New Trial Initiated Evaluating Amgen's Talimogene Laherparepvec In Combination With Merck's Anti-PD-1 Therapy KEYTRUDA® (Pembrolizumab) For Advanced Melanoma
"Data from this trial will help us further understand the safety and efficacy that comes from combining two immunotherapeutic agents," said
"This new trial underscores our commitment to researching different treatment approaches for patients with this aggressive and highly recurrent form of skin cancer," said
"Merck is advancing the study of immuno-oncology combinations with KEYTRUDA across a broad range of malignancies," said Dr.
A Biologics License Application has recently been accepted for review by the
The regulatory filings included data from more than 400 patients and is based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of intralesional talimogene laherparepvec in patients with stage IIIB, IIIC, or IV melanoma that are not surgically resectable compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). An
About the Combination Trial
The multicenter, open-label clinical trial is designed to evaluate the safety of talimogene laherparepvec in combination with KEYTRUDA, as well as the efficacy of this combination versus KEYTRUDA alone and following progression after treatment with KEYTRUDA alone.
The study will be conducted in two phases:
- Phase 1 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 randomized phase will further evaluate the safety and efficacy of talimogene laherparepvec in combination with KEYTRUDA.
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
Access to Investigational Medicines
To serve patients,
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year.2 In the U.S., while melanoma accounts for less than five percent of skin cancer cases, it causes the most skin cancer deaths.3 The number of new cases of melanoma in the U.S. has been increasing for the last 30 years.3
Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs such as the lymph nodes, lungs or other parts of the body distant from the primary tumor site.4
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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CONTACT: Amgen Thousand Oaks
Programme. http://www.who.int/uv/faq/skincancer/en/index1.html. Accessed July 18, 2014.
3. Melanoma skin cancer overview.
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