AmgenAmgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for IMLYGICTM (talimogene laherparepvec), 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. IMLYGIC is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study.(1-3)

IMLYGIC is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). IMLYGIC causes cell lysis, or death, which ruptures tumors, releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown.

"IMLYGIC is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer. Not all melanoma patients currently benefit from available therapies, and IMLYGIC represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Immunotherapy is an exciting area for cancer research, and we are currently studying IMLYGIC in combination with other immunotherapies in advanced melanoma and other solid tumors."

"Advanced melanoma remains a complex disease to treat, requiring the use of several modalities over the course of a patient's therapeutic journey," said Howard L. Kaufman, M.D., the principal investigator for the pivotal trial (OPTiM), associate director for Clinical Science at the Rutgers Cancer Institute of New Jersey and president of the Society for Immunotherapy of Cancer. "As an oncolytic viral therapy, IMLYGIC has a unique approach, and provides another option for treating eligible patients with unresectable disease that has recurred after initial surgery."

Metastatic melanoma continues to be one of the most difficult-to-treat cancers because it is often insensitive to chemotherapy, can be highly aggressive and can require several different types of treatment depending on the stage and location of the disease and health of the patient.(4,5) Despite new therapeutic options, additional treatments are needed - particularly for patients with metastatic disease.

Amgen intends to make IMLYGIC available to patients in the U.S. within a week. Amgen anticipates the average cost of IMLYGIC therapy to be approximately $65,000. Given that IMLYGIC represents a novel and first-in-class oncolytic viral therapy, Amgen expects variability of IMLYGIC dosing from patient to patient. Therefore, Amgen intends to work with the healthcare community to implement a program that helps limit the average cost of IMLYGIC therapy to $65,000 for eligible participating institutions.

Amgen is committed to helping clinically appropriate patients access our medicines and will provide assistance for IMLYGIC in the U.S. in the following ways:

  • Free medicines through The Safety Net Foundation are available to qualifying individuals with no or limited drug coverage.
  • Co-pay coupon program for IMLYGIC through the Amgen FIRST STEPTM Program to help commercially insured patients meet their co-payment obligations; this program has no income requirement.
  • Information about independent co-pay assistance foundations that give grants to qualifying patients who have difficulty paying out-of-pocket costs for medicines manufactured from across all of the industry.

About the OPTiM Study
The approval of IMLYGIC is based on data from Study 005/05, referred to as OPTiM. OPTiM was a Phase 3, multicenter, open-label, randomized clinical trial comparing IMLYGIC 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), defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of six months.

OPTiM enrolled 436 patients. In the study, 16.3 percent of patients treated with IMLYGIC achieved a durable response compared to 2.1 percent of patients treated with GM-CSF (p <0.0001). Of the patients who experienced a durable response, 29.1 percent had a durable CR and 70.8 percent had a durable PR. In the study, the median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC arm.

The most common adverse drug reactions in IMLYGIC treated patients 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 grade 3 or higher adverse reaction was cellulitis.(2)

About IMLYGIC (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex virus type 1 injected directly into tumors where it replicates inside tumors and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the tumor to rupture and die in a process called lysis. The rupture of the tumor causes the release of tumor-derived antigens, which together with virally-derived GM-CSF may promote an anti-tumor immune response. However, the exact mechanism of action is unknown and being further investigated.

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.

1. Review of FDA hematology/oncology approvals from March 2013 to September 13, 2015 via Accessed September 14, 2015.
2. Andtbacka, H et al. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015:2812-2814.
3. Lawler SE, Chiocca EA. Oncolytic Virus-Mediated Immunotherapy: A Combinatorial Approach for Cancer Treatment. J Clin Oncol. 2015;33(25):2812-4.
4. American Cancer Society. Melanoma Skin Cancer. Accessed October 14, 2015.
5. Faruk Tas. Metastatic Behavior in Melanoma: Timing, Pattern, Survival, and Influencing Factors. J Oncol, 2012; 2012: 647684.