- Full Data to be Presented at an Upcoming
Medical Meeting -
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive
topline results from the phase 2 single-arm clinical trial known as
innovaTV 204 evaluating tisotumab vedotin administered every three
weeks for the treatment of patients who have relapsed or progressed
on or after prior treatment for recurrent or metastatic cervical
cancer. Results from the trial showed a 24 percent confirmed
objective response rate (ORR) by independent central review [95%
Confidence Interval: 15.9%-33.3%] with a median duration of
response (DOR) of 8.3 months. The most common treatment-related
adverse events (greater than or equal to 20 percent) included
alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue
and dry eye. The data will be submitted for presentation at an
upcoming medical meeting.
Tisotumab vedotin is an investigational antibody-drug conjugate
(ADC) directed to tissue factor, which is expressed on cervical
cancer and can promote tumor growth, angiogenesis and metastases.1
Standard therapies for previously treated recurrent and/or
metastatic cervical cancer generally result in limited objective
response rates of typically less than 15 percent with median
overall survival ranging from 6.0 to 9.4 months, in an all-comers
population.1-8 Tisotumab vedotin is being developed by Seattle
Genetics in collaboration with Genmab.
“Available therapies upon progression after first line
chemotherapy in recurrent or metastatic cervical cancer are
limited, and there is a significant unmet need for new treatment
options,” said Roger Dansey, M.D., Chief Medical Officer at Seattle
Genetics. “Tisotumab vedotin has demonstrated clinically meaningful
and durable objective responses with a manageable safety profile,
and we look forward to discussing with the FDA the potential
submission of a Biologics License Application to support an
accelerated approval.”
Cervical cancer originates in the cells lining the cervix. Over
13,500 women are expected to be diagnosed with cervical cancer in
the U.S. in 2020, with approximately 4,200 deaths.9 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.10 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 often recurs or becomes metastatic.
Additional clinical trials of tisotumab vedotin are currently
enrolling patients, including in combination with pembrolizumab,
carboplatin or bevacizumab, and with a weekly dosing schedule in
patients with locally advanced or metastatic cervical cancer.
Tisotumab vedotin is also being evaluated in other tissue factor
expressing tumor types, including ovarian and other solid
tumors.
About innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04 or innovaTV
204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global,
multicenter study of tisotumab vedotin for patients with recurrent
or metastatic cervical cancer who were previously treated with
doublet chemotherapy with or without bevacizumab. Additionally,
patients were eligible if they had received up to two prior lines
of therapy in the metastatic setting. In the study, 101 patients
were treated with tisotumab vedotin at multiple centers in the U.S.
and Europe. The primary endpoint of the trial was confirmed
objective response rate per Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 as assessed by independent central review. Key
secondary endpoints included duration of response, progression-free
survival, overall survival, safety and tolerability.
The study was conducted in collaboration with European Network
of Gynaecological Oncological Trial Groups (ENGOT) and Gynecologic
Oncology Group (GOG). For more information about the phase 2
innovaTV 204 clinical trial and other clinical trials with
tisotumab vedotin, please visit www.clinicaltrials.gov.
About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate
(ADC) composed of Genmab’s fully human monoclonal antibody specific
for tissue factor and Seattle Genetics’ ADC technology that
utilizes a protease-cleavable linker that covalently attaches the
microtubule-disrupting agent monomethyl auristatin E (MMAE) to the
antibody and releases it upon internalization, inducing target cell
death. In cancer biology, tissue factor is a protein that can
promote tumor growth, angiogenesis and metastases.1 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 Genmab and Seattle
Genetics, under an agreement in which the companies share all costs
and profits for the product on a 50:50 basis.
Tisotumab vedotin is being evaluated in ongoing clinical trials
as monotherapy in a range of solid tumors, including recurrent
and/or metastatic cervical cancer, ovarian cancer and in
combination with other commonly used therapies in recurrent or
metastatic cervical cancer. These trials are evaluating tisotumab
vedotin on a weekly or every three weeks dosing schedule.
About Seattle Genetics
Seattle Genetics, Inc. is a global biotechnology company that
discovers, develops and commercializes transformative cancer
medicines to make a meaningful difference in people’s lives.
ADCETRIS® (brentuximab vedotin) and PADCEVTM (enfortumab
vedotin-ejfv) use the company’s industry-leading antibody-drug
conjugate (ADC) technology. ADCETRIS is approved in certain
CD30-expressing lymphomas, and PADCEV is approved in certain
metastatic urothelial cancers. TUKYSATM (tucatinib), a small
molecule tyrosine kinase inhibitor, is approved in certain
HER2-positive metastatic breast cancers. The company is
headquartered in the Seattle, Washington area, with locations in
California, Switzerland and the European Union. 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 potential
submission of a BLA to the FDA under the FDA’s accelerated approval
program and the potential for regulatory approval of tisotumab
vedotin based on the innovaTV 204 trial; the therapeutic potential
of tisotumab vedotin, its possible benefits and uses, including as
monotherapy or in combination with other agents, and in other tumor
types or with a weekly dosing regimen, and the tisotumab vedotin
future development program. 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 possibility that the data from innovaTV 204
may not be sufficient to support accelerated approval; the
possibility of impediments or delays in the submission of a
potential BLA to the FDA; the risk of adverse events, including the
potential for newly-emerging safety signals; delays, setbacks or
failures in clinical development activities for a variety of
reasons, including the difficulty and uncertainty of pharmaceutical
product development, adverse regulatory action, possible required
modifications to clinical trials, failure to properly conduct or
manage clinical trials and failure of clinical results to support
continued development or regulatory approvals. 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 March
31, 2020 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.
References:
1 Van de Berg YW et al. Blood 2012;119:924. 2 Miller et al.,
Gynecol Oncol 2008; 110:65. 3 Bookman et al., Gynecol Oncol 2000;
77:446. 4 Garcia et al., Am J Clin Oncol 2007; 30:428. 5 Monk et
al., J Clin Oncol 2009; 27:1069. 6 Santin et al., Gynecol Oncol
2011; 122:495. 7 Schilder et al., Gynecol Oncol 2005; 96:103 8
Chung HC et al. J Clin Oncol 2019; 37:1470. 9 National Cancer
Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.” Available
at https://seer.cancer.gov/statfacts/html/cervix.html. Last
accessed April 2020. 10 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/.
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version on businesswire.com: https://www.businesswire.com/news/home/20200629005802/en/
Seattle Genetics Media: Monique Greer, 425-527-4641
mgreer@seagen.com
Investors: Peggy Pinkston, 425-527-4160 ppinkston@seagen.com
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