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Talimogene laherparepvec

Generic Name
Talimogene laherparepvec
Brand Names
Imlygic
Drug Type
Biotech
Chemical Formula
-
CAS Number
1187560-31-1
Unique Ingredient Identifier
07730V90L6
Background

Talimogene laherparepvec is an oncolytic treatment used in local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma. It is a genetically administered herpes simplex virus 1 (HSV-1) that expresses human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with antitumor and immune-stimulating activities. It specifically replicates within tumor cells and causes lysis. It was approved by the FDA in 2015 under the market name Imlygic.

In general, talimogene laherparepvec has been modified so that it can infect and multiply inside melanoma cells . The drug subsequently uses the melanoma cells' own machinery to multiply, eventually overwhelming the melanoma cells and killing them . Alternatively, although talimogene laherparepvec also enters healthy cells, it is not designed to multiply inside them .

Indication

This medication is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable, cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery . Elsewhere, the EMA notes that the agent is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral diseases .

Associated Conditions
Unresectable Skin Lesion
Associated Therapies
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nature.com
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Neoadjuvant oncolytic virus orienx010 and toripalimab in resectable acral melanoma: a phase Ib trial

Neoadjuvant ori+tori therapy in resectable stage III and IVM1a acral melanoma (AM) showed 77.8% pathological response, 85.2% 1-year RFS, and 81.5% 2-year RFS, surpassing previous adjuvant therapy alone. Limited data exist on adjuvant or neoadjuvant settings for AM, with most from retrospective studies showing RFS from 14.8 to 26 months. The NADINA study demonstrated neoadjuvant ipilimumab and nivolumab improved EFS over adjuvant nivolumab. AM is less responsive to immunotherapy; anti-PD-1 monotherapy ORR was 18.0% with median PFS of 3–5 months. Combination therapy of anti-PD-1 with oncolytic virus showed 77.8% pathological response, suggesting potential in advanced AM. Oncolytic virus modifies tumor microenvironment, enhancing immune cell activity and sensitivity to immunotherapy. Pathologic response is critical for neoadjuvant therapy efficacy; neoadjuvant ori+tori offered significant advantages over oncolytic virus monotherapy. Safety profiles were favorable, with 13.3% grade 3 AEs. PET/CT showed no correlation with pathological response, necessitating new evaluation technologies. These preliminary data encourage further controlled trials, especially in unresectable metastatic AM.
openpr.com
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Oncolytic Virus Therapy Clinical Trials FDA Approval Market Size Forecast

Oncolytic virus immunotherapy, a groundbreaking cancer treatment, targets cancer cells while sparing healthy ones, offering a safer and effective alternative to conventional therapies. Advances like Oncorine, Imlygic, and Delytact highlight its potential, promising a tailored, multifaceted approach to cancer treatment.

The next generation of herpes simplex virus-based oncolytic immunotherapy

The article reviews the evolution of oncolytic immunotherapy (OI) since the FDA approved talimogene laherparepvec for melanoma in 2015. It discusses the development of next-generation herpes simplex virus-based OIs, focusing on genetic modifications for safety, tumor-selective replication, and immune stimulation. The review also covers clinical evidence supporting OIs in overcoming resistance to immune checkpoint blockade and explores combination therapies to enhance OI efficacy.

Related Clinical Trials:

Advances in the clinical development of oncolytic viruses

Oncolytic viruses (OVs) selectively infect and kill cancer cells, showing significant anti-tumor effects with mild adverse events. As of October 2021, 408 clinical trials on 31 OV products have been conducted, with phase I and II studies making up 80%. OVs like H101, T-VEC, and G47Δ have been approved, demonstrating safety and efficacy in tumor treatment. Challenges include targeting, vector cell selection, and viral diffusion. OVs combined with other therapies enhance anti-tumor effects, indicating a promising future in cancer immunotherapy.
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