Amgen, a multinational biopharmaceutical company, and Merck, known as MSD outside the United States and Canada, 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-PD-1 immunotherapy, in a phase 1b/2 study of patients with mid- to late-stage melanoma.
"Talimogene laherparepvec has shown encouraging phase 3 clinical results as a monotherapy in patients with metastatic melanoma," said David D. Chang, vice president of global development at Amgen. "We look forward to working with Merck on this collaboration to evaluate the potential of these two novel immunotherapies to improve clinical outcomes for patients."
"We are pleased to be collaborating with Amgen to study MK-3475 as part of this novel combination regimen," said Dr Eric Rubin, vice president, clinical development for oncology, Merck Research Laboratories. "Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer."
The multicenter, open-label clinical trial will be conducted in two parts and is planned to begin in the fall of 2014. Phase 1b 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 2 portion will evaluate efficacy, as assessed by the confirmed objective response rate (ORR), 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 tumour tissue and to initiate a systemic anti-tumour immune response. Talimogene laherparepvec is injected directly into tumour tissue and is intended to replicate preferentially in tumour cells causing lytic cell death and releasing an array of tumour-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-tumour immune response that targets tumour cells throughout the body.
Many tumours 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 that target cancer by essentially releasing a brake on the immune system.
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