- FDA action date is Oct 10, 2021
- BLA submission supported by positive pivotal innovaTV 204
trial results presented at the European Society of Medical Oncology
Virtual Congress 2020
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN)
today announced that the U.S. Food and Drug Administration (FDA)
has accepted for Priority Review the Biologics License Application
(BLA) 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. Under the Prescription Drug
User Fee Act (PDUFA), the FDA has set a target action date of Oct
10, 2021. 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
“We are pleased that the tisotumab vedotin BLA has been accepted
with Priority Review by the FDA as there is an unmet need for
effective therapies for women with recurrent or metastatic cervical
cancer, who have disease progression on or after chemotherapy,”
said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
“This is an important milestone for Genmab as it brings us closer
to our goal of bringing differentiated therapies to patients and
transforming cancer treatment.”
The FDA’s filing of the tisotumab vedotin BLA with Priority
Review marks an important step forward for this ADC as a potential
treatment for patients with recurrent or metastatic cervical
cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen.
“We are collaborating closely with the FDA throughout the review
process to make this important therapy available to patients.”
The BLA for tisotumab vedotin was submitted in February 2021.
The submission is based on the results of the innovaTV 204 pivotal
phase 2 single-arm clinical trial evaluating tisotumab vedotin as
monotherapy in patients with previously treated recurrent or
metastatic cervical cancer. These data were presented at the
European Society for Medical Oncology (ESMO) Virtual Congress
2020.
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 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.
About Seagen Seagen is a global biotechnology company
that discovers, develops and commercializes transformative cancer
medicines to make a meaningful difference in people’s lives. Seagen
is headquartered in the Seattle, Washington area, and has locations
in California, Canada, Switzerland and the European Union. For more
information on our marketed products and robust pipeline, visit
www.seagen.com and follow @SeagenGlobal on Twitter.
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®. Kesimpta® is
a trademark of Novartis AG or its affiliates. DARZALEX® and
DARZALEX FASPRO® are trademarks of Johnson & Johnson. TEPEZZA®
is a trademark of Horizon Therapeutics Ireland DAC.
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, the
timing of any potential FDA approval and the therapeutic potential
of tisotumab vedotin. 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
without limitation the possibility that the Biologics License
Application submission based on the innovaTV 204 trial may not be
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.
More information about the risks and uncertainties faced by Seagen
is contained under the caption “Risk Factors” included in the
Company’s Annual Report on Form 10-K for the year ended December
31, 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.
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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Genmab A/S: Marisol Peron, Senior Vice President, Global
Investor Relations & Communications T: +1 609 524 0065; E:
mmp@genmab.com
For Investor Relations: Andrew Carlsen, Vice President,
Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com
Seagen: Media and Investors: Peggy Pinkston, Senior Vice
President, Investor Relations (425) 527-4160
ppinkston@seagen.com
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