Talimogene laherparepvec
- Generic Name
- Talimogene laherparepvec
- Brand Names
- Imlygic
- Drug Type
- Biotech
- 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
Cancer Vaccines Emerge as Promising Frontier in Oncology with Multiple Approaches Showing Clinical Success
• Cancer vaccines are gaining momentum across multiple tumor types, with FDA-approved options like BCG, sipuleucel-T, and talimogene laherparepvec demonstrating clinical utility in bladder cancer, prostate cancer, and melanoma respectively.
• Novel vaccine approaches including mRNA-based mRNA-4157, KRAS-targeted ELI-002, and viral vector-based aglatimagene besadenovec are showing promising results in clinical trials, with significant improvements in survival outcomes across various cancers.
• Experts believe cancer vaccines hold particular promise in early-stage and high-risk disease settings by targeting micrometastatic disease, potentially increasing cure rates and transforming treatment paradigms when combined with existing immunotherapies.
Japan Approves Groundbreaking Viral Therapy Teserpaturev for Glioblastoma Treatment
• Japan's health ministry committee has approved Teserpaturev, the country's first virotherapy drug developed by Daiichi Sankyo, marking a significant breakthrough in cancer treatment.
• The novel therapy, which uses modified herpesvirus to selectively target and destroy brain cancer cells, demonstrated a remarkable 92.3% one-year survival rate in clinical trials.
• The treatment, designed for malignant glioma patients with recurring tumors, showed a median survival period of 20 months, substantially exceeding traditional treatment outcomes.
T-VEC Shows Promise as Neoadjuvant Therapy for Basal Cell Carcinoma
• A Phase II trial of Talimogene laherparepvec (T-VEC) demonstrated efficacy in reducing tumor size in patients with cutaneous basal cell carcinoma (BCC).
• The study showed that T-VEC treatment led to improved surgical resectability and, in some cases, complete tumor regression, simplifying surgical procedures.
• T-VEC was well-tolerated, with minimal adverse events, and induced a robust immune response within the tumor microenvironment, enhancing immune cell infiltration.
• These findings suggest T-VEC could be a promising neoadjuvant option for BCC, especially when extensive surgery is a concern, warranting further investigation.
Breakthrough in Cancer Therapy: Modified Virus Shows Promise in Shrinking Tumors
A groundbreaking study reveals a modified virus therapy, NDV-GT, has shown significant promise in shrinking or halting the growth of tumors in patients with various types of advanced cancer. This innovative approach, leveraging a genetically modified Newcastle disease virus, marks a potential new direction in cancer treatment, especially for cases resistant to standard therapies. The therapy is now advancing to phase two and three clinical trials, offering hope for millions affected by cancer annually.
Neoadjuvant T-VEC Therapy Shows Promise in Treating Difficult-to-Resect Basal Cell Carcinoma
A recent study highlights the efficacy and tolerability of neoadjuvant therapy with Talimogene laherparepvec (T-VEC) in treating difficult-to-resect basal cell carcinoma (BCC). The therapy led to significant tumor size reduction, enabling simpler surgical procedures and achieving a complete pathological remission in some patients. The study also noted a strong immune cell response and significant changes in the intratumoral immune cell composition, suggesting T-VEC's potential as a safe and effective treatment alternative.
Nivolumab/Relatlimab Combination Demonstrates Sustained Overall Survival Benefit in Advanced Melanoma
• Extended analysis of the RELATIVITY-047 trial shows nivolumab/relatlimab significantly improves overall survival compared to nivolumab alone in advanced melanoma patients.
• Median overall survival reached 51.0 months with the combination therapy versus 34.1 months with nivolumab monotherapy, indicating a substantial survival advantage.
• The study also reported improved progression-free survival and melanoma-specific survival with the nivolumab/relatlimab combination.
• No new safety signals were identified, reinforcing the combination's manageable safety profile in previously untreated advanced melanoma.
Oncolytic Virus and Toripalimab Combination Shows Promise in Acral Melanoma
• A phase Ib trial of neoadjuvant oncolytic virus OrienX010 combined with toripalimab in resectable acral melanoma (AM) demonstrated a 77.8% pathological response rate.
• The 1-year and 2-year recurrence-free survival (RFS) rates were 85.2% and 81.5%, respectively, significantly higher than historical RFS rates for adjuvant therapy alone in AM.
• The combination therapy significantly increased the secretion of cytokines critical for tumor elimination, suggesting enhanced immune cell activity and improved sensitivity to immunotherapy.
• The study suggests that adjuvant therapy may not be necessary for AM patients with major pathological response after neoadjuvant treatment, warranting further exploration in future trials.
Advances in the Clinical Development of Oncolytic Viruses
This article reviews the progress in clinical trials of oncolytic viruses (OVs) for cancer treatment, highlighting their safety, effectiveness, and the challenges faced in their development. OVs selectively infect and kill cancer cells without harming normal cells, showing promise in treating various tumors with mild adverse events.
Oncolytic Virus Therapy Emerges as Promising Cancer Treatment Breakthrough
• Oncolytic virus therapy shows remarkable potential in cancer treatment by selectively targeting and destroying cancer cells while activating immune responses, marking a significant advancement in immunotherapy.
• Recent clinical trials demonstrate that combining oncolytic viruses with checkpoint inhibitors, such as Amgen's Imlygic with Keytruda, achieved a 62% response rate in melanoma patients.
• Major pharmaceutical companies are heavily investing in oncolytic virus platforms, with Janssen's $1 billion acquisition of BeneVir BioPharm and Merck's $400 million purchase of Viralytics highlighting industry confidence.
Oncolytic Viruses Gain Momentum in Cancer Treatment Following Merck's $394M Viralytics Acquisition
• Merck & Co's $394 million acquisition of Viralytics signals growing interest in oncolytic viruses as potential enhancers for cancer immunotherapy treatments.
• With 10 oncolytic viruses in clinical development and 40 in labs, these agents show promise in 'priming' tumors for checkpoint inhibitor therapy, potentially improving response rates.
• Targovax emerges as a leading independent biotech in the oncolytic virus space, developing TG01 for pancreatic cancer and ONCOS-102 for mesothelioma in partnership with AstraZeneca's MedImmune.
Drug Development Updates
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