-Estimated Five-Year Overall Survival Rate was
60 Percent and Five-Year Progression-Free Survival Rate was 39
Percent-
-In the 66 Percent of Patients who Achieved
Complete Remission, Both Median Overall Survival and
Progression-Free Survival Not Yet Reached-
-Long-Term ADCETRIS Data Continue to Support
Development Strategy to Establish ADCETRIS as Foundation of Therapy
for CD30-Expressing Lymphomas-
Seattle Genetics, Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502)
today announced final data from the ADCETRIS (brentuximab vedotin)
pivotal Phase 2 clinical trial in relapsed or refractory systemic
anaplastic large cell lymphoma (sALCL) were published in the
journal Blood. The manuscript, which summarizes the five-year,
end-of-study results, highlights durable, long-term remissions in
sALCL patients treated with ADCETRIS monotherapy. The manuscript is
available online today and will be included in a future print
edition of Blood. ADCETRIS is an antibody-drug conjugate (ADC)
directed to CD30, which is expressed on the surface of Hodgkin
lymphoma cells and several types of non-Hodgkin lymphoma, including
sALCL. ADCETRIS is being evaluated globally as the foundation of
therapy for CD30-expressing lymphomas in more than 70 corporate-
and investigator-sponsored clinical trials.
“Historically, sALCL patients who have recurrent or refractory
disease have a poor prognosis and outcome with few effective and
durable treatment options,” said Barbara Pro, M.D., Robert H. Lurie
Comprehensive Cancer Center of Northwestern University, Chicago,
Illinois, and lead author of the Blood manuscript. “Publication of
the five-year follow up from the pivotal phase 2 clinical trial
results represents a significant milestone for the sALCL community
by demonstrating that treatment with single-agent brentuximab
vedotin resulted in high response rates and durable, long-term
remissions in conjunction with a manageable safety profile.”
“These data from the pivotal trial in sALCL demonstrate the
long-term clinical benefit of ADCETRIS in the treatment of this
disease, with an estimated five-year survival rate of 60 percent
and progression-free survival rate of 39 percent,” said Jonathan
Drachman, M.D., Chief Medical Officer and Executive Vice President,
Research and Development at Seattle Genetics. “In addition to
achieving sustained remissions in the relapsed sALCL treatment
setting, these data support the evaluation of ADCETRIS in earlier
lines of therapy, including in the ongoing Phase 3 ECHELON-2
clinical trial in frontline mature T-cell lymphoma, also known as
peripheral T-cell lymphoma.”
“With the five-year data of ADCETRIS in relapsed or refractory
classical Hodgkin lymphoma published in Blood in July 2016, these
results in sALCL represent the second CD30-expressing malignancy in
which five-year data has confirmed clinically significant durable
remissions,” said Jesús Gomez-Navarro, M.D., Vice President, Head
of Oncology Clinical Research and Development, Takeda. “These
findings further substantiate our goal to establish ADCETRIS as the
foundation of therapy for CD30-expressing lymphomas.”
The pivotal, single-arm trial, which supported approvals of
ADCETRIS by the FDA in 2011 and the European Medicines Agency (EMA)
in 2012 for this indication, was conducted in 58 relapsed or
refractory sALCL patients to assess the efficacy and safety of
single-agent ADCETRIS. After a follow-up period of approximately
five years, the final results from the pivotal trial include:
- The median overall survival was not yet
reached and median progression-free survival was estimated at 20
months (95% confidence interval [CI]: 9.4, -). The estimated
five-year overall survival and progression-free survival rates were
60 percent and 39 percent, respectively.
- Of the 58 patients treated, 38 patients
(66 percent) had a complete remission, with the median response
duration not reached. For patients who had a complete remission,
the median overall survival and progression-free survival were not
yet reached.
- Sixteen of the 38 patients (42 percent)
who achieved a complete remission continued to be followed and
remained in remission for over five years at study closure. Of
these patients, eight underwent either autologous or allogenic
consolidative stem cell transplants while in remission, and eight
received no further therapy.
- The most common adverse events of any
grade occurring in 20 percent or more of patients were peripheral
neuropathy, nausea, fatigue, pyrexia, diarrhea, rash, constipation
and neutropenia. Of the 33 patients who experienced peripheral
neuropathy, 30 patients (91 percent) experienced complete
resolution or some improvement of symptoms at last follow-up.
About ADCETRIS
ADCETRIS is being evaluated broadly in more than 70 clinical
trials, including four Phase 3 studies: the ECHELON-1 trial in
frontline classical Hodgkin lymphoma from which positive top-line
results were recently reported, the ongoing ECHELON-2 trial in
frontline mature T-cell lymphomas, the completed ALCANZA trial in
cutaneous T-cell lymphoma that supported the supplemental BLA with
a Prescription Drug User Fee Act (PDUFA) target action date of
December 16, 2017, and the recently initiated CHECKMATE 812 trial
of ADCETRIS in combination with Opdivo (nivolumab) for
relapsed/refractory Hodgkin lymphoma.
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-positive 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 in 2013, and
non-conditional approval for post-ASCT consolidation treatment of
Hodgkin lymphoma patients at increased risk of relapse or
progression.
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.
The European Commission extended the current conditional marketing
authorization 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.
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 and is commercially available globally
in 67 countries for relapsed classical Hodgkin lymphoma (HL) and
relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle
Genetics is also advancing enfortumab vedotin, an ADC in a planned
pivotal trial for metastatic urothelial cancer, in collaboration
with Astellas and tisotumab vedotin, an ADC in a phase 1/2 trial
for solid tumors, in collaboration with Genmab. Headquartered in
Bothell, Washington and with European and international operations
in Zug, Switzerland, 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.
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.
ADCETRIS (brentuximab vedotin) U.S. Important Safety
Information
BOXED WARNING
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 peripheral neuropathy 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, 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. Premedicate patients with a prior IRR
before 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 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: Serious cases,
including fatal outcomes, 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: 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. 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:
Noninfectious pulmonary toxicity events including pneumonitis,
interstitial lung disease, and acute respiratory distress syndrome,
some with fatal outcomes, 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:
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 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
Relapsed classical HL and relapsed sALCL: neutropenia,
peripheral sensory neuropathy, fatigue, nausea, anemia, upper
respiratory tract infection, diarrhea, pyrexia, rash,
thrombocytopenia, cough and vomiting.
Classical HL post-auto-HSCT Consolidation: 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
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, and for at least 6
months after the final dose of ADCETRIS treatment.
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.
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.
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) including relating to
the overall and progression free survival rates in sALCL following
treatment with ADCETRIS, future clinical trials and data
availability from clinical trials and possible uses in disease
settings other than those already approved. 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 historical results in clinical trials
for ADCETRIS may not predict results in ongoing or future clinical
trials of ADCETRIS and the data resulting from additional trials
with ADCETRIS may be delayed from the company’s current
expectations and may not support approvals in the studied
indications and the possibility of newly detected adverse safety
events and adverse regulatory action. 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, 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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Seattle GeneticsInvestors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Tricia Larson,
425-527-4180tlarson@seagen.comorTakedaJapanese
Media:Tsuyoshi Tada, +81 (0)
3-3278-2417tsuyoshi.tada@takeda.comorMedia outside Japan:Sara
Noonan, 617-755-3683sara.noonan@takeda.com