Amgen has announced it will initiate a clinical trial of talimogene laherparepvec, an investigational immunotherapy, in combination with Merck’s KEYTRUDA (pembrolizumab), in patients diagnosed with regionally or distantly metastatic melanoma.
The study has already enrolled its first patient and aims to test this combination therapy in 110 patients over 35 different 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,” 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, said in a press release. “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.”
Talimogene laherparepvec has the capacity to divide inside tumor cells, maintaining healthy cells intact and allowing an efficient immune response towards targeted cancer cells that have spread throughout the body.
This drug is injected into tumors, forcing the malignant cells to burst (lyse). This type of cell death releases several different types of tumor antigens, which will then be recognized by T cells, stimulating a systemic immune response that can eliminate metastatic cancer cells.
KEYTRUDA is a monoclonal antibody that can block the PD-L1 negative co-stimulatory receptor found on the surface of tumor cells. Upon binding to its PD-1 receptor, present in activated T lymphocytes, these ligands inhibit the effector function of immune cells, allowing cancer cells to proliferate without an effective immune surveillance.
“This new trial underscores our commitment to researching different treatment approaches for patients with this aggressive and highly recurrent form of skin cancer,” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen added in the press release. “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.”
Amgen’s multicenter, open-label clinical trial intends to assess the safety and efficacy of combining talimogene laherparepvec with KEYTRUDA versus KEYTRUDA as a monotherapy in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma.
“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.”
Importantly, talimogene laherparepvec has seen its Biologics License Application accepted for review by the FDA along with a Marketing Authorization Application in the European Union for the treatment of patients with regionally or distantly metastatic melanoma.