Amgen To Discuss Details Of The Biologics License Application For Talimogene Laherparepvec For Patients With Metastatic Melanoma

Joint FDA Advisory Committee to Review Phase 3 Data for a Potential First-in-Class Oncolytic Immunotherapy

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Apr 29, 2015, 08:00 ET

THOUSAND OAKS, Calif., April 29, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Company will discuss the data supporting the Biologics License Application (BLA) for talimogene laherparepvec monotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma at today's joint meeting of the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and Oncologic Drugs Advisory Committee (ODAC).

At the meeting, Amgen will present the results of the pivotal Phase 3 OPTiM study, which showed that talimogene laherparepvec monotherapy is the first oncolytic immunotherapy to demonstrate therapeutic benefit in a Phase 3 pivotal trial for patients with metastatic melanoma.

"The incidence of melanoma, the most serious form of skin cancer, has continued to rise over the last 30 years, even as many other cancers are in decline," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite recent advances, there is still an unmet need in this disease. For this reason, today's discussion about talimogene laherparepvec for the treatment of patients with metastatic melanoma is important. If approved, this novel agent could provide physicians and patients with an additional treatment option for this disease."

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 granulocyte-macrophage colony-stimulating factor (GM-CSF), which 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.

Amgen has in place a comprehensive clinical development program for talimogene laherparepvec in metastatic melanoma, which includes combination studies with checkpoint inhibitors in patients with late-stage disease and monotherapy prior to surgery (neoadjuvant) in patients with resectable disease. Additionally, based on its clinical profile, talimogene laherparepvec has the potential to be studied in a variety of solid tumor types.

According to the American Cancer Society, with an estimated 74,000 new melanoma diagnoses and nearly 10,000 deaths this year¹, melanoma remains a significant public health concern in the U.S. Additionally, metastatic melanoma continues to be one of the most difficult to treat cancers because it is highly aggressive and complex. Despite recent treatment advances, the five-year survival rate for melanoma is only 20 percent², so additional safe and effective treatment options are needed.

OPTiM Study Design and Results
Study 005/05, referred to as OPTiM, was a Phase 3, multicenter, open-label, randomized clinical trial comparing talimogene laherparepvec to GM-CSF in patients with advanced melanoma (stage IIIB, IIIC, or IV) that was not surgically resectable. The primary endpoint of the study was durable response rate (DRR).

In the 436-patient study, talimogene laherparepvec significantly improved DRR with 16.3 percent of talimogene laherparepvec patients achieving a complete response (CR) or partial response (PR) within the first 12 months of treatment and maintaining it continuously for at least six months compared to 2.1 percent of patients treated with GM-CSF (p <0.001).

The OPTiM study also provided additional secondary and exploratory data that demonstrated the effects of talimogene laherparepvec in patients with Stage III/IV metastatic melanoma, including:

Improved overall (CR + PR) response rate compared with GM-CSF, 26.4 percent vs. 5.7 percent, respectively. In particular, the CR rate was higher in the talimogene laherparepvec arm than in the GM-CSF arm (10.8 percent vs. 0.7 percent, respectively).
A strong trend in overall survival (OS). The median OS was 4.4 months longer in the talimogene laherparepvec arm than in the GM-CSF arm (hazard ratio: 0.79; p=0.051).
Evidence of a systemic effect. Eight of 71 patients (11.3 percent) with visceral lesions that could not be injected (predominately in the lung and liver) had an overall decrease in those lesions of more than 50 percent.

The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection-site pain. Most adverse reactions reported were mild or moderate in severity and generally resolved within 72 hours. The most common serious adverse reaction was cellulitis.

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward Looking Statements
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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kelley Davenport, 202-585-9637 (media)
Arvind Sood, 805-447-1060 (investors)

References

1.	American Cancer Society. Cancer Facts & Figures 2014. http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics. Accessed April 13, 2015.
2.	American Cancer Society. Melanoma Skin Cancer. http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-survival-rates. Accessed April 13, 2015.