Amgen has started a Phase I trial of its investigational oncolytic immunotherapy ‘talimogene laherparepvec’ to treat patients with regionally or distantly metastatic melanoma.
The trial is designed to evaluate the safety of talimogene laherparepvec in combination with Merck’s FDA approved, anti-PD-1 therapy Keytruda, as well as the efficacy of this combination versus Keytruda alone and following progression after treatment with Keytruda alone.
Around 110 patients across 35 clinical trial sites in the US, Australia and Europe, will be enrolled in the multicentre, open-label clinical trial.
Dana-Farber Cancer Institute director of the Melanoma Centre and the Centre for Immuno-Oncology and Steering Committee chair for this study Stephen Hodi said: "Data from this trial will help us further understand the safety and efficacy that comes from combining two immunotherapeutic agents.
"Talimogene laherparepvec is designed to promote tumour antigen release and presentation to initiate an anti-tumour immune response, which may be complementary to Keytruda’s role in releasing PD-1 pathway-mediated inhibition of anti-tumour immune responses.
"Antigen release and presentation is a fundamental step required for mounting a systemic effect against melanoma, and we think there is a strong rationale for combining the oncolytic immunotherapy talimogene laherparepvec with the immune checkpoint inhibitor Keytruda."
The trial will be conducted in two phases, while the Phase I will determine the safety and tolerability of talimogene laherparepvec in combination with Keytruda in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma.
The randomised phase of the trial will further assess the safety and efficacy of talimogene laherparepvec in combination with Keytruda.
Amgen executive vice president of Research and Development Sean Harper said: "This new trial underscores our commitment to researching different treatment approaches for patients with this aggressive and highly recurrent form of skin cancer.
"This will also give us insights into talimogene laherparepvec beyond the monotherapy setting, where a Phase III trial has shown encouraging results."
Image: Lymph node with almost complete replacement by metastatic melanoma. Photo: courtesy of Gabriel Caponetti.