-ADCETRIS
in Combination with Chemotherapy Achieved Primary Endpoint,
Demonstrating a Statistically Significant Improvement in
Progression-Free Survival Compared to a Standard of Care Chemotherapy-
-Statistically Significant Improvement Achieved in All Key Secondary Endpoints, Including Overall Survival-
-First Randomized Phase 3 Trial to Show Improvement in Overall Survival in Frontline Peripheral T-Cell Lymphoma-
-Data to be Presented at the 2018 ASH Annual Meeting; Global Regulatory Submissions Planned-
BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan-Thursday 4 October 2018 [ AETOS Wire ]
(BUSINESS
WIRE) -- Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical
Company Limited (TSE:4502) announced today that the phase 3 ECHELON-2
clinical trial met its primary endpoint. The trial demonstrated a
statistically significant improvement in progression-free survival (PFS)
of ADCETRIS (brentuximab vedotin) in combination with CHP
(cyclophosphamide, doxorubicin, prednisone) versus the control arm, CHOP
(cyclophosphamide, doxorubicin, vincristine, prednisone). ECHELON-2 is a
global, randomized, double-blind, multicenter trial evaluating ADCETRIS
as part of a frontline combination chemotherapy regimen in patients
with previously untreated CD30-expressing peripheral T-cell lymphoma
(PTCL), also known as mature T-cell lymphoma (MTCL). ADCETRIS is an
antibody-drug conjugate (ADC) directed to CD30, which is expressed on
the surface of several types of PTCL. ADCETRIS is currently not approved
for the frontline treatment of PTCL.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181001005282/en/
Patients
in ECHELON-2 were randomized to receive either a combination of
ADCETRIS plus CHP or CHOP, a recognized standard of care for frontline
PTCL. Results from the trial demonstrated that combination treatment
with ADCETRIS plus CHP was superior to the control arm for PFS as
assessed by an Independent Review Facility (IRF; hazard ratio=0.71;
p-value=0.0110). The ADCETRIS plus CHP arm also demonstrated superior
overall survival (OS), a key secondary endpoint, compared to CHOP
(hazard ratio=0.66; p-value=0.0244). All other key secondary endpoints,
including PFS in patients with systemic anaplastic large cell lymphoma
(sALCL), complete remission rate and objective response rate were
statistically significant in favor of the ADCETRIS plus CHP arm. The
safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was
comparable to CHOP and consistent with the established safety profile of
ADCETRIS in combination with chemotherapy. Additional data will be
presented at the American Society of Hematology (ASH) 2018 annual
meeting, December 1-4, 2018, in San Diego, California.
“Peripheral
T-cell lymphoma is an aggressive type of non-Hodgkin lymphoma with
approximately 4,000 CD30-expressing patients diagnosed every year in the
United States,” said Clay Siegall, Ph.D., President and Chief Executive
Officer of Seattle Genetics. “We are excited about the groundbreaking
results of the phase 3 ECHELON-2 clinical trial, which demonstrated
ADCETRIS in combination with chemotherapy significantly improved
treatment outcomes for adult patients with previously untreated
CD30-expressing PTCL compared with the current standard of care (CHOP).
We’d like to thank the many investigators and patients who participated
in this study and contributed to this significant milestone for the PTCL
community. We look forward to presenting results at the ASH annual
meeting in December and intend to submit a supplemental Biologics
License Application to the FDA for approval in this setting in the near
future.”
“These
clinically meaningful results from ECHELON-2 represent a significant
step in the development of a potential frontline treatment in this
disease. This trial is the largest randomized, double-blind, phase 3
trial in PTCL,” said Jesús Gomez-Navarro, M.D., Vice President, Head of
Oncology Clinical Research and Development, Takeda. “Standard of care in
PTCL has not changed in several decades and there remains an unmet need
for patients. These data showed a significant improvement in the
primary endpoint of progression-free survival and all key secondary
endpoints, including overall survival, along with a manageable safety
profile. We look forward to sharing these data with regulatory
authorities globally.”
Takeda and Seattle Genetics plan to submit these results to regulatory authorities for approval in their respective territories.
ECHELON-2 Phase 3 Clinical Trial Design
The
randomized, double-blind, placebo-controlled phase 3 trial is
investigating ADCETRIS plus CHP (cyclophosphamide, doxorubicin,
prednisone) versus CHOP (cyclophosphamide, doxorubicin, vincristine,
prednisone) as frontline therapy in patients with CD30-expressing
peripheral T-cell lymphoma, also known as mature T-cell lymphoma. The
primary endpoint is progression-free survival (PFS) per Independent
Review Facility assessment, with events defined as progression, death,
or receipt of chemotherapy for residual or progressive disease.
Secondary endpoints include PFS in patients with systemic anaplastic
large cell lymphoma (sALCL), complete remission rate, overall survival
and objective response rate, in addition to safety. The multi-center
trial was conducted at sites across North America, Europe and Asia and
was designed to enroll 450 patients, approximately 75 percent of whom
were to be diagnosed with sALCL. The ECHELON-2 trial is being conducted
under a Special Protocol Assessment (SPA) agreement from the U.S. Food
and Drug Administration (FDA) and the trial also received European
Medicines Agency (EMA) scientific advice.
Please see Important Safety Information at the end of this press release.
About T-Cell Lymphomas
Lymphoma
is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. There are more than 60 subtypes of
non-Hodgkin lymphomas which are broadly divided into two major groups:
B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell
lymphomas, which develop from abnormal T-lymphocytes. There are many
different forms of T-cell lymphomas, some of which are extremely rare.
T-cell lymphomas can be aggressive (fast-growing) or indolent
(slow-growing). PTCL, also known as MTCL, accounts for approximately 10
percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be
as high as 24 percent in parts of Asia.
About ADCETRIS (brentuximab vedotin)
ADCETRIS
is being evaluated broadly in more than 70 clinical trials, including
the completed phase 3 ECHELON-2 trial in frontline peripheral T-cell
lymphomas (also known as mature T-cell lymphoma), the completed phase 3
ALCANZA trial in cutaneous T-cell lymphoma (CTCL) and the completed
ECHELON-1 trial in previously untreated Hodgkin lymphoma, as well as
trials in many additional types of CD30-expressing malignancies.
ADCETRIS
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
injection for intravenous infusion has received FDA approval for five
indications in adult patients with: (1) previously untreated Stage III
or IV classical Hodgkin lymphoma (cHL), in combination with
chemotherapy, (2) cHL at high risk of relapse or progression as
post-autologous hematopoietic stem cell transplantation (auto-HSCT)
consolidation, (3) cHL after failure of auto-HSCT or failure of at least
two prior multi-agent chemotherapy regimens in patients who are not
auto-HSCT candidates, (4) sALCL after failure of at least one prior
multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic
large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)
who have received prior systemic therapy.
Health
Canada granted ADCETRIS approval with conditions for relapsed or
refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional
approval for post-autologous stem cell transplantation (ASCT)
consolidation treatment of Hodgkin lymphoma patients at increased risk
of relapse or progression.
ADCETRIS
received conditional marketing authorization from the European
Commission in October 2012. The approved indications in Europe are: (1)
for the treatment of adult patients with relapsed or refractory
CD30-positive Hodgkin lymphoma following ASCT, or following at least two
prior therapies when ASCT or multi-agent chemotherapy is not a
treatment option, (2) the treatment of adult patients with relapsed or
refractory sALCL, (3) for the treatment of adult patients with
CD30-positive Hodgkin lymphoma at increased risk of relapse or
progression following ASCT, and (4) for the treatment of adult patients
with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one
prior systemic therapy.
ADCETRIS
has received marketing authorization by regulatory authorities in 71
countries for relapsed or refractory Hodgkin lymphoma and sALCL. See
select important safety information, including Boxed Warning, 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 is solely responsible for development costs.
About Seattle Genetics
Seattle
Genetics, Inc. is an emerging multi-product, global biotechnology
company that develops and commercializes transformative therapies
targeting cancer to make a meaningful difference in people’s lives.
ADCETRIS® (brentuximab vedotin) utilizes the company’s industry-leading
antibody-drug conjugate (ADC) technology and is currently approved for
the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS,
the company has established a pipeline of novel targeted therapies at
various stages of clinical testing, including three in ongoing pivotal
trials for solid tumors. Enfortumab vedotin for metastatic urothelial
cancer and tisotumab vedotin for metastatic cervical cancer utilize our
proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase
inhibitor, is in a pivotal trial for HER2-positive metastatic breast
cancer. In addition, we are leveraging our expertise in empowered
antibodies to build a portfolio of proprietary immuno-oncology agents in
clinical trials targeting hematologic malignancies and solid tumors.
The company is headquartered in Bothell, Washington, and has a European
office in Switzerland. For more information on our robust pipeline,
visit www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
About Takeda Pharmaceutical Company
Takeda
Pharmaceutical Company Limited (TSE: 4502) is a global, research and
development-driven pharmaceutical company committed to bringing better
health and a brighter future to patients by translating science into
life-changing medicines. Takeda focuses its R&D efforts on
oncology, gastroenterology and neuroscience therapeutic areas plus
vaccines. Takeda conducts R&D both internally and with partners
to stay at the leading edge of innovation. Innovative products,
especially in oncology and gastroenterology, as well as Takeda’s
presence in emerging markets, are currently fueling the growth of
Takeda. Approximately 30,000 Takeda employees are committed to improving
quality of life for patients, working with Takeda’s partners in health
care in more than 70 countries.
For more information, visit https://www.takeda.com/newsroom/.
Additional
information about Takeda is available through its corporate website,
www.takeda.com, and additional information about Takeda Oncology, the
brand for the global oncology business unit of Takeda Pharmaceutical
Company Limited, is available through its website,
www.takedaoncology.com.
ADCETRIS (brentuximab vedotin) U.S. Select Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):
JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
Contraindication
ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
Peripheral
neuropathy (PN): ADCETRIS causes PN that is predominantly sensory.
Cases of motor PN have also been reported. ADCETRIS-induced PN is
cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia,
paresthesia, discomfort, a burning sensation, neuropathic pain, or
weakness. Institute dose modifications accordingly.
Anaphylaxis
and infusion reactions: Infusion-related reactions (IRR), including
anaphylaxis, have occurred with ADCETRIS. Monitor patients during
infusion. If an IRR occurs, interrupt the infusion and institute
appropriate medical management. If anaphylaxis occurs, immediately and
permanently discontinue the infusion and administer appropriate medical
therapy. Premedicate patients with a prior IRR before subsequent
infusions. Premedication may include acetaminophen, an antihistamine,
and a corticosteroid.
Hematologic
toxicities: Fatal and serious cases of febrile neutropenia have been
reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade
3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Administer
G-CSF primary prophylaxis starting with Cycle 1 for previously untreated
patients who receive ADCETRIS in combination with chemotherapy for
Stage III or IV HL. Monitor complete blood counts prior to each ADCETRIS
dose. Consider more frequent monitoring for patients with Grade 3 or 4
neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia
develops, consider dose delays, reductions, discontinuation, or G-CSF
prophylaxis with subsequent doses.
Serious
infections and opportunistic infections: Infections such as pneumonia,
bacteremia, and sepsis or septic shock (including fatal outcomes) have
been reported in ADCETRIS-treated patients. Closely monitor patients
during treatment for bacterial, fungal, or viral infections.
Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.
Increased
toxicity in the presence of severe renal impairment: The frequency of
≥Grade 3 adverse reactions and deaths was greater in patients with
severe renal impairment compared to patients with normal renal function.
Avoid use in patients with severe renal impairment.
Increased
toxicity in the presence of moderate or severe hepatic impairment: The
frequency of ≥Grade 3 adverse reactions and deaths was greater in
patients with moderate or severe hepatic impairment compared to patients
with normal hepatic function. Avoid use in patients with moderate or
severe hepatic impairment.
Hepatotoxicity:
Fatal and serious cases have occurred in ADCETRIS-treated patients.
Cases were consistent with hepatocellular injury, including elevations
of transaminases and/or bilirubin, and occurred after the first ADCETRIS
dose or rechallenge. Preexisting liver disease, elevated baseline liver
enzymes, and concomitant medications may increase the risk. Monitor
liver enzymes and bilirubin. Patients with new, worsening, or recurrent
hepatotoxicity may require a delay, change in dose, or discontinuation
of ADCETRIS.
PML:
Fatal cases of JC virus infection resulting in PML and death have been
reported in ADCETRIS-treated patients. First onset of symptoms occurred
at various times from initiation of ADCETRIS therapy, with some cases
occurring within 3 months of initial exposure. Other possible
contributory factors other than ADCETRIS include prior therapies and
underlying disease that may cause immunosuppression. Consider PML
diagnosis in patients with new-onset signs and symptoms of central
nervous system abnormalities. Hold ADCETRIS if PML is suspected and
discontinue ADCETRIS if PML is confirmed.
Pulmonary
toxicity: Fatal and serious events of noninfectious pulmonary toxicity
including pneumonitis, interstitial lung disease, and acute respiratory
distress syndrome have been reported. Monitor patients for signs and
symptoms, including cough and dyspnea. In the event of new or worsening
pulmonary symptoms, hold ADCETRIS dosing during evaluation and until
symptomatic improvement.
Serious
dermatologic reactions: Fatal and serious cases of Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported
with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer
appropriate medical therapy.
Gastrointestinal
(GI) complications: Fatal and serious cases of acute pancreatitis have
been reported. Other fatal and serious GI complications include
perforation, hemorrhage, erosion, ulcer, intestinal obstruction,
enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting
GI involvement may increase the risk of perforation. In the event of
new or worsening GI symptoms, perform a prompt diagnostic evaluation and
treat appropriately.
Embryo-fetal
toxicity: Based on the mechanism of action and animal studies, ADCETRIS
can cause fetal harm. Advise females of reproductive potential of the
potential risk to the fetus, and to avoid pregnancy during ADCETRIS
treatment and for at least 6 months after the final dose of ADCETRIS.
Most
Common (≥20%) Adverse Reactions: Neutropenia, anemia, peripheral
sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting,
and pyrexia.
Drug Interactions
Concomitant
use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has
the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.
Advise
males with female sexual partners of reproductive potential to use
effective contraception during ADCETRIS treatment and for at least 6
months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
For
additional Important Safety Information, including BOXED WARNING,
please see the full Prescribing Information for ADCETRIS at
www.seattlegenetics.com or http://www.ADCETRIS.com.
ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
CONTRAINDICATIONS
ADCETRIS
is contraindicated for patients with hypersensitivity to brentuximab
vedotin and its excipients. In addition, combined use of ADCETRIS with
bleomycin causes pulmonary toxicity.
SPECIAL WARNINGS & PRECAUTIONS
Progressive
multifocal leukoencephalopathy (PML): John Cunningham virus (JCV)
reactivation resulting in progressive multifocal leukoencephalopathy
(PML) and death can occur in patients treated with ADCETRIS. PML has
been reported in patients who received ADCETRIS after receiving multiple
prior chemotherapy regimens. PML is a rare demyelinating disease of the
central nervous system that results from reactivation of latent JCV and
is often fatal.
Closely
monitor patients for new or worsening neurological, cognitive, or
behavioral signs or symptoms, which may be suggestive of PML. Suggested
evaluation of PML includes neurology consultation, gadolinium-enhanced
magnetic resonance imaging of the brain, and cerebrospinal fluid
analysis for JCV DNA by polymerase chain reaction or a brain biopsy with
evidence of JCV. A negative JCV PCR does not exclude PML. Additional
follow up and evaluation may be warranted if no alternative diagnosis
can be established Hold dosing for any suspected case of PML and
permanently discontinue ADCETRIS if a diagnosis of PML is confirmed. Be
alert to PML symptoms that the patient may not notice (e.g., cognitive,
neurological, or psychiatric symptoms).
Pancreatitis:
Acute pancreatitis has been observed in patients treated with ADCETRIS.
Fatal outcomes have been reported. Closely monitor patients for new or
worsening abdominal pain, which may be suggestive of acute pancreatitis.
Patient evaluation may include physical examination, laboratory
evaluation for serum amylase and serum lipase, and abdominal imaging,
such as ultrasound and other appropriate diagnostic measures. Hold
ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should
be discontinued if a diagnosis of acute pancreatitis is confirmed.
Pulmonary
Toxicity: Cases of pulmonary toxicity, some with fatal outcomes,
including pneumonitis, interstitial lung disease, and acute respiratory
distress syndrome (ARDS), have been reported in patients receiving
ADCETRIS. Although a causal association with ADCETRIS has not been
established, the risk of pulmonary toxicity cannot be ruled out.
Promptly evaluate and treat new or worsening pulmonary symptoms
appropriately. Consider holding dosing during evaluation and until
symptomatic improvement.
Serious
infections and opportunistic infections: Serious infections such as
pneumonia, staphylococcal bacteremia, 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. Carefully monitor patients during
treatment for emergence of possible serious and opportunistic
infections.
Infusion-related
reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis,
have occurred with ADCETRIS. Carefully monitor patients during and after
an infusion. If anaphylaxis occurs, immediately and permanently
discontinue administration of ADCETRIS Appropriate medical therapy
should be administered. If an IRR occurs, interrupt the infusion and
institute appropriate medical management. The infusion may be restarted
at a slower rate after symptom resolution. Patients who have experienced
a prior IRR should be premedicated for subsequent infusions. IRRs are
more frequent and more severe in patients with antibodies to ADCETRIS.
Tumor
lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients
with rapidly proliferating tumor and high tumor burden are at risk of
TLS. Monitor these patients closely and managed according to best
medical practice.
Peripheral
neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and
motor. ADCETRIS-induced PN is typically cumulative and reversible in
most cases. Monitor patients for symptoms of PN, such as hypoesthesia,
hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic
pain, or weakness. Patients experiencing new or worsening PN may
require a delay and a dose reduction or discontinuation of ADCETRIS.
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. Monitor complete blood counts prior to
administration of each dose.
Febrile
neutropenia: Febrile neutropenia has been reported. Closely monitor
patients for fever and manage according to best medical practice if
febrile neutropenia develops.
Stevens-Johnson
syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been
reported with ADCETRIS. Fatal outcomes have been reported. Discontinue
treatment with ADCETRIS if SJS or TEN occurs and administer appropriate
medical therapy.
Gastrointestinal
(GI) Complications: GI complications, some with fatal outcomes,
including intestinal obstruction, ileus, enterocolitis, neutropenic
colitis, erosion, ulcer, perforation and haemorraghe, have been
reported. Promptly evaluate and treat patients if new or worsening GI
symptoms occur.
Hepatotoxicity:
Elevations in alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) have been reported. Serious cases of
hepatotoxicity, including fatal outcomes, have also occurred. Test liver
function prior to treatment initiation and routinely monitor patients
receiving ADCETRIS for liver elevations. Patients experiencing
hepatotoxicity may require a delay, dose modification, or
discontinuation of ADCETRIS.
Hyperglycemia:
Hyperglycemia has been reported during trials in patients with an
elevated body mass index (BMI) with or without a history of diabetes
mellitus. Closely monitor serum glucose for patients who experiences an
event of hyperglycemia. Administer anti-diabetic treatment as
appropriate.
Renal
and Hepatic Impairment: There is limited experience in patients with
renal and hepatic impairment. Available data indicate that MMAE
clearance might be affected by severe renal impairment, hepatic
impairment, and by low serum albumin concentrations.
CD30+
CTCL: The size of the treatment effect in CD30 + CTCL subtypes other
than mycosis fungoides (MF) and primary cutaneous anaplastic large cell
lymphoma (pcALCL) is not clear due to lack of high level evidence. In
two single arm phase II studies of ADCETRIS, disease activity has been
shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP)
and mixed CTCL histology. These data suggest that efficacy and safety
can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the
benefit-risk per patient and use caution in other CD30+ CTCL patient
types.
Sodium
content in excipients: ADCETRIS contains a maximum of 2.1 mmol (or 47
mg) of sodium per dose. Take this into consideration for patients on a
controlled sodium diet.
INTERACTIONS
Patients
who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly
with ADCETRIS may have an increased risk of neutropenia and should be
closely monitored. Co-administration of ADCETRIS with a CYP3A4 inducer
did not alter the plasma exposure of ADCETRIS but it appeared to reduce
plasma concentrations of MMAE metabolites that could be assayed.
ADCETRIS is not expected to alter the exposure to drugs that are
metabolized by CYP3A4 enzymes.
PREGNANCY:
Advise women of childbearing potential to use two methods of effective
contraception during treatment with ADCETRIS and until 6 months after
treatment. There are no data from the use of ADCETRIS in pregnant women,
although studies in animals have shown reproductive toxicity. Do not
use ADCETRIS during pregnancy unless the benefit to the mother outweighs
the potential risks to the fetus.
LACTATION
(breast-feeding): There are no data as to whether ADCETRIS or its
metabolites are excreted in human milk, therefore a risk to the
newborn/infant cannot be excluded. With the potential risk, a decision
should be made whether to discontinue breast-feeding or
discontinue/abstain from therapy with ADCETRIS.
FERTILITY:
In nonclinical studies, ADCETRIS treatment has resulted in testicular
toxicity, and may alter male fertility. Advise men being treated with
ADCETRIS not to father a child during treatment and for up to 6 months
following the last dose.
Effects on ability to drive and use machines: ADCETRIS may have a minor influence on the ability to drive and use machines.
UNDESIRABLE EFFECTS
The
most frequent adverse reactions (≥10%) were infections, peripheral
sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper
respiratory tract infection, neutropenia, rash, cough, vomiting,
arthralgia, peripheral motor neuropathy, infusion-related reactions,
pruritus, constipation, dyspnoea, weight decreased, myalgia and
abdominal pain.
Serious
adverse drug reactions were: pneumonia, acute respiratory distress
syndrome, headache, neutropenia, thrombocytopenia, constipation,
diarrhea, vomiting, nausea, pyrexia, peripheral motor neuropathy,
peripheral sensory neuropathy, hyperglycemia, demyelinating
polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome.
Serious adverse drug reactions occurred in 12% of patients. The
frequency of unique serious adverse drug reactions was ≤1%.
Forward-Looking Statements for Seattle Genetics
Certain
of the statements made in this press release are forward looking, such
as those, among others, relating to the therapeutic potential of
ADCETRIS (brentuximab vedotin) as a potential treatment in frontline
peripheral T-cell lymphoma, anticipated presentation of data from
ECHELON-2 at ASH in 2018 and plans and timing for submission for
supplemental regulatory approval to and obtaining regulatory approval
from the FDA and other regulatory authorities. Actual results or
developments may differ materially from those projected or implied in
these forward-looking statements. Factors that may cause such a
difference include that the safety and/or efficacy results of the
ECHELON-2 trial in peripheral T-cell lymphoma will not be presented as
anticipated or sufficient to gain marketing approval in the United
States or any other country, that we will be required to amend our
submission for marketing approval or that such submission will be
refused or delayed. In addition, our regulatory plans may change as a
result of consultation with the FDA or other regulatory authorities.
More information about the risks and uncertainties faced by Seattle
Genetics is contained under the caption “Risk Factors” included in the
company’s Quarterly Report on Form 10-Q for the quarter ended June 30,
2018 filed with the Securities and Exchange Commission. Seattle Genetics
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181001005282/en/
Contacts
Seattle Genetics
Investors:
Peggy Pinkston, +1-425-527-4160
ppinkston@seagen.com
or
Media:
Tricia Larson, +1-425-527-4180
tlarson@seagen.com
or
Takeda Pharmaceutical Company Limited
Media:
Japanese Media
Kazumi Kobayashi, +81 (0) 3-3278-2095
kazumi.kobayashi@takeda.com
or
Media outside Japan
Sara Noonan, +1-617-551-3683
sara.noonan@takeda.com
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