|[January 13, 2014]
Seattle Genetics Highlights Key 2014 Milestones and Activities at J.P. Morgan Healthcare Conference
BOTHELL, Wash. --(Business Wire)--
Genetics, Inc. (Nasdaq: SGEN) today highlighted several anticipated
2014 milestones related to ADCETRIS (brentuximab vedotin) and its
antibody-drug conjugate (ADC (News - Alert)) pipeline programs in a presentation at the
32nd J.P. Morgan Healthcare Conference on Monday, January 13,
2014 at 9:30 a.m. Pacific Time. Highlights include:
The company announced that it has aligned with collaborator Takeda
Pharmaceutical Company Limited (Takeda), as well as with the U.S. Food
and Drug Administration (FDA) and European Union regulators, on a
protocol amendment to unblind the phase 3 AETHERA clinical trial in
the second half of 2014.
Under the collaboration with Takeda, ADCETRIS recently received
marketing authorization in Australia and Singapore, and regulatory
approvals are being pursued in multiple other countries globally
during 2014, including Japan.
ADCETRIS was recently added to the National Comprehensive Cancer
Network (NCCN) guidelines for the treatment of relapsed CD30-positive
peripheral T-cell lymphoma (PTCL).
Seattle Genetics reviewed anticipated 2014 data presentations and
program milestones from its portfolio of ADC programs, including a
broad clinical development program evaluating ADCETRIS for the
treatment of CD30-positive malignancies and progress with ADC
candidates SGN (News - Alert)-CD19A, SGN-CD33A and SGN-CD70A.
"Our leadership in the field of antibody-drug conjugates, or ADCs, is
exemplified by our substantial progress in developing and
commercializing ADCETRIS and advancing our pipeline of five other ADC
candidates in clinical trials," said Clay B. Siegall, Ph.D., President
and Chief Executive Officer at Seattle Genetics. "We anticipate
significant milestones during 2014, including data from the ADCETRIS
phase 3 AETHERA clinical trial as well as from phase 2 clinical trials
in diffuse large B-cell lymphoma (DLBCL) and salvage Hodgkin lymphoma
(HL). We also anticipate reporting additional data from phase 1 clinical
trials evaluating SGN-CD19A in acute lymphocytic leukemia (ALL) and
non-Hodgkin lymphoma, as well as the first clinical data from a phase 1
clinical trial evaluating SGN-CD33A in acute myeloid leukemia (AML).
Lastly, we anticipate advancing SGN-CD70A, our sixth ADC pipeline
program, into clinical evaluation during 2014."
ADCETRIS 2014 Milestones
ADCETRIS is being evaluated in more than 30 ongoing clinical trials,
including four phase 3 trials, designed to establish it as the
foundation of therapy for CD30-positive malignancies. The phase 3
AETHERA trial is evaluating ADCETRIS versus placebo for the treatment of
patients at high risk of residual HL following autologous stem cell
transplant (ASCT) to determine if ADCETRIS can extend progression-free
survival in a consolidation or maintenance-type setting for these
post-ASCT HL patients. Based on current estimates of progression events
from pooled, blinded data from the ongoing trial, the study has been
amended to enable a time point-driven progression-free survival analysis
after patients have completed all required scans, which is anticipated
to occur in the second half of 2014. The AETHERA trial is not being
conducted under a Special Protocol Assessment (SPA) agreement from the
FDA and has not been designated as a confirmatory trial to convert
either accelerated approval or conditional marketing authorization to
regular approval. This trial will provide drug safety data analyses that
fulfill one of the company's FDA post-approval requirements.
In addition, data presentations from several ongoing ADCETRIS studies
are expected at medical forums in 2014, including data from:
a phase 1/2 study in combination with bendamustine in second-line HL;
clinical trials in relapsed B-cell non-Hodgkin lymphoma, including
follow-up from a phase 2 trial in frontline HL patients age 60 and
ADCETRIS is currently approved for only 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 systemic
anaplastic large-cell lymphoma (sALCL) after failure of at least one
prior multi-agent chemotherapy regimen.
ADC Pipeline Program 2014 Milestones
Seattle Genetics has a robust pipeline of ADC programs in ongoing
clinical trials, including SGN-CD19A, SGN-CD33A, SGN-LIV1A, ASG-22ME and
SGN-CD19A is an ADC targeting CD19, a protein expressed uniformly on
most B-cell malignancies, which is being evaluated in phase 1 clinical
trials for the treatment of ALL and non-Hodgkin lymphoma. Data presented
at the 55th American Society of Hematology (ASH) Annual
Meeting in December 2013 demonstrated encouraging early antitumor
activity and a generally well-tolerated safety profile among heavily
pretreated patients with ALL. In addition, multiple complete remissions
have been observed in a parallel phase 1 studyevaluating SGN-CD19A in
aggressive non-Hodgkin lymphoma. Additional data from both ongoing phase
1 clinical trials are expected to be presented in 2014.
SGN-CD33A is a novel CD33-directed ADC utilizing Seattle Genetics' next
generation technology. The CD33 antibody is attached to a highly potent
cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer via a
proprietary site-specific conjugate technology to a monoclonal antibody
with engineered cysteines (EC-mAb). SGN-CD33A is being evaluated in a
phase 1 clinical trial for patients with AML. The first presentation of
clinical data from SGN-CD33A is expected during 2014.
Seattle Genetics is also advancing SGN-LIV1A, ASG-22ME and ASG-15ME in
ongoing phase 1 clinical trials for a variety of solid tumor types.
The company also plans to advance SGN-CD70A, a novel CD70-directed ADC
utilizing its proprietary PBD dimer and EC-mAb technologies, into phase
1 clinical trials during 2014. SGN-CD70A will be the company's sixth ADC
pipeline program currently in clinical evaluation.
Antibody-drug conjugates (ADCs) are monoclonal antibodies that are
designed to selectively deliver cytotoxic agents to tumor cells. This
approach is intended to spare non-targeted cells and thus reduce many of
the toxic effects of traditional chemotherapy while enhancing antitumor
activity. ADCETRIS is an ADC directed to CD30, a defining marker of
classical HL and known to be expressed in some types of non-Hodgkin
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 FDA 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
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. ADCETRIS has received marketing authorization by
regulatory authorities in more than 35 countries. See important safety
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.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development
and commercialization of innovative antibody-based therapies for the
treatment of cancer. Seattle Genetics is leading the field in developing
antibody-drug conjugates (ADCs), a technology designed to harness the
targeting ability of antibodies to deliver cell-killing agents directly
to cancer cells. The company's lead product, ADCETRIS®
(brentuximab vedotin) is an ADC that, in collaboration with Takeda
Pharmaceutical Company Limited, has been approved for two indications in
more than 35 countries, including the U.S., Canada and members of the
European Union. Additionally, ADCETRIS is being evaluated broadly in
more than 30 ongoing clinical trials. Seattle Genetics is also advancing
a robust pipeline of clinical-stage ADC programs, including SGN-CD19A,
SGN-CD33A, SGN-LIV1A, ASG-22ME and ASG-15ME. Seattle Genetics has
collaborations for its ADC technology with a number of leading
biotechnology and pharmaceutical companies, including AbbVie, Agensys
(an affiliate of Astellas), Bayer, Genentech, GlaxoSmithKline and
Pfizer. More information can be found at www.seattlegenetics.com.
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection
resulting in PML and death can occur in patients receiving ADCETRIS.
Concomitant use of ADCETRIS and bleomycin is contraindicated due to
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
Infusion reactions: Infusion-related reactions, including anaphylaxis,
have occurred with ADCETRIS. Monitor patients during infusion. If an
infusion reaction occurs, interrupt the infusion. If anaphylaxis
occurs, immediately and permanently discontinue the infusion.
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
Embryo-fetal toxicity: Fetal harm can occur. Advise pregnant women of
the potential hazard to the fetus.
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.
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.
For additional important safety information, including Boxed WARNING,
please see the full U.S. prescribing information for ADCETRIS at www.seattlegenetics.com
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to therapeutic potential
of ADCETRIS, SGN-CD19A, SGN-CD33A, SGN-LIV1A, ASG-22ME, ASG-15ME and
SGN-CD70A. 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 the inability to show
sufficient activity in the AETHERA trial necessary for approval and the
risk of adverse events as ADCETRIS, SGN-CD19A, SGN-CD33A, SGN-LIV1A,
ASG-22ME, ASG-15ME and SGN-CD70A advance in clinical trials. In
addition, data from our clinical trials, including our pivotal trials
which were the basis for FDA accelerated approval, may not necessarily
be indicative of subsequent clinical trial results. More information
about the risks and uncertainties faced by Seattle Genetics is contained
in the company's 10-Q for the quarter ended September 30, 2013 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
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