Media Release
COPENHAGEN, Denmark and BOTHELL, Wash., 21
September 2020
- Data featured in late-breaking proffered paper oral
presentation
- Biologics license application submission planned to
support accelerated approval pathway with the FDA
Genmab A/S (Nasdaq: GMAB) and Seattle Genetics, Inc.
(Nasdaq: SGEN) today presented data from the innovaTV 204 pivotal
phase 2, single-arm clinical trial evaluating tisotumab vedotin as
monotherapy in patients with previously treated recurrent and/or
metastatic cervical cancer at the European Society for Medical
Oncology (ESMO) Virtual Congress 2020. Patients had
previously received a doublet chemotherapy and, if eligible,
bevacizumab as first-line therapy. Results from the trial showed a
24 percent confirmed objective response rate (ORR) by independent
central review 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. Tisotumab
vedotin is an investigational antibody-drug conjugate (ADC)
directed to tissue factor (TF), which is prevalent on solid tumors
including cervical cancer and can promote tumor growth,
angiogenesis and metastasis.1
Current 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.1-8
“Following resistance to or progression on first-line standard
of care therapy, there are limited treatment options for women with
metastatic cervical cancer,” said Robert L. Coleman, M.D., Chief
Scientific Officer for US Oncology Research and lead investigator
of the innovaTV 204 clinical trial. “The current treatment
approaches for this disease setting have low objective response
rates with poor outcomes. The results of the tisotumab vedotin
phase 2 clinical trial are encouraging as they demonstrate
clinically meaningful, durable responses with a manageable side
effect profile.”
“We are encouraged by the innovaTV 204 trial results, which
suggests that tisotumab vedotin as a monotherapy could potentially
become an important option for women with metastatic and or
recurrent cervical cancer,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab. “Seattle Genetics and Genmab are
committed to making a difference in the lives of cancer patients
and we look forward to working with the FDA with a goal to make
this potential treatment option available to women as quickly as
possible.”
“Tisotumab vedotin has demonstrated meaningful clinical activity
in patients with recurrent and/or metastatic cervical cancer for
whom there is a high unmet need for new therapies,” said Roger
Dansey, M.D., Chief Medical Officer at Seattle Genetics. “Based on
these results, we look forward to submitting a Biologics License
Application to the FDA under the accelerated approval pathway.”
Data presented at ESMO include the primary endpoint of confirmed
ORR as assessed by independent central review in 101 patients
treated with tisotumab vedotin in the trial. Secondary endpoints
included DOR, time to response, progression-free survival (PFS),
overall survival (OS), safety and tolerability.
Tisotumab Vedotin in Previously Treated Recurrent or
Metastatic Cervical Cancer: Results from the Phase 2 innovaTV
204/GOG-3023/ENGOT-cx6 Study (Abstract #3435,
late-breaking proffered paper oral presentation at 17:04 CET on
Monday, September 21, 2020)
Efficacy:
- The primary endpoint of ORR (complete response + partial
response) showed a 24 percent confirmed ORR [95% Confidence
Interval (CI): 15.9%-33.3%], including 7 patients (7 percent) with
a complete response and 17 patients (17 percent) with a partial
response.
- After a median follow-up of 10 months, the median DOR was 8.3
months (95% CI: 4.2, not reached).
- The median time to response was 1.4 months (range, 1.1-5.1),
with activity generally observed within the first two treatment
cycles.
- Subgroup analyses demonstrated that responses were generally
consistent across subgroups regardless of tumor histology, lines of
prior therapy, responses to prior systemic regimen, and doublet
chemotherapy with bevacizumab as first-line treatment.
- The median PFS was 4.2 months (95% CI: 3.0, 4.4) and the
six-month PFS rate was 30 percent (95% CI: 20.8, 40.1).
- The median OS was 12.1 months (95% CI: 9.6, 13.9) and the
six-month OS rate was 79 percent (95% CI: 69.3, 85.6).
Safety:
- The most common treatment-related adverse events (greater than
or equal to 20 percent) included alopecia (Grade 1/2 at 38
percent), epistaxis (nose bleeds, Grade 1/2 at 30 percent), nausea
(Grade 1/2 at 27 percent), conjunctivitis (Grade 1/2 at 26
percent), fatigue (Grade 1/2 at 24 percent, Grade 3 or higher at 2
percent) and dry eye (Grade 1/2 at 23 percent). Most
treatment-related adverse events were Grade 1 or 2 and no new
safety signals were reported. One death due to septic shock was
considered by the investigator to be related to therapy.
- Pre-specified adverse events of interest with tisotumab vedotin
treatment included ocular events, bleeding and peripheral
neuropathy. Ocular adverse events considered to be related to
therapy that occurred in patients were mostly mild to moderate
(Grade 1 at 25 percent, Grade 2 at 27 percent, Grade 3 at 2
percent) of which a majority of the events resolved (86 percent)
and were managed with an eye care plan. Bleeding events considered
to be related to therapy that occurred in patients were mostly mild
(Grade 1 at 34 percent, Grade 2 at 3 percent, Grade 3 at 2 percent)
of which a majority of the events resolved (90 percent). The most
common bleeding events included Grade 1 epistaxis (28 percent).
Peripheral neuropathy events considered to be related to therapy
were mostly mild to moderate (Grade 1 at 17 percent, Grade 2 at 9
percent, Grade 3 at 7 percent) and managed with dose modifications.
Resolution of peripheral neuropathy was limited by follow-up
period.
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.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
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 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
and/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 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 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 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 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 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 the following 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, Kesimpta®
(subcutaneous ofatumumab, under agreement with Novartis AG), for
the treatment of adults with relapsing forms of multiple sclerosis
in the U.S. 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. The first approved Genmab created therapy,
Arzerra® (ofatumumab, under agreement with Novartis AG), approved
for the treatment of certain chronic lymphocytic leukemia
indications, is available in Japan and is also available in other
territories via compassionate use or oncology access programs.
Daratumumab is in clinical development by Janssen for the treatment
of additional multiple myeloma indications, other blood cancers and
amyloidosis. 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.
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
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.seattlegenetics.com and follow @SeattleGenetics on Twitter.
CONTACTS:
Genmab A/SMedia: Marisol Peron, Corporate Vice
President, Communications & Investor Relations +1 609 524
0065mmp@genmab.com
Investors: Andrew Carlsen, Senior Director, Investor
Relations+45 3377 9558 acn@genmab.com
Seattle GeneticsMedia:Monique Greer(425)
527-4641mgreer@seagen.com
Investors:Peggy Pinkston(425) 527-4160ppinkston@seagen.com
Genmab Forward Looking Statement 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.
Seattle Genetics Forward Looking Statement
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to plans to submit a
Biologics License Application (BLA) to FDA under FDA’s Accelerated
Approval program based on the results of the innovaTV 204, 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 the possibility of delays in the submission of a
BLA to the FDA, that the data from innovaTV 204 may not be
sufficient to support accelerated approval of tisotumab vedotin,
the difficulty and uncertainty of pharmaceutical product
development, the risk of adverse events or safety signals, the
inability to show sufficient activity in current and future
clinical trials and the possibility of adverse regulatory actions.
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
June 30, 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; 96:1038 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/.
Media Release no. 12CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
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