Company Announcement
- Genmab and Seattle Genetics plan to discuss the results
with the U.S. Food and Drug Administration (U.S. FDA)
- Full data to be presented at an upcoming medical
meeting
Copenhagen, Denmark; June 29, 2020 –
Genmab A/S (Nasdaq: GMAB) today announced very favorable
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 in
collaboration with Seattle Genetics.
“After treatment with first-line chemotherapy regimens, there is
a high unmet need for new effective and tolerable treatment options
for women with advanced cervical cancer, regardless of biomarkers
and histology,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. “These promising topline data from innovaTV 204
will be the basis of further engagement with the U.S. FDA as we
continue to progress and expand our tisotumab vedotin development
program in solid tumors with our partner.”
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 TrialThe 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 bevacizumab if
eligible per local standards. Additionally, patients were eligible
if they had received up to two prior lines of therapy in the
metastatic setting. In the study operationalized by Genmab, 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 Seattle
Genetics Inc., 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 Cervical CancerCervical 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.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.
About Tisotumab VedotinTisotumab 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 Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company is the creator of
three approved antibodies: DARZALEX® (daratumumab, under agreement
with Janssen Biotech, Inc.) for the treatment of certain multiple
myeloma indications in territories including the U.S., Europe and
Japan, Arzerra® (ofatumumab, under agreement with Novartis AG), for
the treatment of certain chronic lymphocytic leukemia indications
in the U.S., Japan and certain other territories and TEPEZZA™
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, known as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S.,
has been approved in the U.S. and Europe for the treatment of adult
patients with certain multiple myeloma indications. Daratumumab is
in clinical development by Janssen for the treatment of additional
multiple myeloma indications, other blood cancers and amyloidosis.
A subcutaneous formulation of ofatumumab is in development by
Novartis for the treatment of relapsing multiple sclerosis. Genmab
also has a broad clinical and pre-clinical product pipeline.
Genmab's technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody® platform for
generation of bispecific antibodies, the HexaBody® platform, which
creates effector function enhanced antibodies, the HexElect®
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency and the DuoHexaBody® platform, which enhances the potential
potency of bispecific antibodies through hexamerization. The
company intends to leverage these technologies to create
opportunities for full or co-ownership of future products. Genmab
has alliances with top tier pharmaceutical and biotechnology
companies. Genmab is headquartered in Copenhagen, Denmark with
sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
Tokyo, Japan.
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 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® is a trademark of
Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO™ are
trademarks of Janssen Pharmaceutica NV. TEPEZZA™ is a trademark of
Horizon Therapeutics plc.
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; 96:1038 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/.
Company Announcement no. 26CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 290620_CA26_innovaTV 204 Topline
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