Amgen announced the initiation of a clinical trial, NCT02366195, to determine whether baseline CD8+ T lymphocytes density is a biomarker of response to talimogene laherparepvec, an investigational oncolytic immunotherapy, in patients with unresected stages IIIB to IV melanoma. The first subject has enrolled into the study, with the goal of including approximately 110 patients across 49 clinical trial sites in 11 different countries in Europe.
CD8+ T lymphocytes are also known as killer, or cytotoxic T lymphocytes that express CD8 on the cell surface. CD8+ T lymphocytes are a critical component of the cellular immune response and they play a central role in destroying cancer cells and cells infected with viruses.
“Tumour-infiltrating CD8+ T cells are frequently associated with favourable clinical outcomes in a spectrum of cancers and we hope this trial will help us find those patients for whom talimogene laherparepvec may be most beneficial,” said study investigator, Dr Josep Malvehy, director of the Melanoma Unit, Dermatology Department, Hospital Clinic of Barcelona in Spain. “We expect the role of immunological biomarkers to increase significantly in the next few years, enabling personalised anti-cancer immunotherapy with optimal treatment selection for individual tumours, which is important for patients.”
“We now know that infiltration of tumours by CD8+ T lymphocytes is emerging as a prognostic marker in many tumour types and may be predictive for response to immunotherapies. With this new study, we are excited to learn whether the change in the density of infiltrating intratumoural CD8 compared to baseline after talimogene laherparepvec treatment may help identify patients with regionally and distantly metastatic melanoma who might benefit from this treatment,” said David Reese, MD, senior vice president of Translational Sciences at Amgen. “Studies such as these are the important first step required to investigate potential prognostic and predictive biomarkers in patients who may respond to talimogene laherparepvec.”
A Biologics Licence Application (BLA) and a marketing authorisation application for talimogene laherparepvec for the treatment of patients with regionally or distantly metastatic melanoma was accepted for review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. Amgen recently announced that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the FDA will jointly review the Company’s BLA for talimogene laherparepvec.
The regulatory filings included data from more than 400 patients treated with talimogene laherparepvec and are based on a global, randomised, open-label Phase III trial evaluating the safety and efficacy of intralesional talimogene laherparepvec in patients with unresected stage IIIB, IIIC, or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).
