THOUSAND OAKS, Calif.,
Nov. 16, 2015 /PRNewswire/
-- 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.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
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we or us) and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially
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Inc.'s most recent annual report on Form 10-K and any subsequent
periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen
Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional
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business. Unless otherwise noted, Amgen is providing this
information as of Nov. 16, 2015, and
expressly disclaims any duty to update information contained in
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No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
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candidate or development of a new indication for an existing
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Further, preclinical results do not guarantee safe and effective
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
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