CAMBRIDGE, Mass. & OSAKA, Japan - Monday, November 10th 2014 [ME NewsWire]
ASH 2014
(BUSINESS
WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) today
announced that abstracts of interest from studies on VELCADE®
(bortezomib), ADCETRIS® (brentuximab vedotin) and the investigational
oral proteasome inhibitor, ixazomib (MLN9708), are among those that have
been accepted for presentation at this year’s American Society of
Hematology (ASH) annual meeting to be held December 6-9, 2014 in San
Francisco, California.
Data selected for presentation include
results from the Phase 3 AETHERA clinical trial evaluating the potential
treatment of brentuximab vedotin, a CD30-targeted antibody drug
conjugate (ADC), as consolidation therapy immediately following an
autologous stem cell transplantation (ASCT) in patients with Hodgkin
lymphoma at high risk of relapse or progression. Other presentations
will feature long-term (four-year) survival data for ADCETRIS in
relapsed or refractory systemic Anaplastic Large Cell Lymphoma (sALCL)
and results from a Phase 2 study examining long-term maintenance therapy
with oral proteasome inhibitor ixazomib for patients with previously
untreated multiple myeloma (MM).
“The data to be presented at
this year’s ASH highlight the excellent progress we have made in
developing our oncology portfolio. The rapid advancement of the ixazomib
program over the last five years underscores the potential of this
investigational therapy in extending the power of proteasome
inhibition,” said Christophe Bianchi, M.D., President, Global Oncology
Business Unit, Takeda. “As ADCETRIS continues to expand its reach across
the globe and demonstrate the potential for benefit in new indications,
and VELCADE is featured in more than 120 presentations, we are excited
about our programs and our continued pursuit to improve the care of
patients who currently have limited treatment options.”
“The
treatment landscapes for patients with both relapsed or refractory
Hodgkin lymphoma as well as patients with systemic Anaplastic Large Cell
Lymphoma continue to evolve, and the data to be presented at ASH
suggest that ADCETRIS could be an important, and potentially
paradigm-changing therapy, for these patients,” said Michael
Vasconcelles, M.D., Head, Oncology Therapeutic Area Unit, Takeda.
“Further, the ixazomib data to be presented advance our understanding of
the established and important role of proteasome inhibition in the
treatment of multiple myeloma, and provides useful insight into the
long-term management of patients with previously untreated multiple
myeloma.”
Takeda’s abstracts of interest at ASH 2014 include:
Brentuximab Vedotin
The AETHERA Trial: Results of a Randomized, Double-Blind,
Placebo-Controlled Phase 3 Study of Brentuximab Vedotin in the Treatment
of Patients at Risk of Progression Following Autologous Stem Cell
Transplant for Hodgkin Lymphoma
Presenter: Craig H. Moskowitz, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY
Abstract 673, Oral Presentation, Monday, December 8, 2014, 4:30 PM, West Building, 3001-3003-3014-3016 (Moscone Center)
Four-Year Survival Data from an Ongoing Pivotal Phase 2 Study of
Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic
Anaplastic Large Cell Lymphoma
Presenter: Barbara Pro, M.D., Thomas Jefferson University, Philadelphia, PA
Abstract 3095, Poster Presentation, Sunday, December 7, 2014, 6:00 PM, West Building, Level 1 (Moscone Center)
Ixazomib
Long-Term Ixazomib Maintenance Is Tolerable and Improves Depth of
Response Following Ixazomib-Lenalidomide-Dexamethasone Induction in
Patients (Pts) with Previously Untreated Multiple Myeloma (MM): Phase 2
Study Results
Presenter: Shaji K. Kumar, M.D., Mayo Clinic, Rochester, MN
Abstract 82, Oral Presentation, Sunday, December 7, 2014, 12:45 PM, West Building, 2001-2003-2014-2016 (Moscone Center)
About VELCADE®
VELCADE®
(bortezomib) is co-developed by Millennium/Takeda and Janssen
Pharmaceutical Companies. Millennium is responsible for
commercialization of VELCADE in the U.S.; Janssen Pharmaceutical
Companies are responsible for commercialization in Europe and the rest
of the world. Takeda Pharmaceutical Company Limited and Janssen
Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in
more than 90 countries and has been used to treat more than 550,000
patients worldwide.
VELCADE: Important Safety Information
VELCADE®
(bortezomib) is approved for the treatment of patients with multiple
myeloma. VELCADE is also approved for the treatment of patients with
mantle cell lymphoma who have already received at least one prior
treatment.
Patients should not receive VELCADE if they are
allergic to bortezomib, boron or mannitol. VELCADE should not be
administered intrathecally. Women should avoid becoming pregnant or
breastfeeding while taking VELCADE. Patients with diabetes may require
close monitoring and adjustment of their medication. VELCADE can cause
serious side effects, including:
Peripheral neuropathy. Nerve
problems, which can be severe including muscle weakness, tingling,
burning, pain, or loss of feeling in the hands and feet.
Low blood pressure. A drop in blood pressure resulting in dizziness, light headedness or fainting.
Heart problems. Heart rhythm problems and heart failure including
worsening of existing conditions. Symptoms may include chest pressure or
pain, palpitations, swelling of the ankles or feet, or shortness of
breath.
Lung problems, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.
Liver problems. Liver failure including a yellow discoloration of the eyes and skin.
Posterior reversible encephalopathy syndrome (PRES). A rare, reversible
condition involving the brain. Symptoms may include seizures, high
blood pressure, headaches, tiredness, confusion, blindness, or other
vision problems
Gastrointestinal problems. Nausea, vomiting, diarrhea and constipation.
Thrombocytopenia and neutropenia. Lowering the levels of blood cells,
which could result in a higher risk for infections or bleeding.
Tumor lysis syndrome (TLS). TLSis a syndrome that causes a chemical
imbalance in the blood that could lead to heart and/or kidney problems.
Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, rash.
These
are not all of the possible side effects with VELCADE. Please see the
full Prescribing Information for VELCADE for a complete list available
at VELCADE.com.
About ADCETRIS®
ADCETRIS® (brentuximab
vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached
by a protease-cleavable linker to a microtubule disrupting agent,
monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary
technology. The ADC employs a linker system that is designed to be
stable in the bloodstream but to release MMAE upon internalization into
CD30-expressing tumor cells.
ADCETRIS for intravenous injection
received accelerated approval from the U.S. Food and Drug Administration
and approval with conditions from Health Canada for two indications:
(1) the treatment of patients with HL after failure of ASCT or after
failure of at least two prior multi-agent chemotherapy regimens in
patients who are not ASCT candidates, and (2) the treatment of patients
with sALCL after failure of at least one prior multi-agent chemotherapy
regimen. The indications for ADCETRIS are based on response rate. There
are no data available demonstrating improvement in patient-reported
outcomes or survival with ADCETRIS.
ADCETRIS was granted
conditional marketing authorization by the European Commission in
October 2012 for two indications: (1) for the treatment of adult
patients with relapsed or refractory CD30-positive HL following ASCT, or
following at least two prior therapies when ASCT or multi-agent
chemotherapy is not a treatment option, and (2) the treatment of adult
patients with relapsed or refractory sALCL. ADCETRIS has received
marketing authorization by regulatory authorities in 45 countries. See
important safety information below.
Seattle Genetics and Takeda
are jointly developing ADCETRIS. Under the terms of the collaboration
agreement, Seattle Genetics has U.S. and Canadian commercialization
rights and Takeda has rights to commercialize ADCETRIS in the rest of
the world. Seattle Genetics and Takeda are funding joint development
costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda will
be solely responsible for development costs.
ADCETRIS U.S. Important Safety Information
BOXED WARNING
Progressive
multifocal leukoencephalopathy (PML): JC virus infection resulting in
PML and death can occur in patients receiving ADCETRIS.
Contraindication:
Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity.
Warnings and Precautions:
Peripheral neuropathy: ADCETRIS treatment causes a peripheral
neuropathy that is predominantly sensory. Cases of peripheral motor
neuropathy have also been reported. ADCETRIS-induced peripheral
neuropathy is cumulative. Monitor patients for symptoms of neuropathy,
such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning
sensation, neuropathic pain or weakness and institute dose modifications
accordingly.
Infusion reactions: Infusion-related reactions,
including anaphylaxis, have occurred with ADCETRIS. Monitor patients
during infusion. If an infusion reaction occurs, interrupt the infusion
and institute appropriate medical management. If anaphylaxis occurs,
immediately and permanently discontinue the infusion and administer
appropriate medical therapy.
Hematologic toxicities: Grade 3 or 4
anemia, thrombocytopenia and prolonged (≥1 week) severe neutropenia can
occur with ADCETRIS. Febrile neutropenia has been reported with
ADCETRIS. Monitor complete blood counts prior to each dose of ADCETRIS
and consider more frequent monitoring for patients with Grade 3 or 4
neutropenia. Closely monitor patients for fever. If Grade 3 or 4
neutropenia develops, manage by G-CSF support, dose delays, reductions
or discontinuation.
Serious infections and opportunistic
infections: Infections such as pneumonia, bacteremia and sepsis/septic
shock (including fatal outcomes) have been reported in patients treated
with ADCETRIS. Closely monitor patients during treatment for the
emergence of possible bacterial, fungal or viral infections.
Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.
Progressive multifocal leukoencephalopathy (PML): JC virus infection
resulting in PML and death has been reported in ADCETRIS-treated
patients. In addition to ADCETRIS therapy, other possible contributory
factors include prior therapies and underlying disease that may cause
immunosuppression. Consider the diagnosis of PML in any patient
presenting with new-onset signs and symptoms of central nervous system
abnormalities. Evaluation of PML includes, but is not limited to,
consultation with a neurologist, brain MRI, and lumbar puncture or brain
biopsy. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if
PML is confirmed.
Stevens-Johnson syndrome (SJS): SJS has been
reported with ADCETRIS. If SJS occurs, discontinue ADCETRIS and
administer appropriate medical therapy.
Embryo-fetal toxicity: Fetal harm can occur. Advise pregnant women of the potential hazard to the fetus.
Adverse Reactions:
ADCETRIS
was studied as monotherapy in 160 patients in two Phase 2 trials.
Across both trials, the most common adverse reactions (≥20%), regardless
of causality, were neutropenia, peripheral sensory neuropathy, fatigue,
nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia,
rash, thrombocytopenia, cough and vomiting.
Drug Interactions:
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to MMAE.
Use in Specific Populations:
MMAE
exposure is increased in patients with hepatic impairment and severe
renal impairment. Closely monitor these patients for adverse reactions.
For
additional important safety information, including Boxed WARNING,
please see the full U.S. prescribing information for ADCETRIS at
www.seattlegenetics.com or www.ADCETRIS.com.
ADCETRIS Global Important Safety Information
ADCETRIS® is indicated for the treatment of adult patients with relapsed or refractory (r/r) CD30+ Hodgkin lymphoma (HL):
1. Following autologous stem cell transplant or
2. Following at least 2 prior therapies when autologous stem cell transplantation is not a treatment option
ADCETRIS
is indicated for the treatment of adult patients with relapsed or
refractory systemic anaplastic large cell lymphoma (sALCL).
ADCETRIS
is contraindicated for patients who are hypersensitive to ADCETRIS. In
addition, combined use of bleomycin and ADCETRIS causes pulmonary
toxicity, and is contraindicated.
ADCETRIS can cause serious side effects, including:
Progressive multifocal leukoencephalopathy (PML): John Cunningham virus
(JCV) reactivation resulting in PML and death has been reported in
patients treated with ADCETRIS. Patients should be closely monitored for
new or worsening neurological, cognitive, or behavioral signs or
symptoms, which may be suggestive of PML.
Pancreatitis: Acute
pancreatitis has been observed in patients treated with ADCETRIS. Fatal
outcomes have been reported. Patients should be closely monitored for
new or worsening abdominal pain.
Pulmonary Toxicity: Cases of
pulmonary toxicity have been reported in patients receiving ADCETRIS. In
the event of new or worsening pulmonary symptoms (e.g., cough,
dyspnoea), a prompt diagnostic evaluation should be performed.
Serious infections and opportunistic infections: Serious infections such
as pneumonia, staphylococcal bacteraemia, sepsis/septic shock
(including fatal outcomes), and herpes zoster, and opportunistic
infections such as Pneumocystis jiroveci pneumonia and oral candidiasis
have been reported in patients treated with ADCETRIS. Patients should be
carefully monitored during treatment for emergence of possible serious
and opportunistic infections.
Infusion-related reactions:
Immediate and delayed infusion-related reactions, as well as
anaphylaxis, have occurred with ADCETRIS. Patients should be carefully
monitored during and after an infusion.
Tumor lysis syndrome
(TLS): TLS has been reported with ADCETRIS. Patients with rapidly
proliferating tumor and high tumor burden are at risk of TLS and should
be monitored closely and managed according to best medical practice.
Peripheral neuropathy (PN): ADCETRIS treatment may cause PN that is
predominantly sensory. Cases of peripheral motor neuropathy have also
been reported. Patients should be monitored for symptoms of PN, such as
hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning
sensation, neuropathic pain, or weakness.
Hematological
toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged
(equal to or greater than one week) Grade 3 or Grade 4 neutropenia can
occur with ADCETRIS. Complete blood counts should be monitored prior to
administration of each dose.
Febrile neutropenia: Febrile
neutropenia has been reported. Patients should be monitored closely for
fever and managed according to best medical practice.
Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): SJS
and TEN have been reported. Fatal outcomes have been reported.
Hyperglycemia: Hyperglycemia has been reported during trials in patients
with an elevated body mass index (BMI) with or without a history of
diabetes mellitus. Any patient who experiences an event of hyperglycemia
should have their serum glucose closely monitored.
Renal and
hepatic impairment: There is limited experience in patients with renal
and hepatic impairment. Population pharmacokinetic analysis indicated
that MMAE clearance might be affected by moderate and severe renal
impairment, and by low serum albumin concentrations. Elevations in
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have
been reported. Liver function should be routinely monitored in patients
receiving brentuximab vedotin.
Sodium content in excipients:
This medicinal product contains a maximum of 2.1 mmol (or 47mg) of
sodium per dose. To be taken into consideration for patients on a
controlled sodium diet.
Serious adverse drug reactions were:
neutropenia, thrombocytopenia, constipation, diarrhea, vomiting,
pyrexia, peripheral motor neuropathy and peripheral sensory neuropathy,
hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and
Stevens-Johnson syndrome.
ADCETRIS was studied as monotherapy in
160 patients in two Phase 2 studies. Across both studies, adverse
reactions defined as very common (≥1/10) were: infections, neutropenia,
peripheral sensory neuropathy, diarrhea, nausea, vomiting, alopecia,
pruritis, myalgia, fatigue, pyrexia, and infusion-related reactions.
Adverse reactions defined as common (≥1/100 to <1/10) were: upper
respiratory tract infection, herpes zoster, pneumonia, anemia,
thrombocytopenia, hyperglycemia, peripheral motor neuropathy, dizziness,
demyelinating polyneuropathy, cough, dyspnea, constipation, rash,
arthralgia, back pain, and chills.
These are not all of the
possible side effects with ADCETRIS. Please refer to Summary of Product
Characteristics (SmPC) before prescribing.
About Ixazomib
Ixazomib
is an investigational oral, proteasome inhibitor, which is being
studied in multiple myeloma and other malignancies. It is the first oral
proteasome inhibitor to enter Phase 3 clinical trials. Four global
Phase 3 trials are ongoing; TOURMALINE-MM1, investigating ixazomib in
combination with lenalidomide and dexamethasone in relapsed and/or
refractory MM, TOURMALINE-MM2, investigating ixazomib in combination
with lenalidomide and dexamethasone in patients with newly diagnosed MM,
TOURMALINE-MM3, investigating ixazomib as maintenance therapy in
patients with newly diagnosed MM following induction therapy and
autologous stem cell transplant and TOURMALINE-AL1, investigating
ixazomib plus dexamethasone in patients with relapsed or refractory
light chain amyloidosis (AL). For additional information on the ongoing
Phase 3 studies please visit www.tourmalinetrials.com or
www.clinicaltrials.gov.
About Takeda Pharmaceutical Company Limited
Located
in Osaka, Japan, Takeda is a research-based global company with its
main focus on pharmaceuticals. As the largest pharmaceutical company in
Japan and one of the global leaders of the industry, Takeda is committed
to strive towards better health for people worldwide through leading
innovation in medicine. Additional information about Takeda is available
through its corporate website, www.takeda.com.
Contacts
Takeda Pharmaceutical Company Limited
Elizabeth Pingpank, +1-617-444-1495
elizabeth.pingpank@takeda.com
or
Corporate Communications Dept. (PR/IR),
+81-3-3278-2037
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