Seattle Genetics Announces Additional Clinical Collaborations to Evaluate SGN-LIV1A in Triple Negative Breast Cancer
October 11 2017 - 8:00AM
Business Wire
-SGN-LIV1A in Combination with Pembrolizumab to
be Investigated as First Line Treatment in a Phase 1b/2 Trial for
Patients with Locally Advanced or Metastatic TNBC-
-SGN-LIV1A to be Evaluated as Part of
Neoadjuvant Treatment in the Phase 2 I-SPY 2 TRIAL for Stage 2-3
Breast Cancer-
Seattle Genetics, Inc. (NASDAQ: SGEN) today announced two
clinical collaboration agreements for the evaluation of SGN-LIV1A
in patients with triple negative breast cancer (TNBC). SGN-LIV1A is
an investigational antibody-drug conjugate (ADC) that targets the
cell surface protein LIV-1, which is expressed on multiple solid
tumors including breast, prostate, melanoma, ovarian, and cervical
cancers. The ADC will be tested in combination with KEYTRUDA®
(pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as
MSD outside the United States and Canada), in a phase 1b/2 clinical
trial as first line treatment for locally advanced and metastatic
TNBC. SGN-LIV1A in combination with standard chemotherapy will also
be evaluated as neoadjuvant treatment in the phase 2 I-SPY 2 TRIAL
for newly diagnosed Stage 2 or 3 human epidermal growth factor
receptor 2 (HER2) negative breast cancer, sponsored by Quantum Leap
Health Care Collaborative (Quantum Leap). This cancer subgroup
accounts for up to 85 percent of breast cancer and includes
TNBC.
“Our new collaborations expand the clinical investigation of
SGN-LIV1A by evaluating this ADC in earlier lines of treatment for
TNBC, including the frontline setting in combination with
pembrolizumab. In the neoadjuvant setting, SGN-LIV1A has the
potential to benefit a broader population of women with breast
cancer,” said Jonathan Drachman, M.D., Chief Medical Officer and
Executive Vice President, Research and Development at Seattle
Genetics. “Breast cancer is the most common cancer in women,
excluding some forms of skin cancer, in the United States. Of the
over 250,000 new cases expected to be diagnosed in the US this
year, about 15 to 20 percent are TNBC, which is very aggressive and
associated with poor patient outcomes. With four clinical studies
underway or planned for SGN-LIV1A in TNBC, we are advancing our
goal to improve the health of women with this devastating
disease.”
SGN-LIV1A administered in combination with Merck’s pembrolizumab
will be evaluated in a phase 1b/2 clinical study in patients with
locally advanced or metastatic TNBC. This single arm, open label
multicenter study is anticipated to enroll up to 72 patients. Under
the terms of the collaboration agreement with Merck, Seattle
Genetics will hold the IND for the study and retain global
development and commercialization rights to SGN-LIV1A.
SGN-LIV1A followed by standard chemotherapy (doxorubicin and
cyclophosphamide) will be evaluated as a neoadjuvant treatment
(prior to surgery) for women with newly diagnosed, locally advanced
Stage 2 or 3 HER2-negative breast cancer in the I-SPY 2 TRIAL. This
standing phase 2 randomized, controlled multicenter trial is
anticipated to enroll up to 75 patients in the SGN-LIV1A treatment
arm. With TNBC and other aggressive cancers in mind, the I-SPY 2
TRIAL was designed to rapidly screen promising experimental
treatments and identify those most effective in specific patient
subgroups based on molecular characteristics (biomarker
signatures). The trial is a unique collaborative effort by a
consortium that includes the Food and Drug Administration (FDA),
industry, patient advocates, philanthropic sponsors and clinicians
from 20 major U.S cancer research centers. Under the terms of the
collaboration agreement, Quantum Leap is the trial sponsor and will
manage the study operations. Seattle Genetics will retain global
development and commercialization rights to SGN-LIV1A.
Four clinical studies are underway or planned for SGN-LIV1A in
breast cancer, with a focus on TNBC. In addition to the
aforementioned trials, SGN-LIV1A monotherapy is being evaluated in
an ongoing phase 1 trial for patients with metastatic breast
cancer, including patients heavily pre-treated for TNBC. A phase
1b/2 trial is planned to evaluate SGN-LIV1A as part of a
combination regimen as second line treatment for patients with
metastatic TNBC who have not been previously treated with
immunotherapy.
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 as 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 most common cancer in women
worldwide with an estimated 1.67 million new cancer cases diagnosed
in 2012. In addition, breast cancer ranks as the fifth cause of
death from cancer overall globally. 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 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 cancers. 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 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.
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 for treatment of breast cancer, its possible
benefits and uses, as monotherapy or in combination with other
clinical agents, and the timing, size, conduct or continuation of
the referenced clinical trials. 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 of SGN-LIV1A to show sufficient
activity in the clinical settings referenced above, the risk of
adverse events of SGN-LIV1A alone or in combination with other
clinical agents, and the possibility the referenced trials could be
discontinued. 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 August 1, 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.,
USA.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171011005097/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Kavita V. Shah, Ph.D.,
425-527-4188kshah@seagen.com
Seagen (NASDAQ:SGEN)
Historical Stock Chart
From Apr 2024 to May 2024
Seagen (NASDAQ:SGEN)
Historical Stock Chart
From May 2023 to May 2024