- Submission Based on Positive Pivotal innovaTV
204 Trial Results Presented at the European Society of Medical
Oncology Virtual Congress 2020 -
Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today
announced the submission of a Biologics License Application (BLA)
to the U.S. Food and Drug Administration (FDA) seeking accelerated
approval for tisotumab vedotin. This BLA requests FDA approval of
tisotumab vedotin for the treatment of patients with recurrent or
metastatic cervical cancer with disease progression on or after
chemotherapy. The submission is based on the results of the
innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating
tisotumab vedotin as monotherapy in this setting. The topline
results from the phase 2 study were announced in June 2020 and data
were presented at the European Society for Medical Oncology (ESMO)
Virtual Congress 2020. Tisotumab vedotin is an investigational
antibody-drug conjugate (ADC) directed to tissue factor (TF), a
cell-surface protein expressed on multiple solid tumors including
cervical cancer and is associated with tumor growth, angiogenesis,
metastasis and poor prognosis.1
“In the pivotal phase 2 study, tisotumab vedotin induced
clinically meaningful and durable responses in this difficult to
treat cervical cancer patient population, with a manageable and
tolerable safety profile. Today’s submission marks an important
milestone for tisotumab vedotin and a potential advance for
patients with recurrent or metastatic cervical cancer for whom
there is a high unmet need for effective new therapies,” said Roger
Dansey, M.D., Chief Medical Officer at Seagen. “We look forward to
working with the FDA on the review of the application.”
“This BLA submission is an important step toward our goal of
improving the lives of women with recurrent or metastatic cervical
cancer. I would like to thank the patients, nurses, physicians and
researchers who participated in the innovaTV 204 trial, which is
the basis of this submission,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab. “We believe, if approved, tisotumab
vedotin as monotherapy has the potential to become an important
treatment option for women with recurrent or metastatic cervical
cancer, who have disease progression on or after chemotherapy.”
About Cervical Cancer
Cervical cancer originates in the cells lining the cervix. Over
13,500 women are expected to be diagnosed with invasive cervical
cancer in the U.S. in 2020, with approximately 4,200 deaths.2
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.3 Routine
medical examinations and human papillomavirus (HPV) vaccines 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. Current therapies
for previously treated recurrent 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.4-10
About the 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 recurrent or 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 by Genmab in collaboration with Seagen,
European Network of Gynaecological Oncological Trial Groups (ENGOT)
and the Gynecologic Oncology Group (GOG) Foundation. 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 Seagen’s 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 cell-surface protein
and associated with tumor growth, angiogenesis, metastasis and poor
prognosis.1 Based on its elevated expression in multiple 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 Seagen, 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 a global phase 3,
randomized clinical trial called innovaTV 301 versus investigator’s
choice of chemotherapy in recurrent or metastatic cervical cancer.
The primary endpoint is overall survival and secondary endpoints
include progression-free survival, duration of response, objective
response rate, safety and tolerability. Enrollment is ongoing and
the study is intended to support global registrations. In addition,
tisotumab vedotin is being evaluated in ongoing clinical trials as
monotherapy in recurrent or metastatic cervical cancer, ovarian
cancer, and other solid tumors and in combination with commonly
used therapies in recurrent or metastatic cervical cancer. These
trials are evaluating tisotumab vedotin on a weekly or every
three-week dosing schedule. More information about the innovaTV 301
clinical trial, including enrolling sites, as well as other ongoing
clinical trials is available at www.clinicaltrials.gov.
About Seagen
Seagen 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 PADCEV® (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. TUKYSA®
(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.seagen.com and
follow @SeagenGlobal on Twitter.
About Genmab
Genmab is an international biotechnology company with a core
purpose to improve the lives of patients with cancer. Founded in
1999, Genmab is the creator of multiple approved antibody
therapeutics that are marketed by its partners. The company aims to
create, develop and commercialize differentiated therapies by
leveraging next-generation antibody technologies, expertise in
antibody biology, translational research and data sciences and
strategic partnerships. To create novel therapies, Genmab utilizes
its next-generation antibody technologies, which are the result of
its collaborative company culture and a deep passion for
innovation. Genmab’s proprietary pipeline consists of modified
antibody candidates, including bispecific T-cell engagers and
next-generation immune checkpoint modulators, effector function
enhanced antibodies and antibody-drug conjugates. The company is
headquartered in Copenhagen, Denmark with locations in Utrecht, the
Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more
information, please visit Genmab.com.
Seagen Forward-Looking Statements
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
potential FDA approval of tisotumab vedotin for the treatment of
patients with recurrent or metastatic cervical cancer with disease
progression on or after chemotherapy based on the results of the
innovaTV 204 trial, clinical trials of tisotumab vedotin and its
therapeutic potential. 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 Biologics License Application submission based
on the innovaTV 204 trial may not be accepted for filing by, or
ultimately approved by, the FDA in a timely manner or at all or
with the requested label; that subsequent clinical trials may fail
to establish sufficient efficacy; that adverse events or safety
signals may occur; and that adverse regulatory actions may occur as
tisotumab vedotin advances in clinical trials even after promising
results in earlier clinical trials. More information about the
risks and uncertainties faced by Seagen is contained under the
caption “Risk Factors” included in the Company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2020 and the
Company’s Current Report on Form 8-K dated December 30, 2020 filed
with the Securities and Exchange Commission. Seagen 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.
Genmab Forward-Looking Statements
This Company Announcement contains forward-looking statements.
The words “believe,” “expect,” “anticipate,” “intend” and “plan”
and similar expressions identify forward-looking statements. Actual
results or performance may differ materially from any future
results or performance expressed or implied by such statements. The
important factors that could cause our actual results or
performance to differ materially include, among others, risks
associated with pre-clinical and clinical development of products,
uncertainties related to the outcome and conduct of clinical trials
including unforeseen safety issues, uncertainties related to
product manufacturing, the lack of market acceptance of our
products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and
proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our
products or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward-looking statements in this Company
Announcement nor to confirm such statements to reflect subsequent
events or circumstances after the date made or in relation to
actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks:
Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the
Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination
with the DuoBody logo®; HexaBody®; HexaBody in combination with the
HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and
Kesimpta® are trademarks of Novartis AG or its affiliates.
DARZALEX® and DARZALEX FASPRO® are trademarks of Janssen
Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics
plc.
References:
1 Rondon et al. Semin Thromb Hemost 2019;45:396–412. 2 National
Cancer Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.”
Available at https://seer.cancer.gov/statfacts/html/cervix.html.
Last accessed April 2020. 3 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/.
4 Miller et al., Gynecol Oncol 2008; 110:65. 5 Bookman et al.,
Gynecol Oncol 2000; 77:446. 6 Garcia et al., Am J Clin Oncol 2007;
30:428. 7 Monk et al., J Clin Oncol 2009; 27:1069. 8 Santin et al.,
Gynecol Oncol 2011; 122:495. 9 Schilder et al., Gynecol Oncol 2005;
96:103 10 Chung HC et al. J Clin Oncol 2019; 37:1470.
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version on businesswire.com: https://www.businesswire.com/news/home/20210210005913/en/
Seagen Media and Investors: Peggy Pinkston (425) 527-4160
ppinkston@seagen.com
Genmab A/S Media: Marisol Peron, Senior Vice President,
Global Investor Relations & Communications +1 609 524 0065
mmp@genmab.com
Investors: Andrew Carlsen, Senior Director, Head of Investor
Relations +45 3377 9558 acn@genmab.com
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