Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
March 29 2019 - 8:00AM
Business Wire
-Phase 2 innovaTV 204 Trial Designed to Support
Potential Accelerated Approval Pathway in U.S.-
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced completion
of enrollment in the potentially pivotal innovaTV 204 phase 2
clinical trial evaluating the efficacy, safety and tolerability of
tisotumab vedotin as monotherapy for patients with recurrent and/or
metastatic cervical cancer who have relapsed or progressed after
standard of care treatment. Tisotumab vedotin is being developed in
collaboration with Genmab A/S. The innovaTV 204 trial is intended
to support potential registration under the U.S. Food and Drug
Administration’s (FDA) accelerated approval regulations. Tisotumab
vedotin is an investigational antibody-drug conjugate (ADC)
designed to target Tissue Factor antigen on cancer cells and
deliver the cell-killing agent monomethyl auristatin E (MMAE)
directly inside cancer cells. Tissue Factor is overexpressed in
cervical cancer and many other solid tumors.
“Cervical cancer is a devastating disease with a significant
need to develop improved therapies for patients with metastatic
disease who have progressed after treatment,” said Roger Dansey,
M.D., Chief Medical Officer at Seattle Genetics. “Completing
enrollment in this potentially pivotal phase 2 trial marks an
important step forward in evaluating tisotumab vedotin for women
with previously treated recurrent and/or metastatic cervical
cancer.”
For more information about the phase 2 innovaTV 204 clinical
trial and other clinical trials with tisotumab vedotin, please
visit www.clinicaltrials.gov.
About innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04) is an ongoing
single-arm, global, multicenter study of tisotumab vedotin for
patients with recurrent and/or metastatic cervical cancer who
progressed on or relapsed after treatment with doublet chemotherapy
used alone or in combination with bevacizumab (Avastin®). The study
enrolled over 100 patients at multiple centers. The primary
endpoint of the trial is objective response rate as assessed by
blinded independent central review. Key secondary endpoints include
duration of response, progression-free survival, overall survival,
safety and tolerability.
About Cervical Cancer
Cervical cancer originates in the cells lining the cervix, which
connects the uterus to the birth canal. About 13,000 women are
expected to be diagnosed with cervical cancer in the U.S. in 2018,
with an estimated 4,000 deaths.1 Cervical cancer remains one of the
leading causes of cancer death in women globally, with over 311,000
women dying annually; the vast majority of these women being in the
developing world.2 Routine medical examinations and the human
papillomavirus (HPV) vaccine have lowered the incidence of cervical
cancer in the developed world. Despite these advances, women are
still diagnosed with cervical cancer, which can have a devastating
impact, particularly in the recurrent and/or metastatic setting.
Standard therapies for previously treated recurrent and/or
metastatic cervical cancer generally result in response rates of
less than 15 percent and a median overall survival of 6 to 8
months.3-10
About Tisotumab Vedotin
Tisotumab vedotin is an 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.
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 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 therapeutic
potential of tisotumab vedotin, its possible benefits and uses as
monotherapy, and the referenced Phase 2 clinical trial. 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 tisotumab vedotin
to show sufficient activity in the clinical setting referenced
above and the risk of adverse events of tisotumab vedotin,
including the potential for newly-emerging safety signals, delays
in planned clinical trial initiations, enrollment and conduct,
obtaining data from clinical trials, and anticipated regulatory
submissions and approvals in each case for a variety of reasons,
including the difficulty and uncertainty of pharmaceutical product
development, unexpected adverse events and/or adverse regulatory
action, possible required modifications to clinical trials and the
inability to provide information and institute safety mitigation
measures as required by the FDA or other regulatory authorities
from time to time, failure to properly conduct or manage the
company’s clinical trials and failure of clinical results to
support continued development or regulatory approvals, in which
case our clinical trials may be delayed or discontinued. More
information about the risks and uncertainties faced by Seattle
Genetics is contained under the caption “Risk Factors” included in
the company’s Annual Report on Form 10-K for the year ended
December 31, 2018 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, except as
required by law.
1 National Cancer Institute SEER. “Cancer Stat Facts: Cervix
Uteri Cancer.” Available at
https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed
March 2019.2 Global Cancer Statistics 2018: GLOBOCAN Estimates of
Incidence and Mortality Worldwide for 36 Cancers in 185 countries
https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.3
Miller et al., Gynecol Oncol 2008; 110:65.4 Bookman et al., Gynecol
Oncol 2000; 77:446.5 Garcia et al., Am J Clin Oncol 2007; 30:428.6
Muggia et al., J Clin Oncol 2009; 27:1069.7 Monk et al., J Clin
Oncol 2009; 27:1069.8 Santin et al., Genecol Oncol 2011; 122:495.9
Schellens, J Clin Oncol 35, 2017 (suppl; abstr 5514).10 Hollebecque
et al., J Clin Oncol 35, 2017 (suppl; abstr 6025).
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Media:Monique Greer(425) 527-4641mgreer@seagen.com
Investors:Peggy Pinkston(425) 527-4160ppinkston@seagen.com
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