Seattle Genetics Highlights Phase 1 Data for Novel Antibody-Drug Conjugate SGN-LIV1A in Patients with Metastatic Breast Cance...
December 10 2016 - 7:30AM
Business Wire
-SGN-LIV1A Monotherapy Data Show 37 Percent
Objective Response Rate in Heavily Pretreated Patients with Triple
Negative Metastatic Breast Cancer-
Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology
company, today presented data from an ongoing phase 1 clinical
trial evaluating SGN-LIV1A for patients with metastatic breast
cancer (MBC), with particular focus on triple-negative MBC (TN
MBC), at the 39th San Antonio Breast Cancer Symposium (SABCS)
taking place in San Antonio, Texas, December 6-10, 2016. SGN-LIV1A
is an investigational antibody-drug conjugate (ADC) which consists
of a LIV-1-targeted monoclonal antibody linked to the cell-killing
agent monomethyl auristatin E (MMAE) by a protease-cleavable
linker. LIV-1 is a protein expressed by most metastatic breast
cancers. SGN-LIV1A is one of four clinical-stage empowered antibody
therapies under development by Seattle Genetics for solid
tumors.
“Breast cancer is the most common cancer among women, with an
estimated 1.67 million new cases per year worldwide. About 15 to 20
percent of breast cancers are triple negative, which means they
lack expression of three breast cancer-associated proteins that
serve as key therapeutic targets. Triple-negative breast cancers
are more aggressive and generally have poor prognoses,” said
Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice
President, Research and Development at Seattle Genetics. “The data
presented at SABCS on SGN-LIV1A demonstrate promising early
antitumor activity with a 37 percent partial response rate in
patients with triple negative metastatic breast cancer, for which
there are no available targeted treatments. We are enrolling
additional patients with triple negative metastatic breast cancer
in our phase 1 study to optimize the dose and inform the next steps
for development of SGN-LIV1A in this population with high unmet
need.”
Interim data from the ongoing phase 1 study of SGN-LIV1A in
patients with MBC were previously presented at the 2015 SABCS. The
following updated results from this trial describe safety data for
all patients and antitumor activity data for patients with TN
MBC.
Interim Analysis of a Phase 1 Study of the Antibody-Drug
Conjugate SGN-LIV1A in Patients with Metastatic Breast Cancer
(Poster# P6-12-04, Poster Session 6 - Treatment: New Drugs and
Treatment Strategies at 7:30 – 9:00 a.m. CT on Saturday, December
10, 2016)
Data were reported from 53 patients with LIV-1-expressing MBC
who were treated with SGN-LIV1A monotherapy administered every
three weeks. Of these patients, 35 had TN MBC. The median age of
all patients was 56 years. Patients had received a median of four
prior systemic therapies for metastatic disease. Key findings
presented by Dr. Andres Forero-Torres, University of Alabama at
Birmingham included:
- Thirty of 47 efficacy-evaluable
patients had TN MBC. Among these patients, 11 (37 percent) achieved
a partial response (PR). The disease control rate (DCR) was 67
percent and the clinical benefit rate (CBR) was 47 percent. DCR is
defined as patients achieving a complete response (CR), PR or
stable disease (SD). CBR is defined as patients achieving CR or PR
of any duration plus patients achieving SD lasting at least 24
weeks.
- At the time of this interim data
analysis, the estimated median progression-free survival for TN MBC
patients was 12 weeks with seven patients remaining on
treatment.
- The maximum tolerated dose was not
reached among doses ranging from 0.5 to 2.8 milligrams per kilogram
(mg/kg). Dose escalation is complete and a disease-specific
expansion cohort of TN MBC patients is currently enrolling.
- For all patients in the study, the most
common adverse events of any grade occurring in 20 percent or more
of patients included fatigue (57 percent), nausea (53 percent),
alopecia (42 percent), decreased appetite (34 percent) and
constipation (32 percent).
- The incidence of grade 3/4 neutropenia
at the 2.5 mg/kg dose was 50 percent. Two patients (seven percent)
experienced febrile neutropenia, and there was one
treatment-related death due to sepsis. Based on these safety data,
a separate expansion cohort at 2.0 mg/kg is currently being
evaluated.
- Peripheral neuropathy events occurred
in 38 percent of patients and were generally low grade and
manageable.
- Enrollment continues for patients with
TN MBC in the SGN-LIV1A monotherapy part of the study. In addition,
enrollment is ongoing for patients with HER2+ breast cancer to
evaluate SGN-LIV1A in combination with trastuzumab.
More information about the SGN-LIV1A phase 1 clinical trial,
including enrolling centers, is available by visiting
www.clinicaltrials.gov.
About SGN-LIV1A
SGN-LIV1A is a novel investigational ADC targeted to LIV-1
protein utilizing Seattle Genetics’ proprietary ADC technology.
LIV-1 is expressed by most metastatic breast cancers. It has also
been detected in a number of other cancers, including melanoma,
prostate, ovarian, and cervical cancer. SGN-LIV1A consists of a
LIV-1-targeted monoclonal antibody linked to a potent
microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a
protease-cleavable linker, using the same technology as ADCETRIS
(brentuximab vedotin). It is designed to bind to LIV-1 on cancer
cells and release the cell-killing agent into target cells upon
internalization. SGN-LIV1A may also cause antitumor activity
through other mechanisms, including activation of an immune
response.
About Breast Cancer
Breast cancer is a cancer which forms in breast tissue.
Metastatic breast cancer occurs when the cancer has spread to other
parts of the body. While most new diagnoses of breast cancer are
made at an early stage, approximately one-third of these patients
will eventually develop recurrent or metastatic disease. Breast
cancers are commonly categorized by the expression (or lack
thereof) of three key proteins, which serve are targets for
therapeutics. These include the estrogen receptor (ER),
progesterone receptor (PR), and human epidermal growth factor
receptor 2 (HER2). Triple-negative breast cancer (TNBC) lacks all
three proteins and HR+/HER2- breast cancer expresses one or both
hormone receptors (HR) but not HER2. According to the World Health
Organization, breast cancer is the second most common cancer in the
world and the most frequent cancer among women with an estimated
1.67 million new cancer cases diagnosed in 2012. Furthermore,
breast cancer ranks as the fifth cause of death from cancer
overall. New treatment approaches are needed to improve outcomes
for breast cancer patients, particularly for those with TNBC where
there are currently no available targeted therapies.
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 65
countries for relapsed classical Hodgkin lymphoma (HL) and relapsed
systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics
is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in
a phase 3 trial for acute myeloid leukemia. 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
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of SGN-LIV1A and its possible benefits and uses, and
planned development activities including clinical trials to
optimize dose. 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 this recently initiated
clinical trial and the risk of adverse events as SGN-LIV1A advances
in clinical trials and regulatory actions. 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,
2016 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/20161210005003/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Kavita V. Shah, Ph.D.,
425-527-4188kshah@seagen.com
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