolizumab in this patient population."

Journal • P1/2 data • Breast Cancer • Hepatocellular Cancer • Hepatology • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer

Single-cell analysis of oncolytic virotherapy in adult T-cell leukemia/lymphoma. (PubMed, J Immunother Cancer) - "Single-cell analysis revealed that T-VEC treatment induced robust local and systemic immune responses, including tumor necrosis, activation of M1 macrophages, and infiltration of CD8+ effector memory T cells. These findings demonstrate T-VEC's safety and efficacy in generating both localized oncolysis and systemic anti-tumor immune response, highlighting its promise as a novel therapeutic approach for refractory ATLL."

Journal • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD8

Diversity, Equity, and Inclusion in Gene and Cell Therapies Clinical Trials (ISPOR 2025) - "The lowest enrollment was for atidarsagene autotemcel (7 participants), while sipuleucel-T had the highest (512 participants)...White participants were disproportionately represented, particularly in sipuleucel-T (90.0%) and talimogene laherparepvec (97.9%). The findings revealed persistent racial disparities in gene and cell therapy clinical trials, with minority populations underrepresented and White participants comprising the majority. Achieving DEI in clinical trials remains a challenge, underscoring the need for greater efforts to address these disparities."

Clinical • Gene Therapies • Oncology

Cancer Vaccines: A Novel Revolutionized Approach to Cancer Therapy. (PubMed, Indian J Clin Biochem) - "In therapeutic vaccine only three are approved: Sipuleucel T-cell vaccine for treatment refractory prostatic cancer, BCG vaccine for early bladder cancer and T-VEC for inoperable melanoma. Heterogeneity within and between cancer types, screening and identifying suitable antigen specific to tumors and selection of vaccine delivery platforms are challenges in the development of vaccines. Adoptive cell therapy, Chimeric antigen receptor T cell therapy are recent breakthrough for cancer treatment."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Infectious Disease • Melanoma • Oncology • Prostate Cancer • Solid Tumor

Oncolytic Virus Therapy in a New Era of Immunotherapy, Enhanced by Combination with Existing Anticancer Therapies: Turn up the Heat! (PubMed, J Cancer) - "Combining oncolytic viruses with immune checkpoint inhibitors provides a significant increase in efficacy when viral therapy was combined with the drug ipilimumab...This review aims to identify and evaluate the potential of currently evolving oncolytic viral therapy with recent advances in genetic engineering providing enhanced oncolytic activity in the tumour, and addressing the lack of host immune responses in 'cold' tumours, with an additional role in enhancing conventional treatment efficacy with combination therapies. The potential of oncolytic viruses to 'turn up the heat' of a tumour microenvironment immunogenicity in combination with other anticancer treatments, provides a promising future for new cancer therapies."

Journal • Review • Oncology

Two-day scheduled break between lymphodepleting chemotherapy and tumor infiltrating lymphocyte therapy infusion: a single institution experience (EADO-WCM 2025) - "Background Lifileucel is a tumor infiltrating lymphocyte therapy (TIL) approved in February 2024 in the United States for the treatment of refractory melanoma. TIL was approved to be administered as soon as possible after 24 hours, but no later than four days after the last dose of fludarabine given as part of lymphodepleting chemotherapy (LDC)...One patient received talimogene laherparepvec as bridging therapy...Conclusions In a single institution experience, a two-day break between LDC and TIL infusion resulted in expected efficacy and no unexpected toxicity in patients with refractory melanoma. Signs of transient rise in lymphocyte count independent of bone marrow recovery may suggest better cell expansion, however further studies are needed to define the potential risks and benefits of delayed TIL infusion after LDC."

Clinical • IO biomarker • Tumor-infiltrating lymphocyte • Hematological Disorders • Melanoma • Oncology • Solid Tumor

HSV-1 as a gene delivery platform for cancer gene therapy. (PubMed, Trends Pharmacol Sci) - "Clinically approved oncolytic HSV-1 (oHSV-1) variants, such as T-VEC and G47Δ, demonstrate safety and efficacy in localized tumors, but face challenges in treating metastatic disease. To address this issue, next-generation oHSV-1 designs focus on precision targeting and immune remodeling through the delivery of multiple exogenous genes. In this review, we provide an overview of the inherent characteristics of oHSV-1 as a gene delivery platform, focusing on its genetic modification strategies, safety challenges in clinical applications, and future directions to maximize its therapeutic potential."

Journal • Review • Gene Therapies • Herpes Simplex • Oncology

NIVEC: Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: The Netherlands Cancer Institute | Active, not recruiting ➔ Completed

Trial completion • Melanoma • Oncology • Solid Tumor

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: John Rieth | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Advancements in Melanoma Treatment: A Review of PD-1 Inhibitors, T-VEC, mRNA Vaccines, and Tumor-Infiltrating Lymphocyte Therapy in an Evolving Landscape of Immunotherapy. (PubMed, J Clin Med) - "PD-1/PD-L1 inhibitors such as pembrolizumab and nivolumab block immune checkpoints, promoting T-cell cytotoxic activity and improving overall survival in patients with advanced melanoma...mRNA vaccines, such as Moderna's mRNA-4157/V940, take advantage of malignant-cell-specific neoantigens to amplify the adaptive immune response while protecting healthy tissue...This review explores combination therapies such as PD-L1 inhibitors with mRNA vaccines, or TIL therapy, which aim to enhance treatment through synergistic approaches. Further research is required to optimize these combinations, address barriers preventing their use, and control adverse events."

Journal • Review • Tumor-infiltrating lymphocyte • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor

Melanoma neoadjuvant treatment: review and update of recent trials. (PubMed, Expert Rev Anticancer Ther) - "The variety of regimens and dosing schedules investigated highlights the need for further research to determine the most appropriate treatments in this clinical setting. Advances in the study of biomarkers that can identify specific subgroups of patients will guide future research in this field."

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

Clinical Improvement of Treatment-Resistant Metastatic Basal Cell Carcinoma After Intratumoral Injection of Talimogene Laherparepvec. (PubMed, Dermatol Surg) - No abstract available

Journal • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

SOC-1882: Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Sarcoma Oncology Research Center, LLC | N=40 ➔ 200 | Trial completion date: Mar 2025 ➔ Jul 2031 | Trial primary completion date: Dec 2024 ➔ Dec 2030

Enrollment change • Trial completion date • Trial primary completion date • Chordoma • Desmoid Tumors • Oncology • Sarcoma • Solid Tumor

Orphan Drug Designations and Approvals (FDA) - Generic Name: talimogene laherparepvec, Trade Name: IMLYGIC, Date Designated: 03/14/2011, Orphan Designation: Treatment of stage IIb-stage IV melanoma, Orphan Designation Status: Designated/Approved

Orphan drug • Melanoma

Editorial: Oncolytic virotherapy, volume II. (PubMed, Front Mol Biosci) - No abstract available

Journal

Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=50 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2024 ➔ Mar 2025

Trial completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

TVEC and Preop Radiation for Sarcoma (8 ml Dose) (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: John Rieth | Trial completion date: Nov 2024 ➔ Nov 2027

Trial completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor