-SGN-LIV1A Monotherapy Data Show 37 Percent Objective Response Rate
in Heavily Pretreated Patients withTriple Negative Metastatic
Breast Cancer-
Company Website:
http://www.seattlegenetics.com
SAN ANTONIO -- (Business Wire)
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161210005003/en/
Contacts:
Seattle Genetics, Inc.
Investors:
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
or
Media:
Kavita
V. Shah, Ph.D., 425-527-4188
kshah@seagen.com
Source: Seattle Genetics, Inc.
© 2024 Canjex Publishing Ltd. All rights reserved.