-- Tisotumab Vedotin in Combination with Carboplatin Showed Encouraging,
Durable Anti-Tumor Activity as First-Line Treatment
-- Tisotumab Vedotin in Combination with Pembrolizumab Showed Encouraging,
Durable Anti-Tumor Activity in Previously Treated Patients
COPENHAGEN, Denmark, and BOTHELL, Wash.; September 19, 2021 -
(Nasdaq: GMAB) and Seagen Inc.
(Nasdaq: SGEN) today presented interim data from two cohorts of the
Phase 1b/2 innovaTV 205 multi-cohort, open-label trial of tisotumab
vedotin in recurrent or metastatic cervical cancer at the European
Society for Medical Oncology (ESMO) Virtual Congress 2021 as part
of a featured mini oral presentation. Initial results from these
two dose expansion cohorts of the study showed encouraging and
durable anti-tumor activity with tisotumab vedotin in combination
with carboplatin (Cohort D) as first-line therapy for patients with
advanced cervical cancer who had not received prior systemic
therapy, with a 55% objective response rate (ORR) and with
tisotumab vedotin in combination with pembrolizumab (Cohort F) for
patients with advanced cervical cancer who experienced disease
progression after 1-2 lines of prior systemic therapy, with a 38%
ORR. Both combinations demonstrated a manageable and acceptable
safety profile, with no new safety signals identified.
"For patients diagnosed with recurrent or metastatic cervical
cancer, there is a need for additional treatment options in the
first-, second- and third-line settings," said Ignace B. Vergote,
M.D., Ph.D., co-founder of European Network of Gynaecological
Oncological Trial groups (ENGOT), and lead investigator on the
innovaTV 205/ENGOT-cx8/GOG-3024 clinical trial. "Interim results
from the innovaTV 205 study show the potential for tisotumab
vedotin to treat these patients, with encouraging response rates in
combination with carboplatin and also in combination with
"We are pleased to share the initial results from the innovaTV
205 study, as these data build upon our understanding of the
potential for tisotumab vedotin as a combination therapy in first-
and second-line treatment of recurrent or metastatic cervical
cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer,
Genmab. "We recognize the need for new therapies for patients with
cervical cancer globally and are committed to advancing the
tisotumab vedotin development program."
"As we advance our clinical development program for tisotumab
vedotin into earlier lines of therapy in cervical cancer, we're
encouraged by these interim results of the combination cohorts with
tisotumab vedotin, " said Roger Dansey, M.D., Chief Medical
Officer, Seagen. "Based on these results from the innovaTV 205
study, we also plan to evaluate tisotumab vedotin further in
various combinations in first-line metastatic or recurrent cervical
Tisotumab Vedotin (TV) + Carboplatin (Carbo) in First-line (1L)
or + Pembrolizumab (Pembro) in Previously Treated (2L/3L) Recurrent
or Metastatic Cervical Cancer (r/mCC): Interim Results of
ENGOT-cx8/GOG-3024/innovaTV 205 Study (Presentation #723MO, mini
oral presentation on Sunday, September 19)
1L TV + Carbo Dose Expansion Cohort Interim Results
Within this cohort, recurrent or metastatic cervical cancer
patients who had not received any prior systemic therapy were given
the recommended Phase 2 dose of tisotumab vedotin 2.0 mg/kg plus
carboplatin AUC 5 Q3W.
-- The primary endpoint of ORR was 55% (n= 18/33 patients), with four
patients achieving complete responses and 14 patients achieving partial
-- Median time to response was 1.4 months (range 1.1-4.4), with median
follow up of 7.9 months and median duration of response of 8.3 months
(95% CI: 4.2-NR).
-- Median progression-free survival (PFS) was 9.5 months (95% CI: 4.0-NR).
-- Grade >=3 adverse events (AE) occurred in 78.8% of patients (n=26/33),
with 57.6% (n=19/33) of patients experiencing Grade >=3 AEs related to
treatment with tisotumab vedotin.
-- Adverse events of special interest (AESI) included ocular events (Grade
1-2: 57.6%; Grade >=3: 9.1%), bleeding (Grade 1-2: 51.5%; Grade >=3:
6.1%) and peripheral neuropathy (Grade 1-2: 48.5; Grade >=3: 12.1%).
2L/3L TV + Pembro Dose Expansion Cohort Results Interim
Within this cohort, recurrent or metastatic cervical cancer
patients who had received 1-2 prior systemic therapies were given
the recommended Phase 2 dose of tisotumab vedotin 2.0 mg/kg plus
pembrolizumab 200 mg Q3W.
-- The primary endpoint of ORR was 38% (n=13/34 patients), with two patients
achieving complete responses and 11 patients achieving partial responses.
-- Median time to response was 1.4 months (range 1.3-5.8), with median
follow-up of 13.0 months and a median duration of response of 13.8 months
(95% CI: 2.8-NR).
-- Median PFS was 5.6 months (95% CI: 2.7-13.7).
-- Grade >=3 AEs occurred in 74.3% of patients (n=26/35), with 45.7%
(n=16/35) of patients experiencing Grade >=3 AEs related to treatment
with tisotumab vedotin.
-- AESI included ocular events (Grade 1-2: 51.4%; Grade >=3: 2.9%), bleeding
(Grade 1-2: 57.1%; Grade >=3: 8.6%) and peripheral neuropathy (Grade 1-2:
37.1%; Grade >=3: 2.9%), with one patient experiencing a Grade 4 bleeding
Additionally, Genmab and Seagen presented data from
dose-escalation cohorts of the innovaTV 205 study at the 2021
International Gynecologic Cancer Society (IGCS) Annual Meeting held
August 30 -- September 2, 2021.
About Cervical Cancer
Cervical cancer originates in the cells lining the cervix. In
2021, an estimated 14,480 new cases of invasive cervical cancer
will be diagnosed in the U.S., and 4,290 women will die from the
disease.(1) 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 are in the developing
world.(2) 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.(3) (,) (4) (,) (5) (,) (6)
(,) (7) (,) (8) (,) (9) (,) (10)
About the innovaTV 205 Trial
The innovaTV 205 trial (also known as ENGOT-cx8/GOG-3024) is a
Phase 1b/2 open-label, multi-center trial of tisotumab vedotin
monotherapy and in combination with bevacizumab, pembrolizumab, or
carboplatin in patients with recurrent or metastatic cervical
cancer. The study consists of two parts: dose escalation (Cohorts
A, B, and C) and dose expansion (Cohorts D, E, F and G). Patients
enrolled in the dose escalation cohorts have progressed during or
after standard of care therapy or are intolerant or ineligible to
receive standard of care treatments. The primary objective is to
identify and establish the maximum tolerated dose and Recommended
Phase 2 Dose (RP2D) of tisotumab vedotin as combination therapy.
Within the dose expansion cohorts, patients with recurrent or
metastatic cervical cancer who have not previously received prior
systemic therapy are treated in Cohorts D and E, with patients who
have progressed on or after standard of care treatments evaluated
in Cohorts F and G.
For more information about the innovaTV 205 clinical trial and
the study collaborators, visit here
, and to learn more about other clinical trials with tisotumab
vedotin, visit clinicaltrials.gov
About Tisotumab Vedotin
Tisotumab vedotin is an 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 programmed
cell death. In cancer biology, tissue factor is a cell-surface
protein and is associated with tumor growth, angiogenesis,
metastasis and poor prognosis.(11) Tissue factor was selected as a
target for an ADC approach based on its increased levels of
expression on multiple solid tumors and its rapid
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. More
information about the innovaTV 301 clinical trial, including
enrolling sites, is available here
. 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
Additional clinical studies for tisotumab vedotin include Phase
2 studies in second-/third-line recurrent or metastatic cervical
cancer as monotherapy (innovaTV 204), a Phase 2 study in
first-/second-line recurrent or metastatic cervical cancer as
monotherapy or in combination with other agents (innovaTV 205) and
additional studies in various solid tumors.
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
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
About the Genmab and Seagen Collaboration
Tisotumab vedotin is being co-developed by Genmab and Seagen,
under an agreement in which the companies share costs and profits
for the product on a 50:50 basis.
Genmab Forward Looking Statements
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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) and
Seagen Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of tisotumab vedotin including its efficacy, safety and
therapeutic uses, the clinical development program for tisotumab
vedotin and the potential for the innovaTV 301 trial to support
global registrations. 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
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 Seagen is contained under the
caption "Risk Factors" included in the Company's Quarterly Report
on Form 10-Q for the quarter ended June 30, 2021 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.
Marisol Peron, Senior Vice President, Global Investor Relations
T: +1 609 524 0065; E: email@example.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: firstname.lastname@example.org
Vice President, Corporate Communications
Senior Vice President, Investor Relations
(1) Cancer Stat Facts: Cervical Cancer. National Cancer
September 13, 2021.
(2) Bray et al., CA Cancer J Clin 2018; 0:1-31.
(3) Miller et al., Gynecol Oncol 2008; 110:65.
(4) Santin et al., Gynecol Oncol 2011; 122:495.
(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.
(11) Rondon et al. Semin Thromb Hemost 2019; 45:396--412.
Media Release no. 10
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Kalvebod Brygge 43
1560 Copenhagen V
-- 190921_i10_ESMO TV Data Release
(END) Dow Jones Newswires
September 19, 2021 11:30 ET (15:30 GMT)
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