-Phase 2 innovaTV 204 Trial Designed to Support Potential Accelerated
Approval Pathway in U.S.-
BOTHELL, Wash.–(BUSINESS WIRE)–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).
Contacts
Media:
Monique Greer
(425) 527-4641
mgreer@seagen.com
Investors:
Peggy Pinkston
(425) 527-4160
ppinkston@seagen.com