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European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe
Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7714251-amgen-imlygic-europe-approval/
IMLYGIC is derived from the herpes simplex type 1 virus (HSV-1) , commonly called the cold sore virus. IMLYGIC has been modified to replicate within tumors and to produce the immune stimulatory protein human granulocyte-macrophage colony-stimulating factor (GM-CSF). Administered via intralesional injection, IMLYGIC is designed to cause the death of tumor cells and initiate an anti-tumor immune response.
"As the first oncolytic immunotherapy authorized in the
Melanoma remains a significant public health concern in the
The European approval included a review of exploratory subgroup analyses of Study 005/05, referred to as
The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis. No fatal treatment-related adverse events occurred.5
This approval grants a centralized marketing authorization in the 28 countries that are members of the EU.
About the OPTiM Study
A key secondary endpoint was OS. In the intent-to-treat population, the median OS was 23.3 months in the group treated with IMLYGIC compared to 18.9 months for those treated with GM-CSF (p=0.0511). These results were not statistically significant. The ORR for patients in the intent-to-treat population was 26.4 percent for those treated with IMLYGIC compared to 5.7 percent in the GM-CSF arm. In an analysis to evaluate the systemic activity of IMLYGIC, 34 percent of patients in the intent-to-treat population had an overall decrease of at least 50 percent in non-visceral lesions that were not injected.
About IMLYGICTM (talimogene laherparepvec) in the EU
IMLYGIC is an oncolytic immunotherapy that is derived from HSV-1, which is commonly called the cold sore virus. IMLYGIC has been modified to replicate within tumors and to produce the immune stimulatory protein human GM-CSF. IMLYGIC causes the death of tumor cells and the release of tumor-derived antigens. It is thought that, together with GM-CSF, it will promote a systemic anti-tumor immune response and an effector T cell response.
Important EU Product Safety Information
This product is subject to additional monitoring. All suspected adverse reactions should be reported in accordance with the national reporting system.
The safety of IMLYGIC was evaluated in the pivotal study where 292 patients received at least one dose of IMLYGIC (see section 5.1). The median duration of exposure to IMLYGIC was 23 weeks (5.3 months). Twenty six (26) patients were exposed to IMLYGIC for at least one year.
The most commonly reported adverse reactions (≥ 25 percent) in IMLYGIC-treated patients were fatigue (50.3 percent), chills (48.6 percent), pyrexia (42.8 percent), nausea (35.6 percent), influenza-like illness (30.5 percent), and injection site pain (27.7 percent). Overall, ninety eight percent (98 percent) of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis (2.1 percent) (see section 4.4).
Please refer to the Summary of Product Characteristics for full European prescribing information.
About IMLYGIC™ (talimogene laherparepvec) in the U.S.
In the U.S., IMLYGIC is 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 U.S. Safety Information
- 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.
- The most commonly reported adverse drug reactions (≥ 25 percent) 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.
- A collaboration with Merck on developing IMLYGIC (talimogene laherparepvec) and KEYTRUDA® (pembrolizumab) Merck's anti-PD-1 therapy, in melanoma and squamous cell cancer of the head and neck.
- A collaboration with
Rocheon a Phase 1b study to evaluate the safety and efficacy of IMLYGIC in combination with Roche'sinvestigational anti-PDL1 therapy, atezolizumab (also known as MPDL3280A), in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
- A strategic research collaboration and license agreement to develop and commercialise the next generation of novel Chimeric Antigen Receptor (CAR) T-cell immunotherapies with
- A research collaborative agreement focusing on
Amgen'sbispecific T-cell engager (BiTE®) antibody constructs with MD Anderson's Moon Shots Program.
- A research and license agreement with
Xencorto develop and commercialise novel therapeutics in the areas of cancer immunotherapy and inflammation. The research collaboration brings together Amgen'scapabilities in target discovery and protein therapeutics with Xencor'sXmAb® bispecific technology platform.
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.
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while
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2. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in
4. Garbe C, Peris K, Hauschild A, et al. Diagnosis and treatment of melanoma. European consensus-based interdisciplinary guideline – Update 2012. Eur J Cancer. 2012;48:2375-90.
5. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015;33(25):2780-8.
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Amgen Thousand Oaks, Emma Gilbert, +41 41 369 2542 (media), Kristen Neese, 805-313-8267 (media), Kristen Davis, 805-447-3008 (media), Arvind Sood, 805-447-1060 (investors)