THOUSAND OAKS, Calif., Nov. 16, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Company will present eight IMLYGICTM (talimogene laherparepvec) abstracts, including data from the Phase 3 trial and new data from its Phase 1b combination trial with Merck's anti-PD-1 therapy, at the 12th International Congress of the Society for Melanoma Research (SMR), to be held on Nov. 18-21 in San Francisco.
"The analyses from our Phase 3 monotherapy trial confirm the clinical significance of durable responses and the benefit IMLYGIC may bring to patients living with metastatic melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "As we advance understanding in the emerging science of oncolytic viral therapy, we are also excited to share early data on the use of IMLYGIC in combination with another immunotherapy."
The Phase 1b data on IMLYGIC in combination with an investigational use of Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma (NCT02263508) has been accepted as a late-breaking abstract. The oral presentation is Saturday, Nov. 21, in Plenary Session 11 (Late Breaking Clinical Updates) between 1:30 to 3:40 p.m. PT in the San Francisco Marriott Marquis Salon 9-15:
Additionally, the Company will present analyses from OPTiM, the Phase 3 trial that served as the basis of the U.S. Food and Drug Administration's (FDA) approval of IMLYGIC in October 2015. The following will be presented on Thursday, Nov. 19, from 6 to 8 p.m. PT at the Poster Reception in the San Francisco Marriott Marquis Salon 1-8:
Abstracts are available on the SMR website at www.melanomacongress.com/abstracts.
About IMLYGIC™ (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. However, the exact mechanism of action is unknown.
IMLYGIC is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.
Important Safety Information
Contraindications
Warnings and Precautions
Adverse Reactions
Please see full Prescribing Information and Medication Guide for IMLYGIC™ at www.IMLYGIC.com.
About Amgen
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 one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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