Amgen and Merck Collaborate on Combo Treatment for Advanced Melanoma
Clinical trial to begin in fall of 2014 (February 5)
Amgen and Merck have entered into an agreement through a subsidiary to evaluate the safety and efficacy of talimogene laherparepvec, an investigational oncolytic immunotherapy, combined with MK-3475, an investigational anti-programmed cell death protein 1 (anti–PD-1) immunotherapy, in a phase Ib/II study of patients with mid- to late-stage melanoma.
The open-label clinical trial will be conducted in two parts and is planned to begin in the fall of 2014. Phase Ib is designed to determine the safety and tolerability of talimogene laherparepvec in combination with MK-3475 in patients with previously untreated, unresected, stage IIIB to IVM1a melanoma. The phase II portion will evaluate efficacy, as assessed by the confirmed objective response rate, with talimogene laherparepvec in combination with MK-3475 versus MK-3475 alone in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. The study will also evaluate the efficacy of treatment with talimogene laherparepvec in combination with MK-3475 following disease progression on MK-3475 alone.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response. It is injected directly into tumor tissue and is intended to replicate preferentially in tumor cells, thereby causing lytic cell death and releasing tumor-derived antigens. Talimogene laherparepvec is also engineered to express granulocyte-macrophage colony-stimulating factor (GM-CSF), a white blood cell growth factor, which can help to activate the immune system. The aim of this combination of actions is to initiate a systemic anti-tumor immune response that targets tumor cells throughout the body.
Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti–PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells, which target cancer by essentially releasing a brake on the immune system.
Source: Amgen; February 5, 2014.