Abstracts represent exciting research progress
across four cancers where patients have limited treatment
options
TOKYO, May 12, 2022
/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D., "Astellas")
will share new research during the 2022 American Society of
Clinical Oncology (ASCO) Annual Meeting from June 3-7 and the European Hematology Association
(EHA) 2022 Hybrid Congress from June
9-12. A total of 13 abstracts from the company's expanding
portfolio of approved and investigational therapies will be
presented across both meetings, underscoring the company's
commitment to advancing treatment options for advanced and rare
cancers, including prostate, pancreatic and urothelial cancer, as
well as acute myeloid leukemia (AML).
"While a robust Phase 3 clinical trial program in
gastric/gastroesophageal junction cancer for our investigational
therapy zolbetuximab is well underway, the ASCO Annual Meeting will
include the first trial-in-progress presentation from our expanded
Phase 2 clinical trial in Claudin 18.2-positive pancreatic cancer,"
said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head
of Development Therapeutic Areas, Astellas. "The progress of these
clinical studies reflects our enthusiasm to continue investigating
the potential to benefit patients by targeting the emerging Claudin
18.2 biomarker."
"At Astellas, our mission is to not only advance innovative
science, but to create value for patients and the oncology
community," said Erhan Berrak, M.D.,
Vice President of Global Medical Affairs, Oncology, Astellas. "Our
advanced prostate cancer data at ASCO, which range from new
analyses of our ARCHES pivotal trial in metastatic
hormone-sensitive prostate cancer to data on patient preferences
and prescriber treatment decisions, will help inform discussions
between patients and providers about novel hormone
therapies."
Highlights at the 2022 ASCO Annual Meeting include:
- An overview of the expanded Phase 2 open-label, randomized
study of zolbetuximab in combination with nab-paclitaxel and
gemcitabine as an investigational first-line treatment for patients
with Claudin 18.2-positive metastatic pancreatic cancer
- Long-term (24-month) data from the Phase 3 EV-301 trial, which
evaluated enfortumab vedotin versus chemotherapy in adult patients
with locally advanced or metastatic urothelial cancer who were
previously treated with platinum-based chemotherapy and a PD-1/L1
inhibitor
- Four post-hoc analyses from the Phase 3 ARCHES study, which
compared enzalutamide plus androgen deprivation therapy (ADT)
versus placebo plus ADT in men with metastatic hormone-sensitive
prostate cancer (mHSPC)
Highlights at the EHA 2022 Hybrid Congress include:
- Encore data from the COMMODORE Phase 3 confirmatory study of
gilteritinib versus salvage chemotherapy in FLT3 mutation-positive
relapsed or refractory AML in China and other countries
- An overview of the CLEVO non-interventional investigational
study of FLT3 mutation frequency in patients with AML in
Europe and the U.S.
Astellas Presentations at 2022 ASCO Annual Meeting
Enfortumab Vedotin
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Long-term outcomes in
EV-301: 24-month findings from the Phase 3 trial of enfortumab
vedotin versus chemotherapy in patients with previously treated
advanced urothelial carcinoma
|
J. Rosenberg
|
Type: Poster
Discussion
Abstract Number:
4516
Date: Saturday, June 4,
2022
Poster Session:
Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 –
4:15 p.m. CDT
Poster Discussion
Session: Genitourinary Cancer – Kidney and Bladder
Presentation: 4:30 – 6
p.m. CDT
|
Benchmarking
maintenance therapy survival in first-line advanced urothelial
carcinoma using disease modeling
|
M. Galsky
|
Type: Poster
Presentation
Abstract Number:
4575
Date: Saturday, June 4,
2022
Poster Session:
Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 –
4:15 p.m. CDT
|
Real-world treatment
patterns and clinical outcomes with first-line therapy in
cisplatin-eligible and ineligible patients with advanced urothelial
carcinoma
|
G. Sonpavde
|
Type: Poster
Presentation
Abstract Number:
4565
Date: Saturday, June 4,
2022
Poster Session:
Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 –
4:15 p.m. CDT
|
Study EV-103 Cohort H:
Antitumor activity of neoadjuvant treatment with enfortumab vedotin
monotherapy in patients with muscle-invasive bladder cancer who are
cisplatin-ineligible
|
D. Petrylak
|
Type: Poster
Presentation
Abstract Number:
4582
Date: Saturday, June 4,
2022
Poster Session:
Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 –
4:15 p.m. CDT
|
Enzalutamide
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Radiographic
progression in the absence of prostate-specific antigen (PSA)
progression in patients with metastatic hormone-sensitive prostate
cancer (mHSPC): Post hoc analysis of ARCHES
|
A. Armstrong
|
Type: Poster
Presentation
Abstract Number:
5072
Date: Monday, June 6,
2022
Poster Session:
Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 –
4:15 p.m. CDT
|
Prevalence of DNA
damage repair (DDR) alterations in patients with metastatic
hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide
(ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT):
ARCHES post hoc analysis
|
A. Azad
|
Type: Poster
Presentation
Abstract Number:
5074
Date: Monday, June 6,
2022
Poster Session:
Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 –
4:15 p.m. CDT
|
The association of
germline HSD3B1 genotype with outcomes in metastatic
hormone-sensitive prostate cancer (mHSPC) treated with androgen
deprivation therapy (ADT) with or without enzalutamide (ENZA)
[ARCHES]
|
N. Sharifi
|
Type: Poster
Presentation
Abstract Number:
5022
Date: Monday, June 6,
2022
Poster Session:
Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 –
4:15 p.m. CDT
|
Clinical outcomes and
safety of enzalutamide (ENZA) plus androgen-deprivation therapy
(ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) in
patients aged <75 and ≥75 years: ARCHES post hoc
analysis
|
R.
Szmulewitz
|
Type: Poster
Presentation
Abstract Number:
5069
Date: Monday, June 6,
2022
Poster Session:
Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 –
4:15 p.m. CDT
|
Reasons for oncologist
and urologist treatment choice in metastatic castration-sensitive
prostate cancer (mCSPC): A physician survey linked to patient chart
reviews in the United States
|
S. Freedland
|
Type: Poster
presentation
Abstract Number:
5065
Date: Monday, June 6,
2022
Poster Session:
Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 –
4:15 p.m. CDT
|
Patient preferences for
treatment and outcomes in hormone-sensitive prostate cancer
(HSPC)
|
D. George
|
Type: Abstract
publication
Abstract Number:
e18757
|
Zolbetuximab
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Zolbetuximab plus
gemcitabine and nab-paclitaxel (GN) in first-line treatment of
Claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2,
open-label, randomized study
|
W. Park
|
Type: Poster
Presentation
Abstract Number:
TPS4186
Date: Saturday, June 4,
2022
Poster Session:
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and
Hepatobiliary
Presentation: 8 – 11
a.m. CDT
|
Astellas Presentations at EHA 2022 Hybrid Congress
Gilteritinib
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
CLEVO: a
non-interventional study to investigate clonal evolution of
FMS-like tyrosine kinase 3 (FLT3) gene mutations during disease
progression in patients with acute myeloid leukemia
|
P. Vyas
|
Type: Abstract
publication
Abstract Number:
PB1834
|
Gilteritinib versus
salvage chemotherapy for relapsed/refractory FLT3-mutated acute
myeloid leukemia: a Phase 3, randomized, multicenter, open-label
trial in Asia
|
J. Wang
|
Type: Poster
session
Abstract Number:
P554
|
Enfortumab Vedotin and the Astellas and Seagen
Collaboration
Astellas and Seagen are co-developing
enfortumab vedotin under a 50:50 worldwide development and
commercialization collaboration. In the
United States, Astellas and Seagen co-promote enfortumab
vedotin. In the Americas outside the US, Seagen holds
responsibility for commercialization activities and regulatory
filings. Outside of the Americas, Astellas holds responsibility for
commercialization activities and regulatory filings.
Enzalutamide and the Pfizer/Astellas Collaboration
In
October 2009, Medivation, Inc., which
is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered
into a global agreement to jointly develop and commercialize
enzalutamide. The companies jointly commercialize enzalutamide in
the United States and Astellas has
responsibility for manufacturing and all additional regulatory
filings globally, as well as commercializing enzalutamide outside
the United States.
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.
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.
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