Talimogene laherparepvec is under clinical development by Amgen and currently in Phase II for Gastroesophageal (GE) Junction Carcinomas. According to GlobalData, Phase II drugs for Gastroesophageal (GE) Junction Carcinomas have a 28% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Talimogene laherparepvec’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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,HER2 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, 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 triple negative breast cancer, malignant pleural effusion, 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 for the treatment of cardiovascular conditions, oncology/hematology, inflammation, bone health, neurological disorders and nephrology conditions. The company analyzes the difficulties of disease and understands the fundamentals of human biology to develop products harnessing advanced human genetics. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has a presence in Asia Pacific, Europe, the Middle East, the Americas and Australia. Amgen is headquartered in Thousand Oaks, California, the US.
For a complete picture of Talimogene laherparepvec’s drug-specific PTSR and LoA scores, buy the report here.
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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
