– Trial results to be submitted for
presentation at upcoming medical meeting –
TOKYO and BOTHELL,
Wash., Sept. 22, 2023 /PRNewswire/ -- Astellas
Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc.
(Nasdaq: SGEN) today announced positive topline results from the
Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for
PADCEV® (enfortumab vedotin-ejfv) in combination with
KEYTRUDA® (pembrolizumab) versus chemotherapy in
patients with previously untreated locally advanced or metastatic
urothelial cancer (la/mUC), a form of bladder cancer that has
spread to surrounding organs or muscles, or other parts of the
body. The EV-302 trial enrolled patients with previously untreated
la/mUC who were eligible for cisplatin- or
carboplatin-containing chemotherapy regardless of PD-L1
status.
The EV-302 study met its dual primary endpoints of overall
survival (OS) and progression-free survival (PFS), compared to
chemotherapy. An Independent Data Monitoring Committee determined
that OS crossed the pre-specified efficacy boundary at interim
analysis. The safety results of the combination are consistent with
those of enfortumab vedotin in combination with pembrolizumab
previously reported in cisplatin-ineligible patients with
la/mUC.
Please see Important Safety Information at the end of this press
release, including BOXED WARNING for PADCEV (enfortumab
vedotin-ejfv).
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of
Oncology Development, Astellas
"We are thrilled that the topline results of the EV-302 study
demonstrated that the combination of enfortumab vedotin and
pembrolizumab improved the dual primary endpoints of OS and PFS.
Patients living with metastatic urothelial cancer are in dire need
of additional treatment options and this combination has the
potential to advance the standard of care. We are extremely
grateful to all of the patients who participated in this
trial."
Roger Dansey, M.D., President,
Research and Development, Seagen
"This study has the potential to be practice changing and offer
a new standard of care for first-line metastatic bladder cancer. We
look forward to presenting the results at an upcoming medical
conference and discussing with regulators in order to get this
medicine to patients as soon as possible."
Thomas Powles, M.R.C.P., M.D.,
Professor of Genitourinary Oncology at Queen Mary University
of London; Director, Barts Cancer
Center, London; EV-302 Primary
Investigator
"Over two hundred thousand deaths from urothelial cancer are
reported worldwide annually, making it a major cause of morbidity
and mortality. The topline results from EV-302 are encouraging for
patients with advanced-stage urothelial cancer, which is aggressive
and associated with devastating outcomes."
The EV-302 trial is an open-label, randomized, controlled Phase
3 study, evaluating enfortumab vedotin in combination with
pembrolizumab versus chemotherapy in patients with previously
untreated la/mUC. In this study, patients were randomized to
receive either enfortumab vedotin in combination with pembrolizumab
or chemotherapy. The dual primary endpoints of this trial are OS
and PFS per RECIST v1.1 by blinded independent central review
(BICR). Full details will be reported at an upcoming scientific
congress.
The EV-302 trial is intended to serve as the basis for global
submissions and as the confirmatory trial for the U.S. accelerated
approval of this combination. In April
2023, the U.S. Food and Drug Administration (FDA) granted an
accelerated approval to PADCEV in combination with KEYTRUDA for the
treatment of adult patients with la/mUC who are not eligible to
receive cisplatin-containing chemotherapy based on the results from
the EV-103 trial. The trial is part of an extensive program
evaluating this combination in multiple stages of urothelial
cancer.
About Bladder and Urothelial Cancer
- Urothelial cancer, or bladder cancer, begins in the urothelial
cells, which line the urethra, bladder, ureters, renal pelvis, and
some other organs.1
- If bladder cancer has spread to surrounding organs or muscles,
it is called locally advanced disease. If the cancer has spread to
other parts of the body, it is called metastatic disease.
2
- Globally, approximately 573,000 new cases of bladder cancer and
212,000 deaths are reported annually.3
- It is estimated that approximately 82,290 people in the U.S.
will be diagnosed with bladder cancer in 2023.4
- It is estimated that approximately 200,000 people in
Europe and 24,000 people in
Japan are diagnosed with bladder
cancer annually. 5,6
- Urothelial cancer accounts for 90% of all bladder cancers and
can also be found in the renal pelvis, ureter, and
urethra.2
- Approximately 12% of cases are locally advanced or
metastatic urothelial cancer at diagnosis.7
Ongoing Investigational Trials
The EV-302 trial (NCT04223856) is an open-label, randomized,
controlled Phase 3 study, evaluating the impact of treatment with
enfortumab vedotin in combination with pembrolizumab versus
chemotherapy in patients with previously untreated locally advanced
or metastatic urothelial cancer (la/mUC) who were eligible for
cisplatin- or carboplatin-containing chemotherapy regardless of
PD-L1 status.
The EV-103 trial (NCT03288545) is an ongoing,
multi-cohort, open-label, multicenter Phase 1b/2 study investigating
enfortumab vedotin alone or in combination with
pembrolizumab and/or chemotherapy in first- or second-line settings
in patients with la/mUC and in patients with muscle-invasive
bladder cancer (MIBC).
Enfortumab vedotin in combination with pembrolizumab is being
investigated in an extensive program in multiple stages of
urothelial cancer, including two Phase 3 clinical trials in MIBC in
EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303
(NCT03924895, also known as KEYNOTE-905). The use of enfortumab
vedotin in combination with pembrolizumab in second-line urothelial
cancer and in MIBC has not been proven safe or effective.
About PADCEV® (enfortumab vedotin-ejfv)
PADCEV (enfortumab vedotin-ejfv) is a first-in-class
antibody-drug conjugate (ADC) that is directed against Nectin-4, a
protein located on the surface of cells and highly expressed in
bladder cancer.8 Nonclinical data suggest the
anticancer activity of PADCEV is due to its binding to
Nectin-4-expressing cells, followed by the internalization and
release of the anti-tumor agent monomethyl auristatin E (MMAE) into
the cell, which result in the cell not reproducing (cell cycle
arrest) and in programmed cell death (apoptosis).9
PADCEV (enfortumab vedotin-ejfv) U.S. Indication &
Important Safety Information
BOXED WARNING: SERIOUS SKIN REACTIONS
- PADCEV can cause severe and fatal cutaneous adverse reactions
including Stevens-Johnson syndrome
(SJS) and Toxic Epidermal Necrolysis (TEN), which occurred
predominantly during the first cycle of treatment, but may occur
later.
- Closely monitor patients for skin reactions.
- Immediately withhold PADCEV and consider referral for
specialized care for suspected SJS or TEN or severe skin
reactions.
- Permanently discontinue PADCEV in patients with confirmed SJS
or TEN; or Grade 4 or recurrent Grade 3 skin reactions.
Indication
PADCEV®, as a single agent, is indicated for the
treatment of adult patients with locally advanced or metastatic
urothelial cancer (mUC) who:
- have previously received a programmed death receptor-1 (PD-1)
or programmed death-ligand 1 (PD-L1) inhibitor and
platinum-containing chemotherapy, or
- are ineligible for cisplatin-containing chemotherapy and have
previously received one or more prior lines of
therapy.1
PADCEV, in combination with pembrolizumab, is indicated for the
treatment of adult patients with locally advanced or metastatic
urothelial cancer (mUC) who are not eligible for
cisplatin-containing chemotherapy.1
This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in the confirmatory trials.
Important Safety Information
Warnings and Precautions
Skin reactions Severe cutaneous adverse reactions,
including fatal cases of SJS or TEN occurred in patients treated
with PADCEV. SJS and TEN occurred predominantly during the first
cycle of treatment but may occur later. Skin reactions occurred in
56% (all grades) of the 753 patients treated with PADCEV as a
single agent in clinical trials. Twenty-four percent (24%) of
patients had maculo-papular rash and 33% had pruritus. Grade 3-4
skin reactions occurred in 12% of patients, including
maculo-papular rash, erythematous rash, rash or drug eruption,
symmetrical drug-related intertriginous and flexural exanthema
(SDRIFE), bullous dermatitis, exfoliative dermatitis, and
palmar-plantar erythrodysesthesia. The median time to onset of
severe skin reactions was 0.7 months (range: 0.1 to 6 months).
Among patients experiencing a skin reaction leading to dose
interruption who then restarted PADCEV (n=59), 24% of patients
restarting at the same dose and 16% of patients restarting at a
reduced dose experienced recurrent severe skin reactions. Skin
reactions led to discontinuation of PADCEV in 2.6% of patients.
When PADCEV was given in combination with pembrolizumab, the
incidence of skin reactions, including severe events, occurred at a
higher rate. Skin reactions occurred in 72% (all grades) of the 121
patients treated with PADCEV in combination with pembrolizumab in
clinical trials. The majority of the skin reactions that occurred
with combination therapy included maculo-papular rash, macular rash
and papular rash. Grade 3-4 skin reactions occurred in 20% of
patients (Grade 3: 19%, Grade 4: 0.8%), including maculo-papular
rash, bullous dermatitis, dermatitis, exfoliative dermatitis,
pemphigoid, rash, erythematous rash, macular rash, and papular
rash. A fatal reaction of bullous dermatitis occurred in one
patient (0.8%). The median time to onset of severe skin reactions
was 2.6 months (range: 0.3 to 16 months). Skin reactions led to
discontinuation of PADCEV in 6% of patients. Monitor patients
closely throughout treatment for skin reactions. Consider topical
corticosteroids and antihistamines, as clinically indicated. For
persistent or recurrent Grade 2 skin reactions, consider
withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for
specialized care for suspected SJS, TEN or for Grade 3 skin
reactions. Permanently discontinue PADCEV in patients with
confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin
reactions.
Hyperglycemia and diabetic ketoacidosis
(DKA). Hyperglycemia and diabetic ketoacidosis (DKA), including
fatal events, occurred in patients with and without pre-existing
diabetes mellitus, treated with PADCEV. Patients with baseline
hemoglobin A1C ≥8% were excluded from clinical trials. In clinical
trials of PADCEV as a single agent, 14% of the 753 patients treated
with PADCEV developed hyperglycemia; 7% of patients developed Grade
3-4 hyperglycemia. Fatal events of hyperglycemia and diabetic
ketoacidosis occurred in one patient each (0.1%). The incidence of
Grade 3-4 hyperglycemia increased consistently in patients with
higher body mass index and in patients with higher baseline A1C.
Five percent (5%) of patients required initiation of insulin
therapy for treatment of hyperglycemia. The median time to onset of
hyperglycemia was 0.6 months (range: 0.1 to 20 months).
Hyperglycemia led to discontinuation of PADCEV in 0.4% of patients.
Closely monitor blood glucose levels in patients with, or at risk
for, diabetes mellitus or hyperglycemia. If blood glucose is
elevated (>250 mg/dL), withhold PADCEV.
Pneumonitis/Interstitial Lung Disease (ILD) Severe,
life-threatening or fatal pneumonitis/ILD occurred in patients
treated with PADCEV. In clinical trials of PADCEV as a single
agent, 2.9% of the 753 patients treated with PADCEV had
pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median
time to onset of pneumonitis/ILD was 2.7 months (range: 0.6 to 6
months). The incidence of pneumonitis/ILD, including severe events
occurred at a higher rate when PADCEV was given in combination with
pembrolizumab. When PADCEV was given in combination with
pembrolizumab, 9% of the 121 patients treated with combination
therapy had pneumonitis/ILD of any grade and 3.3% had Grade 3. A
fatal event of pneumonitis occurred in one patient (0.8%). The
median time to onset of pneumonitis/ILD was 6 months (range: 0.6 to
26 months). Monitor patients for signs and symptoms indicative of
pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial
infiltrates on radiologic exams. Evaluate and exclude infectious,
neoplastic and other causes for such signs and symptoms through
appropriate investigations. Withhold PADCEV for patients who
develop Grade 2 pneumonitis/ILD and consider dose reduction.
Permanently discontinue PADCEV in all patients with Grade 3 or 4
pneumonitis/ILD.
Peripheral neuropathy (PN) Peripheral neuropathy occurred
in 53% of the 753 patients treated with PADCEV as a single agent in
clinical trials including 40% with sensory neuropathy, 7% with
muscular weakness and 7% with motor neuropathy. Thirty percent of
patients experienced Grade 2 reactions and 5% experienced Grade 3-4
reactions. Peripheral neuropathy occurred in patients treated with
PADCEV with or without preexisting peripheral neuropathy. The
median time to onset of Grade ≥2 peripheral neuropathy was 4.9
months (range: 0.1 to 20 months). Neuropathy led to treatment
discontinuation in 7% of patients. Of the patients who experienced
neuropathy who had data regarding resolution (N = 319), 14% had
complete resolution, 46% had partial improvement, and 40% had no
improvement at the time of their last evaluation. Of the 86% of
patients with residual neuropathy at last evaluation, 51% had Grade
2 or greater neuropathy at the time of their last evaluation. The
incidence of peripheral neuropathy occurred at a higher rate when
PADCEV was given in combination with pembrolizumab. When PADCEV was
given in combination with pembrolizumab, 65% of the 121 patients
treated with combination therapy had peripheral neuropathy of any
grade, 45% had Grade 2 neuropathy, and 3.3% had Grade 3 neuropathy.
The median time to onset of Grade ≥2 peripheral neuropathy was 6
months (range: 0.3 to 25 months). Monitor patients for symptoms of
new or worsening peripheral neuropathy and consider dose
interruption or dose reduction of PADCEV when peripheral neuropathy
occurs. Permanently discontinue PADCEV in patients who develop
Grade ≥3 peripheral neuropathy.
Ocular disorders were reported in 40% of the 384
patients treated with PADCEV as a single agent in clinical trials
in which ophthalmologic exams were scheduled. The majority of these
events involved the cornea and included events associated with dry
eye such as keratitis, blurred vision, increased lacrimation,
conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry
eye symptoms occurred in 34% of patients, and blurred vision
occurred in 13% of patients, during treatment with PADCEV. The
median time to onset to symptomatic ocular disorder was 1.6 months
(range: 0 to 19 months). Monitor patients for ocular disorders.
Consider artificial tears for prophylaxis of dry eyes and
ophthalmologic evaluation if ocular symptoms occur or do not
resolve. Consider treatment with ophthalmic topical steroids, if
indicated after an ophthalmic exam. Consider dose interruption or
dose reduction of PADCEV for symptomatic ocular disorders.
Infusion site extravasation Skin and soft tissue
reactions secondary to extravasation have been observed after
administration of PADCEV. Of the 753 patients treated with PADCEV
as a single agent in clinical trials, 1.5% of patients experienced
skin and soft tissue reactions, including 0.3% who experienced
Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling,
increased temperature, and pain worsened until 2-7 days after
extravasation and resolved within 1-4 weeks of peak. Two patients
(0.3%) developed extravasation reactions with secondary cellulitis,
bullae, or exfoliation. Ensure adequate venous access prior to
starting PADCEV and monitor for possible extravasation during
administration. If extravasation occurs, stop the infusion and
monitor for adverse reactions.
Embryo-fetal toxicity PADCEV can cause fetal harm
when administered to a pregnant woman. Advise patients of the
potential risk to the fetus. Advise female patients of reproductive
potential to use effective contraception during PADCEV treatment
and for 2 months after the last dose. Advise male patients with
female partners of reproductive potential to use effective
contraception during treatment with PADCEV and for 4 months after
the last dose.
Adverse Reactions
Most common adverse reactions, including laboratory
abnormalities (≥20%) (PADCEV monotherapy)
Rash, aspartate aminotransferase increased, glucose increased,
creatinine increased, fatigue, peripheral neuropathy, lymphocytes
decreased, alopecia, decreased appetite, hemoglobin decreased,
diarrhea, sodium decreased, nausea, pruritus, phosphate decreased,
dysgeusia, alanine aminotransferase increased, anemia, albumin
decreased, neutrophils decreased, urate increased, lipase
increased, platelets decreased, weight decreased and dry skin.
EV-301 Study: 296 patients previously treated with a PD-1/L1
inhibitor and platinum-based chemotherapy.
Serious adverse reactions occurred in 47% of patients treated
with PADCEV; the most common (≥2%) were urinary tract infection,
acute kidney injury (7% each) and pneumonia (5%). Fatal adverse
reactions occurred in 3% of patients, including multiorgan
dysfunction (1.0%), hepatic dysfunction, septic shock,
hyperglycemia, pneumonitis and pelvic abscess (0.3% each). Adverse
reactions leading to discontinuation occurred in 17% of patients;
the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions
leading to dose interruption occurred in 61% of patients; the most
common (≥4%) were PN (23%), rash (11%) and fatigue (9%). Adverse
reactions leading to dose reduction occurred in 34% of patients;
the most common (≥2%) were PN (10%), rash (8%), decreased appetite
and fatigue (3% each). Clinically relevant adverse reactions
(<15%) include vomiting (14%), AST increased (12%),
hyperglycemia (10%), ALT increased (9%), pneumonitis (3%) and
infusion site extravasation (0.7%).
EV-201, Cohort 2 Study: 89 patients previously treated with a
PD-1/L1 inhibitor and not eligible for cisplatin-based
chemotherapy.
Serious adverse reactions occurred in 39% of patients treated
with PADCEV; the most common (≥3%) were pneumonia, sepsis and
diarrhea (5% each). Fatal adverse reactions occurred in 8% of
patients, including acute kidney injury (2.2%), metabolic acidosis,
sepsis, multiorgan dysfunction, pneumonia and pneumonitis (1.1%
each). Adverse reactions leading to discontinuation occurred in 20%
of patients; the most common (≥2%) was PN (7%). Adverse reactions
leading to dose interruption occurred in 60% of patients; the most
common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%),
AST increased and hyperglycemia (3% each). Adverse reactions
leading to dose reduction occurred in 49% of patients; the most
common (≥3%) were PN (19%), rash (11%) and fatigue
(7%). Clinically relevant adverse reactions (<15%) include
vomiting (13%), AST increased (12%), lipase increased (11%), ALT
increased (10%), pneumonitis (4%) and infusion site extravasation
(1%).
EV-103 Study: 121 patients with previously untreated locally
advanced or metastatic urothelial cancer who were not eligible for
cisplatin-containing chemotherapy (PADCEV in combination with
pembrolizumab)
The most common adverse reactions, including laboratory
abnormalities (≥20%), of PADCEV in combination with pembrolizumab
were glucose increased, aspartate aminotransferase increased, rash,
hemoglobin decreased, creatinine increased, peripheral neuropathy,
lymphocytes decreased, fatigue, alanine aminotransferase increased,
sodium decreased, lipase increased, albumin decreased, alopecia,
phosphate decreased, decreased weight, diarrhea, pruritus,
decreased appetite, nausea, dysgeusia, potassium decreased,
neutrophils decreased, urinary tract infection, constipation,
potassium increased, calcium increased, peripheral edema, dry eye,
dizziness, arthralgia, and dry skin.
Serious adverse reactions occurred in 50% of patients treated
with PADCEV in combination with pembrolizumab. The most common
serious adverse reactions (≥2%) were acute kidney injury (7%),
urinary tract infection (7%), urosepsis (5%), sepsis (3.3%),
pneumonia (3.3%), hematuria (3.3%), pneumonitis (3.3%), urinary
retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%),
myositis (2.5%), anemia (2.5%), and hypotension (2.5%). Fatal
adverse reactions occurred in 5% of patients treated with
PADCEV in combination with pembrolizumab including sepsis (1.6%),
bullous dermatitis (0.8%), myasthenia gravis (0.8%), and
pneumonitis/ILD (0.8%). Adverse reactions leading to
discontinuation of PADCEV occurred in 36% of patients. The most
common adverse reactions (≥2%) leading to discontinuation of
PADCEV were peripheral neuropathy (20%) and rash (6%). Adverse
reactions leading to dose interruption of PADCEV occurred in 69% of
patients. The most common adverse reactions (≥2%) leading to
dose interruption of PADCEV were peripheral neuropathy (18%),
rash (12%), lipase increased (6%), pneumonitis (6%), diarrhea
(4.1%), acute kidney injury (3.3%), alanine aminotransferase
increased (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract
infection (3.3%), amylase increased (2.5%), anemia (2.5%), COVID-19
(2.5%), hyperglycemia (2.5%), and hypotension (2.5%). Adverse
reactions leading to dose reduction of PADCEV occurred in 45% of
patients. The most common adverse reactions (≥2%) leading to
dose reduction of PADCEV were peripheral neuropathy (17%), rash
(12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%).
Drug Interactions
Effects of other drugs on PADCEV (Dual P-gp and
Strong CYP3A4 Inhibitors)
Concomitant use with dual P-gp and strong CYP3A4 inhibitors may
increase unconjugated monomethyl auristatin E exposure, which may
increase the incidence or severity of PADCEV toxicities. Closely
monitor patients for signs of toxicity when PADCEV is given
concomitantly with dual P-gp and strong CYP3A4 inhibitors.
Specific Populations
Lactation Advise lactating women not to breastfeed during
treatment with PADCEV and for at least 3 weeks after the last
dose.
Hepatic impairment Avoid the use of PADCEV in
patients with moderate or severe hepatic impairment.
For more information, please see the full Prescribing
Information including BOXED WARNING for
PADCEV here.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting
business in more than 70 countries around the world. We are
promoting the Focus Area Approach that is designed to identify
opportunities for the continuous creation of new drugs to address
diseases with high unmet medical needs by focusing on Biology and
Modality. Furthermore, we are also looking beyond our foundational
Rx focus to create Rx+® healthcare solutions that
combine our expertise and knowledge with cutting-edge technology in
different fields of external partners. Through these efforts,
Astellas stands on the forefront of healthcare change to turn
innovative science into VALUE for patients. For more information,
please visit our website
at https://www.astellas.com/en.
About Seagen
Founded 25 years ago, Seagen Inc. is a global biotechnology
company that discovers, develops, manufactures and commercializes
targeted cancer therapeutics, with antibody-drug conjugates (ADCs)
at our core. Our colleagues work together with urgency to improve
and extend the lives of people living with cancer. An ADC
technology trailblazer, approximately one-third of FDA-approved and
marketed ADCs use Seagen technology. Seagen is headquartered in
Bothell, Washington and has
locations in California,
Canada, Switzerland and across Europe. For additional information,
visit seagen.com and follow us
on Twitter and LinkedIn.
About the Astellas, Seagen and Merck Collaboration
Astellas and Seagen entered a clinical collaboration agreement
with Merck to evaluate the combination of Astellas' and Seagen's
PADCEV® (enfortumab vedotin-ejfv) and Merck's
KEYTRUDA® (pembrolizumab) in patients with previously
untreated metastatic urothelial cancer. KEYTRUDA is a registered
trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck
& Co., Inc., Rahway, NJ,
USA.
Astellas Cautionary Notes
In this press release, statements made with respect to current
plans, estimates, strategies and beliefs and other statements that
are not historical facts are forward-looking statements about the
future performance of Astellas. These statements are based on
management's current assumptions and beliefs in light of the
information currently available to it and involve known and unknown
risks and uncertainties. A number of factors could cause actual
results to differ materially from those discussed in the
forward-looking statements. Such factors include, but are not
limited to: (i) changes in general economic conditions and in laws
and regulations, relating to pharmaceutical markets, (ii) currency
exchange rate fluctuations, (iii) delays in new product launches,
(iv) the inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas'
intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development), which is included in this press release,
is not intended to constitute an advertisement or medical
advice.
Seagen Forward-Looking Statements
Certain statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic potential of enfortumab vedotin, alone or in
combination, and its possible efficacy, safety and therapeutic
uses; the potential for results from the EV-302 trial to change
practice, offer a new standard of care, or serve as the basis for
global submissions and as the confirmatory trial for the U.S.
accelerated approval of the combination of enfortumab vedotin and
pembrolizumab; plans to present results at an upcoming medical
conference, discuss the results with regulators and deliver
medicine to patients; planned and ongoing clinical trials; and the
development program for enfortumab 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, without limitation, the possibility that data
from the EV-302 trial may not be sufficient to support any
regulatory approvals or to convert accelerated approval in the U.S.
to regular approval; adverse events and newly-emerging safety
signals; adverse regulatory actions; delays, setbacks or failures
in product development activities, the submission of regulatory
applications and the regulatory review process for a variety of
reasons, including, without limitation, the inherent difficulty and
uncertainty of pharmaceutical product development; possible
required modifications to clinical trials; failure to properly
conduct or manage clinical trials; and failure of clinical results
to support continued development or regulatory approvals. 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, 2023 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.
____________________
|
1 National
Cancer Institute. What is bladder cancer?
https://www.cancer.gov/types/bladder#:~:text=Types%20of%20bladder%20cancer,bladder%20cancers%20are%20urothelial%20carcinomas.
Accessed 08-10-2023.
|
2 American
Society of Clinical Oncology. Bladder cancer: introduction
(12-2021).
https://www.cancer.net/cancer-types/bladder-cancer/introduction.
Accessed 08-10-2023.
|
3
International Agency for Research on Cancer. Cancer Today:
bladder globocan 2020 fact sheet (12-2020).
https://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf.
Accessed 08-10-2023.
|
4 Siegel RL,
Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J
Clin 2023;73(1):17-48.
|
5 Cancer
Information Service, Cancer Statistics in Japan. Published
2022. https://ganjoho.jp/public/qa_links/report/statistics/pdf/cancer_statistics_2023_data_E.pdf.
Accessed September 15, 2023.
|
6 Bladder
cancer: The forgotten cancer. Uroweb. (n.d.).
https://uroweb.org/news/bladder-cancer-the-forgotten-cancer.
Accessed September 15, 2023.
|
7National
Cancer Institute. Cancer stat facts: bladder cancer.
https://seer.cancer.gov/statfacts/html/urinb.html. Accessed
08-10-2023.
|
8
Challita-Eid PM, Satpayev D, Yang P, et al. Enfortumab vedotin
antibody-drug conjugate targeting nectin-4 is a highly potent
therapeutic agent in multiple preclinical cancer models. Cancer Res
2016;76(10):3003-13.
|
9 PADCEV [package insert].
Northbrook, IL: Astellas Pharma US, Inc.
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/padcev-enfortumab-vedotin-ejfv-and-keytruda-pembrolizumab-significantly-improve-overall-survival-and-progression-free-survival-in-patients-with-previously-untreated-advanced-bladder-cancer-in-pivotal-phase-3-ev-302-trial-301935662.html
SOURCE Astellas Pharma Inc.