Amgen announced the initiation of a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck’s U.S. Food and Drug Administration (FDA) approved, anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.
“Data from this trial will help us further understand the safety and efficacy that comes from combining two immunotherapeutic agents,” said F. Stephen Hodi, M.D., director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute and Steering Committee Chair for this study. “Talimogene laherparepvec is designed to promote tumor antigen release and presentation to initiate an anti-tumor immune response, which may be complementary to keytruda’s role in releasing PD-1 pathway-mediated inhibition of anti-tumor 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.”
“This new trial underscores our commitment to researching different treatment approaches for patients with this aggressive and highly recurrent form of skin cancer,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are excited to partner with Merck and explore the potential of talimogene laherparepvec and keytruda. This will also give us insights into talimogene laherparepvec beyond the monotherapy setting, where a Phase 3 trial has shown encouraging results.”
“Merck is advancing the study of immuno-oncology combinations with keytruda across a broad range of malignancies,” said Dr. Eric Rubin, vice president, Clinical Development for Oncology, Merck Research Laboratories. “We are pleased to collaborate with Amgen to evaluate the potential of keytruda and talimogene laherparepvec as a combination regimen for the treatment of advanced melanoma.”
Filed Under: Drug Discovery