16 abstracts feature new data and post-hoc
analyses of pivotal trials across several types of hard-to-treat
cancers
TOKYO, May 13, 2024
/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and
CEO: Naoki Okamura, "Astellas") will
share new research from across its innovative portfolio of approved
and investigational cancer therapies during the 2024 American
Society of Clinical Oncology (ASCO) Annual Meeting from
May 31 - June 4. A total of 16
abstracts will be presented, including new data from pivotal trials
supporting ongoing regulatory reviews. The volume of data being
presented by Astellas reinforces its commitment to changing the
course of cancer treatment through targeted therapies for
hard-to-treat cancers like prostate, urothelial, and
gastric/gastroesophageal junction (GEJ) cancers.
Tadaaki Taniguchi, MD, PhD,
Chief Medical Officer, Astellas
"The data at ASCO
demonstrate the strength and breadth of our growing oncology
portfolio and provide new insights into our transformative
therapies for patients living with some of the most devastating
cancers. Recent regulatory achievements mean our oncology medicines
are reaching more patients than ever worldwide, and we are
continuing to pursue novel targets and invest in research to
improve overall survival and raise quality of life."
Highlights at the 2024 ASCO Annual Meeting include:
- Further data from the Phase 3 EV-302 trial
evaluating enfortumab vedotin in combination with
pembrolizumab versus chemotherapy in previously untreated locally
advanced or metastatic urothelial carcinoma (la/mUC), including
data in cisplatin-eligible and cisplatin-ineligible populations.
These results support the combination as a landmark advancement in
the care of patients with la/mUC, regardless of cisplatin
eligibility, and serve as the basis of ongoing regulatory reviews
by the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP), Japan's Ministry of Health, Labour and Welfare
(MHLW), and the China National Medical Products Administration
(NMPA).
- Final overall survival (OS) results from the Phase 3 SPOTLIGHT
study, evaluating the efficacy and safety of zolbetuximab – a
first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody
approved by Japan's MLHW and
currently in review by multiple regulatory authorities for approval
worldwide. In this abstract, zolbetuximab is evaluated in
combination with mFOLFOX6 (a combination chemotherapy regimen that
includes oxaliplatin, leucovorin, and fluorouracil) for the
first-line treatment of patients with CLDN18.2 positive, human
epidermal growth factor receptor 2 (HER2)-negative, locally
advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
These results underpin the strength of the zolbetuximab clinical
data supporting the pursuit of regulatory approvals worldwide.
- Two new post-hoc analyses of the Phase 3 EMBARK trial, which
evaluated enzalutamide plus leuprolide, placebo plus
leuprolide, and enzalutamide (single agent) in patients with
nonmetastatic hormone- (or castration-) sensitive prostate cancer
(nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR),
including an oral presentation on the impact of treatment
suspension on health-related quality of life and a poster
presentation on sexual activity patient-reported
outcomes.
Astellas Presentations at 2024 ASCO Annual Meeting
Enfortumab
Vedotin
|
|
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Impact of exposure on
outcomes with enfortumab vedotin in patients with
locally
advanced or
metastatic urothelial cancer
|
D. Petrylak
|
Type:
Oral
Presentation
Abstract
Number:
4503
Date: June
3, 2024
8:00-11:00
AM
CDT
|
Patient-reported
outcomes (PROs) from a randomized, phase 3 trial of
enfortumab
vedotin plus
pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC)
in
previously untreated
locally advanced or metastatic urothelial cancer
(la/mUC)
|
S. Gupta
|
Type:
Oral
Presentation
Abstract
Number:
4502
Date: June
3, 2024
8:00-11:00
AM
CDT
|
Enfortumab vedotin (EV)
in triple-negative breast cancer (TNBC) and HR+/HER2-
breast cancer (BC)
cohorts of EV-202
|
A. Giordano
|
Type:
Oral
Presentation
Abstract
Number:
1005
Date:
June 1, 2024
3:00-6:00 PM
CDT
|
Enfortumab vedotin (EV)
with pembrolizumab (P) versus chemotherapy (chemo) in
previously
untreated locally advanced or metastatic
urothelial carcinoma (la/mUC): Analysis of
cisplatin
(cis)-eligible population from
EV-302/KEYNOTE-A39
|
J. Bedke
|
Type:
Poster
Presentation
Abstract
Number:
4562
Date: June
2, 2024
9:00 AM-12:00
PM CDT
|
Enfortumab vedotin (EV)
with pembrolizumab (P) versus chemotherapy (chemo) in
previously
untreated locally advanced or metastatic
urothelial carcinoma (la/mUC): Analysis of
the cisplatin (cis)-ineligible
population from EV-302/KEYNOTE-A39
|
M. Van Der
Heijden
|
Type:
Poster
Presentation
Abstract
Number:
4563
Date: June
2, 2024
9:00
AM-12:00
PM CDT
|
Enfortumab vedotin (EV)
in non-squamous and squamous non–small cell lung cancer
(NSCLC) cohorts of
EV-202
|
K. Muro
|
Type:
Poster
Presentation
Abstract
Number:
8585
Date: June
3,2024
1:30-4:30 PM
CDT
|
Enfortumab vedotin (EV)
in previously treated gastric/esophageal cancers cohorts
of
EV-202
|
K. Muro
|
Type:
Poster
Presentation
Abstract
Number:
4046
Date: June
1, 2024
1:30-4:30 PM
CDT
|
Study EV-103:
Neoadjuvant treatment with enfortumab vedotin monotherapy
in
cisplatin-ineligible
patients with muscle invasive bladder cancer (MIBC): 2-year
event-
free survival and
safety data for Cohort H
|
P. O'Donnell
|
Type:
Poster
Presentation
Abstract
Number:
4564
Date: June
2, 2024
9:00
AM-12:00
PM CDT
|
Enfortumab vedotin and
pembrolizumab as first-line treatment in recurrent or
metastatic head and
neck squamous cell carcinoma: a cohort of the EV-202
trial
|
P. Swiecicki
|
Type:
Poster
Presentation
Abstract
Number:
TPS6116
Date: June
2, 2024
9:00
AM-12:00
PM CDT
|
Systematic Literature
Review and Network Meta-Analysis of First-Line Therapies
for
Locally
Advanced/Metastatic Urothelial Carcinoma
|
L. Bloudek
|
Type:
Online
publication
Abstract
Number:
e16547
|
Real-world first-line
treatment patterns and outcomes in patients with locally
advanced
or
metastatic urothelial carcinoma in the United
States
|
R. Chen
|
Type:
Online
Publication
Abstract
Number:
e23287
|
|
Enzalutamide
|
|
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
EMBARK post-hoc
analysis of impact of treatment suspension (TxS) on
health-
related quality of life
(HRQoL)
|
S. Freedland
|
Type: Oral
Presentation
Abstract Number:
5005
Date: June 1,
2024
3:00-6:00PM
CDT
|
EMBARK post hoc
analysis of sexual activity (SA) patient-reported
outcomes
(PROs) in
patients (pts) who were sexually
active or interested in sex at baseline (BL)
|
S. Freedland
|
Type: Poster
Presentation
Abstract Number:
5084
Date: June 2,
2024
9:00 AM-12:00 PM
CDT
|
Physicians use of
first-line treatment intensification in metastatic
castration-
sensitive prostate
cancer (mCSPC): A discrete choice experiment
|
S. Loeb
|
Type: Poster
Presentation
Abstract Number:
5087
Date: June 2,
2024
9:00 AM-12:00 PM
CDT
|
Characteristics and
treatment (Tx) patterns (TxP) of high-risk biochemically
recurrent (HR-BCR)
non-metastatic castration-sensitive prostate cancer in the
real-world by race,
age, and prostate-specific antigen (PSA) doubling time
(PSADT)
|
A. Morgans
|
Type:
Online-Only Abstract
Abstract Number:
e17071
|
|
Zolbetuximab
|
|
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Final overall survival
results from phase 3 SPOTLIGHT study evaluating
zolbetuximab + mFOLFOX6
as first-line (1L) treatment for patients (pts) with
claudin 18 isoform 2
(CLDN18.2)+, HER2−, locally advanced (LA) unresectable
or
metastatic gastric
or gastroesophageal junction (mG/GEJ)
adenocarcinoma
|
K. Shitara
|
Type: Poster
Presentation
Abstract Number:
4036
Date: June 1,
2024
1:30-4:30 PM
CDT
|
About PADCEV and the Astellas, Pfizer and Merck
Collaboration
Astellas and Pfizer have a clinical
collaboration agreement with Merck to evaluate the combination of
Astellas' and Pfizer'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 (known as MSD outside of the United States and Canada).
About XTANDI 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 commercial agreement to jointly develop and commercialize
XTANDI® (enzalutamide) in the
United States, while Astellas has responsibility for
manufacturing and all additional regulatory filings globally, as
well as commercializing the product outside the United States. Pfizer receives alliance
revenues as a share of U.S. profits and receives royalties on sales
outside the U.S.
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. The safety and
efficacy of the agent(s) under investigation have not been
established for the use(s) being considered. There is no guarantee
that the agent(s) will receive regulatory approval and become
commercially available for the use(s) being investigated.
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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