THOUSAND OAKS, Calif.,
Nov. 9, 2020 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced the first presentation
of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or
refractory small cell lung cancer (SCLC). AMG 757 is an
investigational half-life extended (HLE) bispecific T cell engager
(BiTE®) molecule targeting delta-like ligand 3 (DLL3).
The DLL3 protein is overexpressed on the cell surface of SCLC
tumors and minimally expressed in normal tissues.1
Data will be featured during a live oral presentation on
Nov. 12 at the Society for
Immunotherapy of Cancer's (SITC) 35th Annual Meeting
being held virtually.
"These AMG 757 proof of concept data in small cell lung cancer
and the recently presented AMG 160 data in prostate cancer provide
encouraging evidence of the BiTE platform's clinical activity in
solid tumors," said David M. Reese,
M.D., executive vice president of Research and Development at
Amgen. "AMG 757 is a half-life extended BiTE immuno-oncology
molecule targeting DLL3, which is an attractive target due to its
differential expression in small cell lung cancer. Small cell lung
cancer is a large unmet medical need globally, and yet treatment
options have not advanced significantly in decades."
This interim analysis of the Phase 1 dose escalation study
evaluated 40 patients with relapsed/refractory SCLC at a dose of up
to 10 mg every two weeks. In this study, AMG 757 demonstrated an
acceptable safety profile and showed preliminary evidence of
anti-tumor activity. Among 38 patients with evaluable disease, 16%
(6) had confirmed partial response, 29% (11) had stable disease,
and 3% (1) had unconfirmed partial response. Five of the six
responses are on-going with a median follow-up of 8.8 months. The
maximum tolerated dose for AMG 757 has not been reached and dosing
optimization is ongoing.
Cytokine release syndrome (CRS) was the most common
treatment-related adverse event (AE) reported in 43% (17) of
patients. All CRS events were grade 1 (30%) or 2 (13%), typically
occurred in cycle 1, and did not recur in subsequent cycles. All
CRS events were reversible, manageable, and did not lead to
treatment interuptions or discontinations.
"Small cell lung cancer is an aggressive cancer resulting in
poor prognosis for patients. Current platinum-based chemotherapy
and immunotherapy options have limited benefit in patients with
small cell lung cancer, leaving patients in need of novel
therapeutic options," said Hossein
Borghaei, DO, MS, chief of thoracic medical oncology at Fox
Chase Cancer Center. "These early data of AMG 757 are encouraging
for a BiTE immuno-oncology molecule that targets DLL3 in small cell
lung cancer."
Additional Data Presentations
Data on
IMLYGIC® (talimogene laherparepvec) will be featured
during an oral presentation. Data on AMG 404, AMG 160,
and AMG 509 will be presented as poster presentations. More
information can be found on the SITC website here.
About BiTE® Technology
BiTE® (bispecific T cell engager) technology is a
targeted immuno-oncology platform that is designed to engage
patient's own T cells to any tumor-associated antigen, activating
the cytotoxic potential of T cells to eliminate detectable cancer.
The BiTE immuno-oncology platform has the potential to treat
different tumor types through tumor-associated antigens. The BiTE
platform has a goal of leading to off-the-shelf solutions, which
have the potential to make innovative T cell treatment available to
all providers when their patients need it. Amgen is
advancing more than a dozen BiTE molecules across a broad range of
hematologic malignancies and solid tumors, further investigating
BiTE technology with the goal of enhancing patient experience and
therapeutic potential. To learn more about BiTE technology,
visit www.AmgenBiTETechnology.com.
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. The exact mechanism of action continues to be
investigated.
IMLYGIC is the first and only oncolytic viral therapy approved
by the U.S. Food and Drug Administration (FDA),
the European Medicines Agency (EMA), and other regulatory
authorities, based on therapeutic benefit demonstrated in a pivotal
Phase 3 study. IMLYGIC is indicated for the local treatment of
melanoma in patients with unresectable cutaneous, subcutaneous, or
nodal lesions after initial surgery.
The IMLYGIC clinical program continues to investigate the role
of IMLYGIC both as monotherapy and in combination with other
therapies across a variety of cancers and treatment settings.
INDICATION & LIMITATIONS OF USE
IMLYGIC® (talimogene laherparepvec) 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.
Limitations of use: 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 the 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.
- Obstructive Airway Disorder: Obstructive airway disorder has
been reported following IMLYGIC® treatment. Use
caution when injecting lesions close to major airways.
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 www.Imlygic.com for full Prescribing
Information, including Medication Guide.
About Amgen Oncology
Amgen Oncology is
searching for and finding answers to incredibly complex
questions that will advance care and improve lives for cancer
patients and their families. Our research drives us to understand
the disease in the context of the patient's life – not just their
cancer journey – so they can take control of their lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our
heritage, Amgen continues to advance the largest pipeline
in the Company's history, moving with great speed to advance those
innovations for the patients who need them.
At Amgen, we are driven by our commitment to transform the
lives of cancer patients and keep them at the center of everything
we do.
For more information, follow us
on www.twitter.com/amgenoncology.
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 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
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company, including BeiGene, Ltd. or
any collaboration or potential collaboration in pursuit of
therapeutic antibodies against COVID-19 (including statements
regarding such collaboration's, or our own, ability to discover and
develop fully-human neutralizing antibodies targeting SARS-CoV-2 or
antibodies against targets other than the SARS-CoV-2 receptor
binding domain, and/or to produce any such antibodies to
potentially prevent or treat COVID-19), or the Otezla®
(apremilast) acquisition (including anticipated Otezla sales growth
and the timing of non-GAAP EPS accretion), as well as estimates of
revenues, operating margins, capital expenditures, cash, other
financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and
outcomes, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, or effects relating to studies of Otezla as a potential
treatment for COVID-19, and other such estimates and results.
Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
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events or otherwise.
No forward-looking statement can be guaranteed and actual
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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, including our devices, after they are
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Our results may be affected by our ability to successfully
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Such product candidates are not approved by the U.S. Food and Drug
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Saunders LR, et al. Sci Transl Med 2015;7:302ral36.
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