OREANDA-NEWS. November 18, 2015. 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:

  • Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma (G. Long)

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:

  • Safety profile of talimogene laherparepvec (T-VEC) in OPTiM, a phase 3 trial for melanoma (F. Collichio)
  • Long-term follow up from the phase 2 study of talimogene laherparepvec (T-VEC) for metastatic melanoma (J. Nemunaitis)
  • Durable-response (DR)-associated benefits in patients (pts) with unresected stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) or GM-CSF in OPTiM (H. Kaufman)
  • Durable complete responses (CR) in patients (pts) with stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) in OPTiM(R. Andtbacka)
  • Reduced risk of developing visceral/bone metastasis (VM) in patients (pts) with stage IIIB/C/IVM1a melanoma treated with talimogene laherparepvec (T-VEC) vs GM-CSF (R. Andtbacka)
  • Did patients in OPTiM have truly unresectable disease? Results of an independent review (M. Faries)
  • Current treatment patterns in patients with metastatic melanoma: A retrospective claims database analysis in the United States (U.S.) (Y. Chen)

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

  • 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 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. 

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

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