-Randomized Phase 3 Clinical Trial with
ADCETRIS Met Primary Endpoint, Demonstrating a Statistically
Significant Improvement in Modified Progression-Free Survival-
-Abstract to be Submitted for Presentation at
the 2017 ASH Annual Meeting; Regulatory Submissions Planned-
-Seattle Genetics to Host Conference Call and
Webcast Today at 8:30 a.m. ET-
Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle
Genetics, Inc. (NASDAQ: SGEN) today announced that the Phase 3
ECHELON-1 clinical trial met its primary endpoint of a
statistically significant improvement in modified progression-free
survival (PFS) versus the control arm. ECHELON-1 is a randomized,
multicenter trial evaluating ADCETRIS (brentuximab vedotin) as part
of a frontline combination chemotherapy regimen in 1,334 patients
with previously untreated advanced classical Hodgkin lymphoma.
ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a
defining marker of classical Hodgkin lymphoma. ADCETRIS is
currently not approved as a frontline therapy for Hodgkin
lymphoma.
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Patients in ECHELON-1 were randomized to receive either a
combination of ADCETRIS+AVD (Adriamycin, vinblastine, dacarbazine)
or ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), a
recognized standard of care for frontline Hodgkin lymphoma. The
results of the ECHELON-1 trial demonstrated that combination
treatment with ADCETRIS resulted in a statistically significant
improvement in modified PFS versus the control arm as assessed by
an Independent Review Facility (hazard ratio=0.770; p-value=0.035).
The two-year modified PFS rate for patients in the ADCETRIS arm was
82.1 percent compared to 77.2 percent in the control arm. Interim
analysis of overall survival (OS), the key secondary endpoint, also
trended in favor of the ADCETRIS+AVD arm. An abstract will be
submitted for data presentation at the American Society of
Hematology (ASH) annual meeting, December 9-12, 2017, in Atlanta,
Ga.
The safety profile of ADCETRIS+AVD in the ECHELON-1 trial was
consistent with that known for the single-agent components of the
regimen. There was an increased incidence of febrile neutropenia
and peripheral neuropathy in the ADCETRIS+AVD arm. Febrile
neutropenia was reduced through the use of prophylactic growth
factors in a subset of patients, and peripheral neuropathy was
managed through dose modifications. The control arm had an
increased rate and severity of pulmonary toxicity.
“We are excited about the positive result which shows a
statistically significant improvement in the primary endpoint of
modified PFS,” said Dirk Huebner, M.D., Executive Medical Director,
Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “The
results of this trial signify an important step forward in the
development of ADCETRIS and have the potential to change the
treatment approach of frontline advanced Hodgkin lymphoma.”
“The outcome of the Phase 3 ECHELON-1 trial represents a
significant milestone for the Hodgkin lymphoma community,” said
Clay Siegall, Ph.D., President and Chief Executive Officer of
Seattle Genetics. “Seattle Genetics’ goal is to establish ADCETRIS
as the foundation of care for CD30-expressing lymphomas, including
Hodgkin lymphoma. Notably, this is the first clinical trial in
frontline advanced Hodgkin lymphoma to show superior efficacy of a
regimen that eliminates bleomycin.”
Takeda and Seattle Genetics plan to submit these results to
regulatory authorities for approval in their respective
territories.
ECHELON-1 Phase 3 Clinical Trial Design
The randomized, open-label, Phase 3 trial is investigating
ADCETRIS+AVD versus ABVD as frontline therapy in patients with
advanced classical Hodgkin lymphoma. The primary endpoint is
modified progression-free survival per Independent Review Facility
assessment using the Revised Response Criteria for Malignant
Lymphoma. Modified PFS is defined as the time to progression, death
or receipt of additional anticancer therapy for patients who are
not in complete response after completion of frontline therapy per
Independent Review Facility. This endpoint was chosen as it
provides a clearer picture of the efficacy of frontline
chemotherapy and eliminates the confounding impact of salvage and
consolidation chemotherapies and radiotherapy. Secondary endpoints
include overall survival, complete remission and safety. The
multi-center trial was conducted in North America, Europe, South
America, Australia, Asia and Africa. The study enrolled 1,334
patients who had a histologically-confirmed diagnosis of Stage III
or IV classical Hodgkin lymphoma and had not been previously
treated with systemic chemotherapy or radiotherapy. The ECHELON-1
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.
Seattle Genetics Conference Call Details
Seattle Genetics' management will host a conference call and
webcast to discuss this announcement. The event will be held today
at 5:30 a.m. Pacific Time (PT) / 8:30 a.m. Eastern Time (ET). The
live event will be available from Seattle Genetics' website at
http://www.seattlegenetics.com, under the Investors section, or by
calling 877-723-9521 (domestic) or 719-325-2138 (international).
The access code is 9916080. A replay of the discussion will be
available beginning at approximately 8:30 a.m. PT / 11:30 a.m. ET
today from Seattle Genetics' website or by calling 888-203-1112
(domestic) or 719-457-0820 (international), using access code
9916080. The telephone replay will be available until 5:00 p.m. PT
/ 8:00 p.m. ET Wednesday, June 28, 2017.
About Classical Hodgkin Lymphoma
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. Classical
Hodgkin lymphoma is distinguished from other types of lymphoma by
the presence of one characteristic type of cell, known as the
Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.
About ADCETRIS
ADCETRIS is being evaluated broadly in more than 70 clinical
trials in CD30-expressing lymphomas, including three Phase 3
studies: the completed ECHELON-1 trial in frontline classical
Hodgkin lymphoma, the completed ALCANZA trial in cutaneous T-cell
lymphoma, and the ongoing ECHELON-2 trial in frontline mature
T-cell lymphomas.
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 for intravenous injection has received approval from
the FDA for three indications: (1) regular approval for the
treatment of patients with classical Hodgkin lymphoma after failure
of autologous hematopoietic stem cell transplantation (auto-HSCT)
or after failure of at least two prior multi-agent chemotherapy
regimens in patients who are not auto-HSCT candidates, (2) regular
approval for the treatment of classical Hodgkin lymphoma patients
at high risk of relapse or progression as post-auto-HSCT
consolidation, and (3) accelerated approval for the treatment of
patients with systemic anaplastic large cell lymphoma (sALCL) after
failure of at least one prior multi-agent chemotherapy regimen. The
sALCL indication is approved under accelerated approval based on
overall response rate. Continued approval for the sALCL indication
may be contingent upon verification and description of clinical
benefit in confirmatory trials. Health Canada granted ADCETRIS
approval with conditions for relapsed or refractory Hodgkin
lymphoma and sALCL.
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 Hodgkin lymphoma following autologous stem cell
transplant (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.
In June 2016, the European Commission extended the current
conditional approval of ADCETRIS and approved ADCETRIS for the
treatment of adult patients with CD30-positive Hodgkin lymphoma at
increased risk of relapse or progression following ASCT.
ADCETRIS has received marketing authorization by regulatory
authorities in 67 countries for relapsed or refractory Hodgkin
lymphoma and sALCL. 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 is solely
responsible for development costs.
ADCETRIS (brentuximab vedotin) Global Important Safety
Information
CONTRAINDICATIONS
ADCETRIS is contraindicated for patients with hypersensitivity
to brentuximab vedotin and its excipients. In addition, combined
use of ADCETRIS with bleomycin is contraindicated as it causes
pulmonary toxicity.
SPECIAL WARNINGS & PRECAUTIONS
Progressive multifocal leukoencephalopathy (PML): John
Cunningham virus (JCV) reactivation resulting in 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.
Patients should be closely monitored 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. ADCETRIS dosing should be held for any suspected case of PML
and should be permanently discontinued if a diagnosis of PML is
confirmed.
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, 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. ADCETRIS
should be held 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, 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.
New or worsening pulmonary symptoms should be promptly evaluated
and treated appropriately.
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. Patients should be carefully monitored
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. Patients
should be carefully monitored during and after an infusion. If
anaphylaxis occurs, administration of ADCETRIS should be
immediately and permanently discontinued and appropriate medical
therapy should be administered. If an IRR occurs, the infusion
should be interrupted and appropriate medical management
instituted. 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. These patients should be monitored
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. Patients should be
monitored 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. 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 if febrile neutropenia
develops.
Stevens-Johnson syndrome (SJS): SJS and toxic epidermal
necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes
have been reported. If SJS or TEN occurs, treatment with ADCETRIS
should be discontinued and appropriate medical therapy should be
administered.
Gastrointestinal (GI) Complications: GI complications,
some with fatal outcomes, including intestinal obstruction, ileus,
enterocolitis, neutropenic colitis, erosion, ulcer, perforation and
haemorragh, have been reported. New or worsening GI symptoms should
be promptly evaluated and treated appropriately.
Hepatotoxicity: Elevations in alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) have been reported.
Serious cases of hepatotoxicity, including fatal outcomes, have
also occurred. Liver function should be tested prior to treatment
initiation and routinely monitored in patients receiving ADCETRIS.
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. However, any patient who
experiences an event of hyperglycemia should have their serum
glucose closely monitored. Anti-diabetic treatment should be
administered 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. The recommended starting dose in patients with
hepatic impairment or severe renal impairment is 1.2 mg/kg
administered as an intravenous infusion over 30 minutes every 3
weeks. Patients with renal or hepatic impairment should be closely
monitored for adverse events.
Sodium content in excipients: This medicinal product
contains a maximum of 2.1 mmol (or 47 mg) of sodium per dose. To be
taken 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: Women of childbearing potential should be
using 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. ADCETRIS should not be used
during pregnancy unless the benefit to the mother outweighs the
potential risks to the fetus. If a pregnant woman needs to be
treated, she should be clearly advised on the potential risk 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. Men
being treated with this medicine are advised not to father a child
during treatment and for up to 6 months following the last
dose.
ADVERSE REACTIONS
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.
In the clinical studies of ADCETRIS, adverse reactions defined
as very common (≥1/10) were: infection, upper respiratory tract
infection, neutropenia, PN (sensory and motor), cough, dyspneoa,
diarrhea, nausea, vomiting, constipation, abdominal pain, alopecia,
pruritus, myalgia, arthralgia, fatigue, chills, pyrexia,
infusion-related reactions and weight decreased. Adverse reactions
defined as common (≥1/100 to <1/10) were: Sepsis/septic shock,
herpes zoster, pneumonia, herpes simplex, anemia, thrombocytopenia,
hyperglycemia, dizziness, demyelinating polyneuropathy, ALT/AST
increased, rash, and back pain.
ADCETRIS (brentuximab vedotin) 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
ADCETRIS is contraindicated with concomitant bleomycin due to
pulmonary toxicity (e.g., interstitial infiltration and/or
inflammation).
Warnings and Precautions
- Peripheral neuropathy (PN): ADCETRIS
treatment causes a PN that is predominantly sensory. Cases of motor
PN have also been reported. ADCETRIS-induced PN 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.
- Anaphylaxis and infusion reactions:
Infusion-related reactions, including anaphylaxis, have occurred
with ADCETRIS. Monitor patients during infusion. If an
infusion-related reaction occurs, interrupt the infusion and
institute appropriate medical management. If anaphylaxis occurs,
immediately and permanently discontinue the infusion and administer
appropriate medical therapy. Patients who experienced a prior
infusion-related reaction should be premedicated for subsequent
infusions. Premedication may include acetaminophen, an
antihistamine, and a corticosteroid.
- Hematologic toxicities: Prolonged (≥1
week) severe neutropenia and Grade 3 or 4 thrombocytopenia or
anemia 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. 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
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.
- 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
the use of ADCETRIS 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 the use of ADCETRIS in patients with
moderate or severe hepatic impairment.
- Hepatotoxicity: Serious cases of
hepatotoxicity, including fatal outcomes, have occurred with
ADCETRIS. Cases were consistent with hepatocellular injury,
including elevations of transaminases and/or bilirubin, and
occurred after the first dose of ADCETRIS or rechallenge.
Preexisting liver disease, elevated baseline liver enzymes, and
concomitant medications may also increase the risk.
- Monitor liver enzymes and bilirubin.
Patients experiencing new, worsening, or recurrent hepatotoxicity
may require a delay, change in dose, or discontinuation of
ADCETRIS.
- Progressive multifocal
leukoencephalopathy (PML): JC virus infection resulting in PML and
death has 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. 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. Hold ADCETRIS if PML is suspected and
discontinue ADCETRIS if PML is confirmed.
- Pulmonary toxicityEvents of
noninfectious pulmonary toxicity including pneumonitis,
interstitial lung disease, and acute respiratory distress syndrome,
some with fatal outcomes, have been reported. Monitor patients for
signs and symptoms of pulmonary toxicity, 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:
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN), including fatal outcomes, have been reported with ADCETRIS.
If SJS or TEN occurs, discontinue ADCETRIS and administer
appropriate medical therapy.
- Gastrointestinal (GI) complications:
Fatal and serious GI complications, including perforation,
hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis,
neutropenic colitis, and ileus have been reported in
ADCETRIS-treated patients. 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 findings in animals, ADCETRIS can cause
fetal harm when administered to a pregnant woman. Females of
reproductive potential should avoid pregnancy during ADCETRIS
treatment and for at least 6 months after the final dose of
ADCETRIS.
Adverse Reactions
In two uncontrolled single-arm trials of ADCETRIS as monotherapy
in 160 patients with relapsed classical HL and sALCL, 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.
In a placebo-controlled trial of ADCETRIS in 329 patients with
classical HL at high risk of relapse or progression post-auto-HSCT,
the most common adverse reactions (≥20%) in the ADCETRIS-treatment
arm (167 patients), regardless of causality, were: neutropenia,
peripheral sensory neuropathy, thrombocytopenia, anemia, upper
respiratory tract infection, fatigue, peripheral motor neuropathy,
nausea, cough, and diarrhea.
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
MMAE exposure and adverse reactions are increased in patients
with moderate or severe hepatic impairment or severe renal
impairment. Avoid use.
Advise females of reproductive potential to avoid pregnancy
during ADCETRIS treatment and for at least 6 months after the final
dose of ADCETRIS.
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
www.ADCETRIS.com.
About Takeda
Takeda Pharmaceutical Company Limited 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 central nervous system
therapeutic areas plus vaccines. Takeda conducts R&D both
internally and with partners to stay at the leading edge of
innovation. New innovative products, especially in oncology and
gastroenterology, as well as our presence in Emerging Markets, fuel
the growth of Takeda. More than 30,000 Takeda employees are
committed to improving quality of life for patients, working with
our partners in health care in more than 70 countries. For more
information, visit http://www.takeda.com/news.
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.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that
develops and commercializes novel antibody-based therapies for the
treatment of cancer. The company’s industry-leading antibody-drug
conjugate (ADC) technology harnesses the targeting ability of
antibodies to deliver cell-killing agents directly to cancer cells.
ADCETRIS® (brentuximab vedotin), the company’s lead product, in
collaboration with Takeda Pharmaceutical Company Limited, is the
first in a new class of ADCs commercially available globally in 67
countries for relapsed classical Hodgkin lymphoma and relapsed
systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics
is also advancing enfortumab vedotin, an ADC for metastatic
urothelial cancer, in a planned pivotal trial in collaboration with
Astellas. Headquartered in Bothell, Washington, Seattle Genetics
has a robust pipeline of innovative therapies for blood-related
cancers and solid tumors designed to address significant unmet
medical needs and improve treatment outcomes for patients. The
company has collaborations for its proprietary ADC technology with
a number of companies including AbbVie, Astellas, Bayer, Celldex,
Genentech, GlaxoSmithKline and Pfizer. More information can be
found at www.seattlegenetics.com
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 the foundation of
care for CD30-expressing lymphomas, anticipated publication of data
from ECHELON-1 and plans 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 safety and/or efficacy results of the ECHELON-1
trial in Hodgkin lymphoma that will not be sufficient for
publication or 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
March 31, 2017 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.
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TakedaJapanese Media:Tsuyoshi Tada, +81 (0)
3-3278-2417tsuyoshi.tada@takeda.comorMedia outside Japan:Sara
Noonan, 617-755-3683sara.noonan@takeda.comorSeattle
GeneticsInvestors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Tricia Larson,
425-527-4180tlarson@seagen.com