-Estimated Five-Year Progression-Free Survival
Rate of 52 Percent and Overall Survival Rate of 80 Percent, with No
Disease Progression Events Since the Three-Year Follow-up Data-
-Long-Term ADCETRIS Data Continue to Support
Development Strategy to Redefine Frontline Treatment of MTCL
Through Ongoing Phase 3 ECHELON-2 Clinical Trial-
Seattle Genetics, Inc. (Nasdaq: SGEN) today highlighted final
five-year survival results from a phase 1 clinical trial evaluating
ADCETRIS (brentuximab vedotin) in mature T-cell lymphoma (MTCL) at
the 59th American Society of Hematology (ASH) Annual Meeting and
Exposition taking place in Atlanta, Georgia, December 9-12, 2017.
The presentation highlighted durability data from a phase 1
clinical trial of ADCETRIS in combination with chemotherapy for the
treatment of patients with newly diagnosed MTCL, also known as
peripheral T-cell lymphoma (PTCL). 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. ADCETRIS is currently not approved for the frontline
treatment of MTCL.
“Approximately 4,000 patients are diagnosed with MTCL each year.
The current standard of care for frontline MTCL treatment has not
changed for several decades and there remains a significant need
for improved therapeutic options. The results of this phase 1 trial
support the ongoing phase 3 ECHELON-2 clinical trial and our goal
to redefine frontline MTCL treatment with a novel ADCETRIS
combination regimen,” said Jonathan Drachman, M.D., Chief Medical
Officer and Executive Vice President, Research and Development at
Seattle Genetics. “The final results from the phase 1 study were
presented today, with five-year progression-free survival and
overall survival rates of 52 and 80 percent, respectively. No
patients have experienced any disease progression events since the
three-year follow-up results. Importantly, after more than five
years of follow-up, patients who remain in remission have the
potential to be cured. These data continue to support the phase 3
ECHELON-2 trial, from which we anticipate reporting data in
2018.”
Five-Year Survival Results: Frontline Brentuximab Vedotin in
Combination with CHP in Patients with CD30-Expressing Peripheral
T-Cell Lymphomas (Abstract #2790, poster presentation on Sunday,
December 10, 2017)
Data were reported from 26 frontline MTCL patients who received
the combination regimen of ADCETRIS plus cyclophosphamide,
doxorubicin and prednisone (CHP). Patients who achieved at least a
partial remission with combination therapy following six cycles of
ADCETRIS plus CHP were eligible to receive up to ten additional
cycles of single-agent ADCETRIS treatment. The median age of
patients was 56 years. Nineteen patients (73 percent) had a subtype
of MTCL called systemic anaplastic large cell lymphoma (sALCL),
including 16 patients with anaplastic lymphoma kinase
(ALK)-negative disease, which is typically associated with a poor
prognosis. Seven patients (27 percent) had a diagnosis of other
types of MTCL. The majority of patients had advanced stage disease
and were considered high risk. All patients on the trial achieved
an objective response, including 92 percent with a complete
response and eight percent with a partial response.
Updated key findings based on a median observation time of 60
months from first dose of therapy include:
- At five-year follow-up, there have been
no progression events or deaths in this trial since the three-year
follow up.
- The estimated five-year
progression-free survival rate was 52 percent, with no patients
receiving a consolidative stem cell transplant in first remission.
The median progression-free survival has not yet been reached.
- The estimated five-year overall
survival rate was 80 percent. The median overall survival has not
yet been reached.
- Seventy-three percent of patients (19
of 26) experienced peripheral neuropathy, the majority of which was
Grade 1 or 2. Ninety-five percent of these patients had complete
resolution or some improvement of their symptoms at last follow-up
with a median time to resolution of 4.2 months and median time to
improvement of symptoms was 2.6 months.
A global phase 3 study called ECHELON-2 completed enrollment in
November 2016. The ECHELON-2 trial is a randomized, double-blind,
placebo-controlled, multi-center trial designed to investigate
ADCETRIS plus CHP versus CHOP as frontline therapy in patients with
CD30-expressing MTCL. The trial enrolled 452 patients
(approximately 225 patients per treatment arm) randomized to
receive ADCETRIS plus CHP or CHOP every three weeks for six to
eight cycles. Data from the ECHELON-2 trial are expected in
2018.
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. Non-Hodgkin
lymphomas 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. T-cell
lymphomas account for approximately 15 percent of all non-Hodgkin
lymphoma in the United States. 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). Almost all types of T-cell lymphoma fall under the
category of mature T-cell lymphoma, also known as peripheral T-cell
lymphoma. According to the American Cancer Society and analysis of
literature sources, approximately 4,300 patients will be diagnosed
with CD30-expressing mature T-cell lymphoma in the United States
during 2017.
About ADCETRIS
ADCETRIS is being evaluated broadly in more than 70 clinical
trials, including three phase 3 studies: the completed ECHELON-1
trial in frontline classical Hodgkin lymphoma that supported the
recent FDA Breakthrough Therapy Designation and submission of the
supplemental Biologics License Application (BLA) for use in this
setting, the ongoing ECHELON-2 trial in frontline mature T-cell
lymphomas, and the ongoing 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-expressing tumor cells.
ADCETRIS injection for intravenous infusion has received FDA
approval for four indications: (1) regular approval for adult
patients with primary cutaneous anaplastic large cell lymphoma
(pcALCL) or CD30-expressing mycosis fungoides (MF) who have
received prior systemic therapy, (2) 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, (3) regular
approval for the treatment of classical Hodgkin lymphoma patients
at high risk of relapse or progression as post-auto-HSCT
consolidation, and (4) 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 69 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
dedicated to improving the lives of people with cancer through
novel antibody-based therapies. 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. Seattle Genetics commercializes ADCETRIS®
(brentuximab vedotin) for the treatment of several types of
CD30-expressing lymphomas. The company is also advancing a robust
pipeline of novel therapies for solid tumors and blood-related
cancers designed to address significant unmet medical needs and
improve treatment outcomes for patients. More information can be
found at www.seattlegenetics.com and follow @SeattleGenetics on
Twitter.
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
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:
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: Acute pancreatitis, including fatal outcomes,
has been reported in ADCETRIS-treated patients. Other 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: peripheral sensory
neuropathy, fatigue, nausea, diarrhea, neutropenia, upper
respiratory tract infection, 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, 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.
Forward-Looking Statement:
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic and commercial potential of ADCETRIS, including
ADCETRIS’ potential as a treatment for MTCL, the potential of
patients in the study to receive future long-term benefits
including possibly to be cured from their disease, and Seattle
Genetics’ goal to redefine frontline MTCL treatment with a novel
ADCETRIS combination regimen, the anticipated benefits of Seattle
Genetics’ ADCETRIS clinical development program, and the potential
submission of applications (e.g., a supplemental Biologics License
Application in the U.S.) seeking label expansion for ADCETRIS use
in the ECHELON-2 setting. 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
risks of adverse events associated with ADCETRIS use, negative or
unexpected results from the phase 1 or ECHELON-2 trials even after
promising results in earlier company- and investigator-sponsored
trials, and adverse regulatory actions affecting ADCETRIS, all of
which could result in Seattle Genetics being unable to expand
ADCETRIS’ labeled indications of use to the ECHELON-2 or any other
settings. Seattle Genetics may also experience delays in the
conduct of and obtaining data from the ECHELON-2 and its other
clinical trials, in each case for a variety of reasons, including
the inherent difficulty and uncertainty of pharmaceutical product
development. 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 September 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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version on businesswire.com: http://www.businesswire.com/news/home/20171210005021/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Tricia Larson,
425-527-4180tlarson@seagen.com
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