Talimogene laherparepvec is under clinical development by Amgen and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Talimogene laherparepvec’s likelihood of approval (LoA) and phase transition for Soft Tissue Sarcoma took place on 07 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Talimogene laherparepvec Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Talimogene laherparepvec overview

Talimogene laherparepvec (Imlygic) is a recombinant herpes simplex type-1 virus (HSV), acts as immunostimulating and antineoplastic agent. It is formulated as injectable suspension and solution for intralesional route of administration. Imlygic 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. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.

It is under development for the treatment of Kaposi sarcoma, cutaneous angiosarcoma, pleomorphic liposarcoma, locally advanced basal cell carcinoma, triple negative breast cancer, hepatocellular carcinoma, pancreatic cancer including metastatic pancreatic adenocarcinoma, non-small cell lung cancer, renal cell carcinoma, gastroesophageal cancer, pancreatic ductal adenocarcinoma, Merkel cell carcinoma, malignant pleural effusion, metastatic recurrent squamous cell carcinoma of head and neck of the oral cavity, cutaneous squamous cell carcinoma, metastatic colorectal cancer with liver metastasis, metastatic breast cancer and other rare skin tumors, oropharynx, hypopharynx, or larynx, soft tissue sarcoma as second and third line therapy, and other solid tumors including inflammatory breast cancer. It is administered through intravesical, intratumor, intrapleural and intralesional route. It was also under development for non-muscle invasive transitional cell carcinoma (second line therapy), refractory T cell and NK cell lymphomas (cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL)), extramammary Paget Disease, cutaneous squamous cell carcinoma, non-melanomatous skin cancer.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

Quick View Talimogene laherparepvec LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Talimogene laherparepvec
Administration Pathway
  • Intralesional
  • Intrapleural
  • Intratumor
  • Intravesical
Therapeutic Areas
  • Infectious Disease
  • Oncology
  • Respiratory
Key Developers
  • Sponsor Company: Amgen
  • Originator: BioVex
Highest Development Stage
  • Marketed


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.