THOUSAND OAKS, Calif.,
Dec. 5, 2020 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced the first presentation
of clinical safety and efficacy data from the Phase 1 study of AMG
701 in heavily pre-treated patients with relapsed/refractory
multiple myeloma (R/R MM). AMG 701 is an investigational half-life
extended (HLE) bispecific T cell engager (BiTE®)
immuno-oncology therapy targeting B-cell maturation antigen (BCMA).
The data will be presented during a live oral presentation on
Dec. 5 at the virtual 62nd
American Society of Hematology (ASH) Annual Meeting &
Exposition.
"The emerging data from the BiTE platform in hematological
malignancies are encouraging. Previously, Amgen provided important
evidence for BCMA-directed BiTE molecules as a therapeutic approach
in multiple myeloma. AMG 701 continues to show the potential of
that strategy in patients who are heavily pre-treated," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen.
"These data are the latest in a series that reinforce both the
potential versatility of the BiTE platform and Amgen's commitment
to developing innovative medicines for novel targets in
difficult-to-treat cancers," Reese continued. "This year alone,
Amgen has presented proof-of-concept data for four BiTE®
molecules in hematological malignancies and solid tumors, and we
are proud to end the year with these data in multiple myeloma at
ASH."
This interim analysis of the Phase 1 dose escalation study
evaluated AMG 701 in 85 R/R MM patients who had received at least
three prior lines of therapy, and a median of six lines. The
response rate was 36% at doses of 3-18 mg with responses lasting up
to 26 months in one patient. Six of seven patients, who were tested
for minimal residual disease (MRD), were MRD-negative. In the most
recent evaluable cohort, there was an 83% ORR, with 4/5 responders
being triple refractory.
"Despite advances in the treatment of multiple myeloma, there
remains an unmet need for patients with this difficult-to-treat
disease who have relapsed or refractory disease following current
standard therapies," said Professor Simon
J. Harrison, director of the Centre of Excellence in
Cellular Immunotherapy, Peter MacCallum Cancer Centre and Royal
Melbourne Hospital, Melbourne,
Australia. "These first-in-human data show that AMG 701, a
half-life extended BiTE therapy targeting BCMA, has encouraging
signs of activity as a single agent in this heavily pre-treated
patient population."
The most common hematological adverse events (AEs) were anemia
(42%), neutropenia (25%) and thrombocytopenia (21%). The most
common non-hematological AEs were cytokine release syndrome (CRS,
65%), diarrhea (31%) and hypophosphatemia (31%). CRS was mostly
grade 1 (27%) or 2 (28%) based on Lee
Blood 2014 criteria. All Grade 3 CRS events (9%) were
reversible with mitigation procedures outlined in the study
protocol, with a median duration of two days.
Learn more about Amgen's development of innovative
medicines for novel targets in difficult-to-treat tumors
at AmgenOncology.com/medical, and follow Amgen Oncology on
Twitter and LinkedIn.
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-specific 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-specific 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 Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by
a recurring pattern of remission and relapse.1 It
is a rare and life-threatening disease that accounts for
approximately one percent of all
cancers.2,3 Worldwide, approximately 160,000 people
are diagnosed with multiple myeloma each year, and 106,000 patient
deaths are reported on an annual basis.2
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
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including any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other
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(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,
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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
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involve significant risks and uncertainties, including those
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recent annual report on Form 10-K and any subsequent periodic
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No forward-looking statement can be guaranteed and actual
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Our results may be affected by our ability to successfully
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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
- Kumar S., et al. NCCN Guidelines Insights: Multiple
Myeloma. The Journal of the National Comprehensive Cancer
Network. Jan 2018; Volume
16: Issue 1. https://doi.org/10.6004/jnccn.2018.0002.
- Jakubowiak A. Management strategies for relapsed/refractory
multiple myeloma: current clinical perspectives. Semin
Hematol. 2012 Jul; 49 Suppl 1: S16-S32.
- GLOBOCAN 2018. Multiple Myeloma. Available
at: http://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf.
Accessed November 9, 2020.
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