Genmab Announces Phase 3 Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
January 04 2021 - 2:00PM
Media Release COPENHAGEN, Denmark, Jan.
04, 2021
- Initiation of a global phase 3 trial for tisotumab
vedotin versus investigator’s choice chemotherapy in recurrent or
metastatic cervical cancer
Genmab A/S (Nasdaq: GMAB) announced today the initiation
of innovaTV 301 trial, a global phase 3 study to evaluate the
efficacy of tisotumab vedotin compared to chemotherapy in patients
with recurrent or metastatic cervical cancer who have received one
or two prior lines of systemic therapy. The innovaTV 301
trial is a global, randomized phase 3 trial in which tisotumab
vedotin will be compared with physician’s choice single agent
chemotherapy.
“Currently, there is no established standard of care for women
with recurrent or metastatic cervical cancer, who have disease
progression after first or second line of therapy. There is a need
for a novel, safe and effective treatment option that can improve
the clinical outcome for these patients,” said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab. “We look forward to the
innovaTV 301 trial which is designed to support potential
regulatory applications for marketing approval globally and serve
as a confirmatory trial for a potential accelerated approval in the
US for patients with metastatic or recurrent cervical cancer.”
About the innovaTV 301 TrialThe open label,
randomized, global, phase 3 trial of tisotumab vedotin versus
chemotherapy will enroll approximately 482 patients with recurrent
or metastatic cervical cancer who have received one or two prior
lines of systemic therapy for their recurrent or metastatic
disease. Eligible patients will be randomized to receive either
tisotumab vedotin 2.0 mg/kg every three weeks or investigator’s
choice of chemotherapy. The primary endpoint of the study is
overall survival. This global study will be sponsored and performed
by Seagen Inc. in collaboration with Genmab, European Network of
Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic
Oncology Group (GOG).
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 protein that can promote tumor growth,
angiogenesis and metastasis.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 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 ongoing clinical trials
as monotherapy in a range of solid tumors, including recurrent
and/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.
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.
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.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
This Media Release 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 Media Release 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.
References1 Van de Berg YW et al. Blood 2012;
119:924.2 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/.
Media Release no. 01CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 010421_i01_ innovaTV 301 study
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