- Data Featured in Late-Breaking Proffered
Paper Oral Presentation -
- Biologics License Application Submission
Planned to Support Accelerated Approval Pathway with the FDA -
Seattle Genetics, Inc. (Nasdaq:SGEN) and Genmab A/S (Nasdaq:
GMAB) 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 currently 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.”
“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.”
“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.”
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 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.
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.
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.
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.
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; 96:103 8
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/.
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Seattle Genetics Media: Monique Greer (425) 527-4641
mgreer@seagen.com
Investors: Peggy Pinkston (425) 527-4160
ppinkston@seagen.com
Genmab A/S Media: Marisol
Peron, Corporate Vice President, Communications & Investor
Relations +1 609 524 0065 mmp@genmab.com
Investors: Andrew Carlsen, Senior Director, Investor Relations
+45 3377 9558 acn@genmab.com
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