– First Presentation of Initial Data from a
Phase 1 Trial of Enfortumab Vedotin Plus Pembrolizumab in Locally
Advanced or Metastatic Urothelial Cancer Featured in an Oral
Session –
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that new
data from four of its investigational programs will be presented at
the upcoming European Society for Medical Oncology (ESMO) 2019
Congress in Barcelona, Spain, from September 27 - October 1,
2019.
“We look forward to the presentation featuring antibody-drug
conjugate enfortumab vedotin in combination with the immune therapy
pembrolizumab in patients with previously untreated advanced
urothelial cancer,” said Roger Dansey, M.D., Chief Medical Officer
at Seattle Genetics. “We are also pleased to see initial results
from an investigator-sponsored study called MOUNTAINEER examining
the combination of our novel tyrosine kinase inhibitor tucatinib
with trastuzumab for the treatment of HER2-amplified metastatic
colorectal cancer. The development of these and other targeted
medicines support our efforts toward becoming a multi-product
oncology company.”
Details of the oral
presentation:
EV-103: Initial results of enfortumab vedotin plus
pembrolizumab for locally advanced or metastatic urothelial
carcinoma Abstract: 901O Presenter: C Hoimes,
Case Western Reserve University, Cleveland, OH, USA Session:
Oral Presentation Proffered Paper Session – Genitourinary tumours,
non-prostate Date and Time: Saturday, September 28,
8:30-10:00 a.m. CEST Location: Barcelona Auditorium, Hall
2
Details of company-sponsored
presentations are as follows:
Systemic therapy in 2nd-line metastatic triple negative
breast cancer (mTNBC): a systematic literature review (SLR) and
meta-analysis (MA) of efficacy Abstract: 360P First
Author: PA Kaufman, University of Vermont Cancer Center,
Burlington, VT, USA Session: Poster Presentation Date and
Time: Sunday, September 29, 12:00-1:00 p.m. CEST
Location: Barcelona Auditorium, Hall 4
Quality of life of metastatic urothelial cancer (mUC)
patients treated with enfortumab vedotin (EV) following
platinum-containing chemotherapy and a checkpoint inhibitor (CPI):
data from EV-201 cohort 1 Abstract: 921P First
Author: B McGregor, Dana-Farber Cancer Institute, Boston, MA,
USA Session: Poster Presentation Date and Time:
Monday, September 30, 12:00-1:00 p.m. CEST Location:
Barcelona Auditorium, Hall 4
Phase 1/2 trial of tisotumab vedotin plus bevacizumab,
pembrolizumab, or carboplatin in recurrent or metastatic cervical
cancer (innovaTV 205/ENGOT-cx8) Abstract: 1059TiP
First Author: I Vergote, Leuven Cancer Institute, Leuven,
Belgium Session: Poster Presentation Date and Time:
Sunday, September 29, 12:00-1:00 p.m. CEST Location:
Barcelona Auditorium, Hall 4
Details of select
investigator-initiated trial presentation is as
follows:
Trastuzumab and tucatinib for the treatment of HER2 amplified
metastatic colorectal cancer (mCRC): Initial results from the
MOUNTAINEER trial Abstract: 527PD First Author:
JH Strickler, Duke University Medical Centre, Durham, NC, USA
Session: Poster Discussion Session – Gastrointestinal
tumours, colorectal Date and Time: Sunday, September 29,
Poster Discussion: 3:00-3:15 p.m. CEST Location: Cordoba
Auditorium, Hall 7
For more information, including a complete list of abstract
titles and presentation dates and times, visit the ESMO website at
https://cslide.ctimeetingtech.com/esmo2019/attendee/confcal.
About Enfortumab Vedotin
Enfortumab vedotin is an investigational antibody-drug conjugate
(ADC) composed of an anti-Nectin-4 monoclonal antibody attached to
a microtubule-disrupting agent, MMAE, using Seattle Genetics’
proprietary linker technology. Enfortumab vedotin targets Nectin-4,
a cell adhesion molecule that is expressed on many solid tumors,
and that has been identified as an ADC target by Astellas. A
Biologics License Application is currently under review by the U.S.
Food and Drug Administration (FDA) for the treatment of patients
with locally advanced or metastatic urothelial cancer who have
received a PD-1/PD-L1 inhibitor and who have received a
platinum-containing chemotherapy before (neoadjuvant) or after
(adjuvant) surgery or in a locally advanced or metastatic setting.
Enfortumab vedotin is being co-developed by Seattle Genetics and
Astellas Pharma Inc.
The safety and efficacy of enfortumab vedotin are under
investigation and have not been established. There is no guarantee
that the agent will receive regulatory approval or become
commercially available for the uses being investigated.
About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed
of Genmab’s human antibody that binds to Tissue Factor and Seattle
Genetics’ ADC technology that utilizes a cleavable linker and the
microtubule disrupting agent monomethyl auristatin E (MMAE). In
cancer biology, Tissue Factor is a protein involved in tumor
signaling and angiogenesis. The Tissue Factor antigen target is
overexpressed in the vast majority of patients with cervical cancer
and in many other solid tumors, including ovarian, lung,
pancreatic, colorectal and head and neck. Based on its high
expression on many solid tumors and its rapid internalization,
Tissue Factor was selected as a target for an ADC approach.
Tisotumab vedotin is being co-developed by Seattle Genetics and
Genmab.
About Tucatinib
Tucatinib is an investigational, orally bioavailable, potent
tyrosine kinase inhibitor that is highly selective for HER2 without
significant inhibition of EGFR. Inhibition of EGFR has been
associated with significant toxicities, including skin rash and
diarrhea. Tucatinib has shown activity as a single agent and in
combination with both chemotherapy and other HER2 directed agents
such as trastuzumab.1 Studies of tucatinib in these combinations
have shown activity both systemically and in brain metastases. 1
HER2 is a growth factor receptor that is overexpressed in multiple
cancers, including breast, ovarian and gastric cancers. HER2
mediates cell growth, differentiation and survival. Tumors that
overexpress HER2 are more aggressive and historically have been
associated with poor overall survival compared with HER2-negative
cancers. Tucatinib has been granted orphan drug designation by the
FDA for the treatment of breast cancer patients with brain
metastases.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes
transformative therapies targeting cancer to make a meaningful
difference in people’s lives. ADCETRIS® (brentuximab vedotin)
utilizes the company’s industry-leading antibody-drug conjugate
(ADC) technology and is currently approved for the treatment of
multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company
has established a pipeline of novel targeted therapies at various
stages of clinical testing, including three in ongoing pivotal
trials for solid tumors. Enfortumab vedotin for metastatic
urothelial cancer and tisotumab vedotin for metastatic cervical
cancer utilize our proprietary ADC technology. Tucatinib, a small
molecule tyrosine kinase inhibitor, is in a pivotal trial for
HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a
portfolio of proprietary immuno-oncology agents in clinical trials
targeting hematologic malignancies and solid tumors. The company is
headquartered in Bothell, Washington, and has a European office in
Switzerland. For more information on our robust pipeline, visit
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 possible
utility or application of the Company’s technologies to develop
therapeutic agents, therapeutic potential of investigational
agents, and future development activities including 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 difficulty and
uncertainty of pharmaceutical product development, including the
risks that Seattle Genetics may experience delays in its planned
clinical trial initiations or otherwise experience failures or
setbacks in its preclinical and clinical development programs due
to the potential lack of efficacy or risk of adverse events or
other factors. 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 June 30, 2019 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.
References:
1. Murthy, R. et al., Tucatinib with capecitabine and
trastuzumab in advanced HER2-positive metastatic breast cancer with
and without brain metastases: a non-randomised, open-label, phase
1b study. Lancet Oncol. 2018; May 2018.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190917005413/en/
Media: Monique Greer (425) 527-4641 mgreer@seagen.com
Investors: Peggy Pinkston (425) 527-4160
ppinkston@seagen.com
Seagen (NASDAQ:SGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Seagen (NASDAQ:SGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024