THOUSAND OAKS, Calif.,
Sept. 12, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that new data from its
oncology portfolio and pipeline will be presented at the
17th International Myeloma Workshop (IMW) 2019 in
Boston, Sept. 12-15, 2019.
Data featured from Amgen's hematology franchise will include
oral presentations from Phase 1 studies of AMG 420, the anti-B-cell
maturation antigen (BCMA) bispecific T cell engager
(BiTE®) and AMG 176, the MCL-1 inhibitor in patients
with relapsed or refractory multiple myeloma. Other data being
presented will include safety and efficacy results of once-weekly
dosing of KYPROLIS® (carfilzomib) in different regimens
across several patient populations, and Phase 3 results from the
first KYPROLIS trial to be conducted in China.
"We are proud to build on the success of KYPROLIS and look to
advance the next generation of multiple myeloma therapies through
our evolving pipeline," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "We are excited by the initial results we
have seen in our ongoing BCMA BiTE program and are focusing our
efforts on the investigation of intermittent dosing paradigms that
don't involve continuous infusion. Our goal is to bring forward
effective molecules that have the greatest potential to provide
patient-friendly, convenient treatment options and support the
healthcare professionals who fight these difficult-to-treat
diseases."
A complete listing of abstracts can be found on the IMW website.
Notable abstracts of interest include:
Oncology Pipeline
- The Anti-BCMA Bispecific T-Cell Engager (BiTE) Molecule AMG
420 Induced MRD-Negative Complete Responses in R/R Multiple Myeloma
in a FIH Study
Abstract #OAB-025, Oral Presentation,
Friday, Sept. 13, at 2:30 p.m. ET in Veterans Auditorium
The Phase 1b study examining AMG
420 in patients with relapsed and/or refractory multiple myeloma is
ongoing. The Company is also exploring intermittent dosing options
with AMG 420 that could be evaluated following the Phase
1b study.
A Phase 1 dose escalation study of AMG 701, a half-life extended
anti-BCMA BiTE molecule that can be dosed intermittently is
underway with data expected for presentation in 2020.
- A Phase 1, First-in-Human Study of AMG 176, a Selective
MCL-1 Inhibitor, in Patients With Relapsed or Refractory Multiple
Myeloma
Abstract #OAB-080, Oral Presentation, Saturday, Sept. 14, at 4
p.m. ET in Hynes Ballroom
The Phase 1 dose escalation clinical trial for AMG 397
(NCT03465540) is on a clinical hold to evaluate a safety signal for
cardiac toxicity. In keeping with Amgen's commitment to patient
safety, the AMG 176 Phase 1 trial (NCT02675452) has been placed on
a voluntary hold for new enrollment.
KYPROLIS
- Safety and Efficacy of Once-Weekly Carfilzomib (K) Dosing in
Frail Patients (pts): A Subgroup Analysis from the Phase 3
A.R.R.O.W. Study
Abstract #OAB-046, Oral Presentation,
Saturday, Sept. 14, at 10:15 a.m. ET in Veterans Auditorium
- Efficacy and Safety of
Carfilzomib-Pomalidomide-Dexamethasone in Relapsed and/or
Refractory Multiple Myeloma: Pooled Analysis of 2 Single Arm
Studies
Abstract #OAB-049, Oral Presentation, Saturday, Sept. 14, at 11
a.m. ET in Veterans Auditorium
- A Phase 1b Study of
Once-Weekly Carfilzomib Combined with Lenalidomide and
Dexamethasone (wKRd) in Patients (pts) with Newly Diagnosed
Multiple Myeloma (NDMM)
Abstract #OAB-078, Oral Presentation, Saturday, Sept. 14, at 3:30 p.m. ET in Hynes Ballroom
- Trial in Progress: Once-Weekly vs. Twice-Weekly Dosing of
Carfilzomib-Lenalidomide-Dexamethasone in Patients w/ Relapsed or
Refractory Multiple Myeloma
Abstract #SP-114, Poster Session
II, Saturday, Sept. 14, from
12:30-2 p.m. ET in Hynes
Auditorium
- A Phase 3 Study of Carfilzomib and Dexamethasone (Kd) in
Patients with Relapsed and Refractory Multiple Myeloma (MM) in
China
Abstract #SP-115, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
- A Patient-Physician Tool to Improve CoMMunication in
Relapsed Refractory Multiple Myeloma (RRMM)
Abstract #SP-071, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
- Carfilzomib (K) in Relapsed and Refractory Multiple Myeloma
(RRMM): Frailty Subgroup Analysis from Phase 3 ASPIRE and
ENDEAVOR
Abstract #SP-113, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
- Real-World Use of Carfilzomib Therapy Among Patients with
Existing Cardiovascular Medical History: An Analysis of a
Prospective Observational Study
Abstract #SP-138, Poster
Session II, Saturday, Sept. 14, from
12:30-2 p.m. ET in Hynes
Auditorium
- Depth of Response and Outcomes by Initial Therapy Prior to
Autologous Hematopoietic Stem Cell Transplantation for Multiple
Myeloma
Abstract #SP-164, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
- Real-World Evidence of the Use of Carfilzomib and
Dexamethasone According to Age Subgroup: An Interim Analysis from a
Prospective Observational Study
Abstract #SP-139, Poster
Session II, Saturday, Sept. 14, from
12:30-2 p.m. ET in Hynes
Auditorium
Completion of the Phase 3 CANDOR study evaluating KYPROLIS in
combination with dexamethasone and DARZALEX®
(daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone in
patients with relapsed or refractory multiple myeloma is expected
in the second half of 2019.
About BiTE® Technology
Bispecific T cell
engager (BiTE®) technology is a targeted immuno-oncology
platform that is designed to engage patients' 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 leads 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.
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.
About KYPROLIS® (carfilzomib)
Proteasomes
play an important role in cell function and growth by breaking down
proteins that are damaged or no longer needed. KYPROLIS has
been shown to block proteasomes, leading to an excessive build-up
of proteins within cells. In some cells, KYPROLIS can cause
cell death, especially in myeloma cells because they are more
likely to contain a higher amount of abnormal proteins.
Since its first approval in 2012, approximately 130,000 patients
worldwide have received KYPROLIS. KYPROLIS is approved in the U.S.
for the following:
- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- As a single agent for the treatment of patients with relapsed
or refractory multiple myeloma who have received one or more lines
of therapy.
KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New
Zealand, Oman, Philippines, Qatar, Russia, Saudi
Arabia, Singapore, S.
Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab
Emirates and additional U.S. regulatory applications for
KYPROLIS are underway and have been submitted to health authorities
worldwide.
Important U.S. KYPROLIS® (carfilzomib) Safety
Information
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of administration.
- Monitor patients for signs or symptoms of cardiac failure or
ischemia. Evaluate promptly if cardiac toxicity is suspected.
Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until
recovery, and consider whether to restart at 1 dose level reduction
based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate.
- For patients ≥ 75 years, the risk of cardiac failure is
increased. Patients with New York Heart Association Class III and
IV heart failure, recent myocardial infarction, conduction
abnormalities, angina, or arrhythmias may be at greater risk for
cardiac complications and should have a comprehensive medical
assessment prior to starting treatment with KYPROLIS and remain
under close follow-up with fluid management.
Acute Renal Failure
- Cases of acute renal failure, including some fatal renal
failure events, and renal insufficiency adverse events (including
renal failure) have occurred. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred. Patients with a high tumor burden should be
considered at greater risk for TLS. Adequate hydration is required
prior to each dose in Cycle 1, and in subsequent cycles as needed.
Consider uric acid lowering drugs in patients at risk for TLS.
Monitor for evidence of TLS during treatment and manage promptly,
and withhold until resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred. Some
events have been fatal. In the event of drug‐induced pulmonary
toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported. Evaluate
with cardiac imaging and/or other tests as indicated. Withhold
KYPROLIS for PAH until resolved or returned to baseline and
consider whether to restart based on a benefit/risk
assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart based on a benefit/risk assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed, some fatal. Control hypertension
prior to starting KYPROLIS. Monitor blood pressure regularly in all
patients. If hypertension cannot be adequately controlled, withhold
KYPROLIS and evaluate. Consider whether to restart based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed. Thromboprophylaxis is
recommended for patients being treated with the combination of
KYPROLIS with dexamethasone or with lenalidomide plus
dexamethasone. The thromboprophylaxis regimen should be based on an
assessment of the patient's underlying risks.
- Patients using hormonal contraception associated with a risk of
thrombosis should consider an alternative method of effective
contraception during treatment.
Infusion Reactions
- Infusion reactions, including life‐threatening reactions, have
occurred. Symptoms include fever, chills, arthralgia, myalgia,
facial flushing, facial edema, vomiting, weakness, shortness of
breath, hypotension, syncope, chest tightness, or angina. These
reactions can occur immediately following or up to 24 hours after
administration. Premedicate with dexamethasone to reduce the
incidence and severity of infusion reactions. Inform patients of
the risk and of symptoms and seek immediate medical attention if
they occur.
Hemorrhage
- Fatal or serious cases of hemorrhage have been reported.
Hemorrhagic events have included gastrointestinal, pulmonary, and
intracranial hemorrhage and epistaxis. Promptly evaluate signs and
symptoms of blood loss. Reduce or withhold dose as
appropriate.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle. Monitor
platelet counts frequently during treatment. Reduce or withhold
dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have occurred.
KYPROLIS can cause increased serum transaminases. Monitor liver
enzymes regularly regardless of baseline values. Reduce or withhold
dose as appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred. Monitor for signs and
symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the
diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The
safety of reinitiating KYPROLIS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS. If
PRES is suspected, discontinue and evaluate with appropriate
imaging. The safety of reinitiating KYPROLIS is not known.
Increased Fatal and Serious Toxicities in Combination with
Melphalan and Prednisone in Newly Diagnosed
Transplant-ineligible Patients
- In a clinical trial of transplant-ineligible patients with
newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and
prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a
higher incidence of serious and fatal adverse events was observed
in patients in the KMP arm. KMP is not indicated for
transplant-ineligible patients with newly diagnosed multiple
myeloma.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS and for 6
months following the final dose. Males of reproductive potential
should be advised to avoid fathering a child while being treated
with KYPROLIS and for 3 months following the final dose. If this
drug is used during pregnancy, or if pregnancy occurs while taking
this drug, the patient should be apprised of the potential hazard
to the fetus.
ADVERSE REACTIONS
- The most common adverse reactions in the combination therapy
trials: anemia, neutropenia, diarrhea, dyspnea, fatigue,
thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper
respiratory tract infection, hypokalemia.
- The most common adverse reactions in monotherapy trials:
anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea,
diarrhea, headache, cough, edema peripheral
Please see full Prescribing Information
at www.kyprolis.com.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
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Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
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Amgen is providing this information as of the date of this news
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No forward-looking statement can be guaranteed and actual
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Further, preclinical results do not guarantee safe and effective
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CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(Media)
Arvind Sood, 805-447-1060
(Investors)
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