– Results of pivotal confirmatory trial
found the enfortumab vedotin plus pembrolizumab combination
significantly extended overall survival and progression-free
survival vs standard platinum containing chemotherapy–
– If approved, the combination would be the
first and only antibody-drug conjugate plus PD-1 inhibitor
treatment alternative to chemotherapy in this patient population
–
Seagen Inc. (Nasdaq: SGEN) and Astellas Pharma Inc. (TSE:4503)
today announced that on November 30, 2023 the U.S. Food and Drug
Administration (FDA) accepted for priority review a supplemental
Biologics License Application (sBLA) for PADCEV® (enfortumab
vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination
therapy for the treatment of adult patients with 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.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has
set a target action date of May 9, 2024. The FDA is reviewing the
application under its Real-Time Oncology Review (RTOR) program,
which aims to explore a more efficient review process to ensure
that safe and effective treatments are available to patients as
early as possible. If approved, this combination would be the first
treatment option for cisplatin eligible and ineligible
patients.
In the U.S., it is estimated that 82,290 people will be
diagnosed with bladder cancer in 2023.i Urothelial cancer accounts
for 90% of all bladder cancers and can also be found in the renal
pelvis, ureter and urethra.ii Approximately 12% of cases are
locally advanced or metastatic urothelial cancer at diagnosis.iii
Most la/mUC patients will progress within nine months and long-term
survival rates are poor.iv
Roger Dansey, M.D., President, Research and Development,
Seagen
“Through our clinical development program, data have
consistently shown the impact of combining enfortumab vedotin with
pembrolizumab for advanced bladder cancer. The FDA’s acceptance of
our application is a critical step in our work as we seek to
deliver this combination to more patients who currently have few
treatment options at the advanced stage.”
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of
Oncology Development, Astellas
“We look forward to the FDA’s review of this application, which,
if approved, will convert the accelerated approval of the
combination based on results from the EV-103 study to standard
approval for all first-line locally advanced or metastatic
urothelial cancer patients, expanding the indication to cisplatin
eligible patients. These patients have a critical need for
innovative new therapies, as chemotherapy has been the standard of
care for over 30 years. We are committed to delivering on our goal
of helping patients with advanced urothelial cancer live
longer.”
The sBLA for first-line use of the combination is based on
results from the Phase 3 EV-302 clinical trial (also known as
KEYNOTE-A39). The study found that the combination improved overall
survival (OS) and progression-free survival (PFS) with
statistically significant and clinically meaningful results in
patients with previously untreated la/mUC compared to
platinum-containing chemotherapy. The safety results were
consistent with those previously reported with this combination,
and no new safety issues were identified.
Please see Important Safety Information at the end of this press
release, including BOXED WARNING for PADCEV (enfortumab
vedotin-ejfv).
In February 2020, PADCEV in combination with KEYTRUDA was
granted Breakthrough Therapy designation by the FDA and the EV-103
sBLA received Priority Review designation in December 2022. In
April 2023, the FDA granted accelerated approval to the combination
for the treatment of adult patients with la/mUC who are not
eligible to receive cisplatin-containing chemotherapy based on
tumor response rate and durability of response from the EV-103
trial. The EV-302 trial, which is intended to serve as the
confirmatory trial for the U.S. accelerated approval and as the
basis for global regulatory submissions, is also intended to expand
the indication into the cisplatin-eligible patient population.
About EV-302
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. The study enrolled 886 patients with previously
untreated la/mUC who were eligible for cisplatin- or
carboplatin-containing chemotherapy regardless of PD-L1 status.
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). Select secondary endpoints
include overall response rate (ORR) and duration of response (DOR)
per RECIST v1.1 by BICR, and safety.
The EV-302 trial is part of an extensive program evaluating this
combination in multiple stages of urothelial cancer and other solid
tumors. Findings from EV-302 were presented at the European Society
for Medical Oncology (ESMO) Congress 2023 in October 2023.
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.ii
- 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. v
- Globally, approximately 573,000 new cases of bladder cancer and
212,000 deaths are reported annually.vi
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 MIBC has not been
proven safe or effective.
The EV-202 trial (NCT04225117) is an ongoing, multi-cohort,
open-label, multicenter Phase 2 study investigating enfortumab
vedotin alone in patients with previously treated advanced solid
tumors. This study also has a cohort that is investigating
enfortumab vedotin in combination with pembrolizumab in patients
with previously untreated recurrent/metastatic head and neck
squamous cell carcinoma.
About PADCEV® (enfortumab vedotin-ejfv)
PADCEV (enfortumab vedotin-ejfv) is a first-in-class
antibody-drug conjugate (ADC) that is directed to Nectin-4, a
protein located on the surface of cells and highly expressed in
bladder cancer.vii 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).viii
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 li(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 U.S. full Prescribing
Information including BOXED WARNING for PADCEV
here.
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 X and LinkedIn.
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 the Seagen, Astellas and Merck Collaboration
Seagen and Astellas entered a clinical collaboration agreement
with Merck to evaluate the combination of Seagen’s and Astellas’
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.
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 PADCEV, alone or in combination; its
possible efficacy, safety and therapeutic uses; the potential for
results from the EV-302 trial to serve as the confirmatory trial to
convert the U.S. accelerated approval to standard approval, expand
the indication into the cisplatin-eligible patient population and
serve as the basis for global regulatory submissions; planned and
ongoing clinical trials; and the development program for PADCEV.
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 convert U.S. accelerated approval to standard approval, to
expand the indication into the cisplatin-ineligible population or
to support global regulatory approvals; adverse events and
newly-emerging safety signals; adverse regulatory actions; delays,
setbacks or failures in product development activities 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 September 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.
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.
____________________ i Key statistics for Bladder Cancer.
American Cancer Society. (n.d.).
https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html
ii National Cancer Institute. What is bladder cancer?
https://www.cancer.gov/types/bladder#:~:text=Types%20of%20bladder%20cancer,bladder%20cancers%20are%20urothelial%20carcinomas.
Accessed October 30, 2023. iiiNational Cancer Institute. Cancer
stat facts: bladder cancer.
https://seer.cancer.gov/statfacts/html/urinb.html. Accessed October
30, 2023. iv Galsky MD, Pal SK, Lin SW, Ogale S, et al. (2018).
Real-world effectiveness of chemotherapy in elderly patients with
metastatic bladder cancer in the United States. Bladder Cancer
4(2):227-38. v American Society of Clinical Oncology. Bladder
cancer: introduction (12-2021).
https://www.cancer.net/cancer-types/bladder-cancer/introduction.
Accessed October 30, 2023. vi 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 October 30, 2023. vii 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. viii
PADCEV [package insert]. Northbrook, IL: Astellas Pharma US,
Inc.
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Seagen Contacts: For Media David Caouette Vice President,
Corporate Communications (310) 430-3476 dcaouette@seagen.com
For Investors Douglas Maffei, Ph.D. Vice President, Investor
Relations & ESG (425) 527-4881 dmaffei@seagen.com
Astellas Contacts: For Media Elysia Wood (703) 722-4656
elysia.wood@astellas.com
For Investors Astellas Pharma Inc. Corporate Communications
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Seagen (NASDAQ:SGEN)
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Seagen (NASDAQ:SGEN)
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