FDA Approves IMLYGIC™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US
FDA Approves IMLYGIC™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US
THOUSAND OAKS, CA, USA I October 27, 2015 I
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for IMLYGIC™ (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
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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."
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.
Important Safety Information
Contraindications
- Do not administer IMLYGIC™ to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
- Do not administer IMLYGIC™ to pregnant patients.
Warnings and Precautions
- Accidental exposure to IMLYGIC™ may lead to transmission of IMLYGIC™ and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
- Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
- To prevent possible inadvertent transfer of IMLYGIC™ to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
- Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC™treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
- Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
- IMLYGIC™ is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC™. Consider the risks and benefits of IMLYGIC™ treatment before administering antiviral agents to manage herpetic infection.
- Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC™ treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
- Impaired healing at the injection site has been reported. IMLYGIC™ may increase the risk of impaired healing in patients with underlying risk factors (e.g., previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
- Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC™. Consider the risks and benefits of IMLYGIC™ before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
- Plasmacytoma at Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC™ administration in a clinical study. Consider the risks and benefits of IMLYGIC™ in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Adverse Reactions
- The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC™-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC™ treatment, but were more frequent during the first 3 months of treatment.
- The most common Grade 3 or higher adverse reaction was cellulitis.
Please see full Prescribing Information, including Medication Guide, for IMLYGIC at www.Amgen.com and www.IMLYGIC.com.