Data at meeting illustrate company's progress
in addressing unmet needs in a broad range of hard-to-treat solid
tumors and hematologic malignancies
TOKYO, May 25, 2023
/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and
CEO: Naoki Okamura, "Astellas") will
share new research from across its expanding portfolio of approved
and investigational cancer therapies during the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting from
June 2-6. A total of 15 abstracts,
covering three approved medicines and one investigational therapy,
will be presented underscoring the company's focus on pursuing
targeted therapies for hard-to-treat cancers where few therapies
exist, including prostate, urothelial, gastric/gastroesophageal
junction (GEJ) and head & neck cancers, as well as acute
myeloid leukemia (AML).
"The research presented at ASCO reflects our intense focus on
how we are continuing to grow the breadth and utility of our
oncology portfolio and pipeline for the oncology community and
patients with cancer, particularly those with advanced disease,"
said Ahsan Arozullah, MD, MPH, Senior Vice President, Head of
Oncology Development, Astellas. "Across our clinical
development programs, these data add to the growing body of
evidence and support our efforts to identify ways we can impact the
course of disease, and redefine what is possible for patients who
need it most."
Highlights at the 2023 ASCO Annual Meeting include:
- A rapid abstract update presentation of investigational data
from the Phase 3 GLOW clinical trial, evaluating the efficacy and
safety of zolbetuximab – an investigational first-in-class
Claudin-18.2 (CLDN18.2) targeted monoclonal antibody – in
combination with CAPOX (a combination chemotherapy regimen that
includes capecitabine and oxaliplatin) for the first-line treatment
of patients with CLDN18.2-positive, HER2-negative, locally advanced
unresectable or metastatic gastric or GEJ adenocarcinoma.
- The first clinical data from the Phase 1 EV-104 study
evaluating intravesical administration of enfortumab vedotin, an
antibody-drug conjugate developed in partnership with Seagen, in
patients with non-muscle invasive bladder cancer.
- The first clinical data from the Phase 2 EV-202 study
evaluating enfortumab vedotin monotherapy in previously treated
advanced head & neck cancers.
"For the first time, we will present clinical data at ASCO
investigating the potential of enfortumab vedotin as monotherapy in
patients with previously treated advanced head and neck cancers,
who have ongoing and unmet therapeutic needs," said Erhan Berrak, MD, Vice President, Medical
Affairs, Oncology Therapeutic Area Head, Astellas. "Additionally,
Astellas is pleased to share investigational data at ASCO that
demonstrate continued progress for our zolbetuximab clinical
development program in locally advanced or metastatic gastric and
GEJ cancers, which have limited effective treatment options."
Astellas Presentations at 2023 ASCO Annual Meeting
Enfortumab Vedotin
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
A first-in-human trial
of intravesical enfortumab vedotin (EV), an antibody-drug conjugate
(ADC), in patients with non-muscle invasive bladder cancer (NMIBC):
Interim results of a phase 1 study (EV-104)
|
A. Kamat
|
Type: Poster
Presentation
Abstract Number:
4596
Date: Sat. June
3, 8:00-11:00 am CDT
Poster Session:
Genitourinary Cancer – Kidney and Bladder
|
Study EV-103 dose
escalation/cohort A: Long-term outcome of enfortumab vedotin +
pembrolizumab in first-line (1L) cisplatin-ineligible locally
advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4
years of follow-up
|
S. Gupta
|
Type: Oral
Presentation
Abstract Number:
4505
Date: Mon. June
5, 12:54 pm CDT
Oral Abstract
Session: Genitourinary Cancer – Kidney and Bladder
|
Enfortumab vedotin in
the previously treated advanced head and neck cancer (HNC) cohort
of EV-202
|
P. Swiecicki
|
Type: Poster
Presentation
Abstract Number:
6017
Date: Mon. June
5, 5:04 pm CDT
Poster Session:
Head and Neck Cancer
|
EV-203: Phase 2 trial
of enfortumab vedotin in patients with previously treated advanced
urothelial carcinoma in China
|
S. Li
|
Type:
Online-Only Abstract
Abstract Number:
e16574
|
Study EV-103:
Neoadjuvant treatment with enfortumab vedotin monotherapy in
cisplatin-ineligible patients (pts) with muscle invasive bladder
cancer (MIBC): Updated results for Cohort H
|
T. Flaig
|
Type: Poster
Presentation
Abstract Number:
4595
Date: Sat. June
3, 8:00-11:00 am CDT
Poster Session:
Genitourinary Cancer – Kidney and Bladder
|
Enfortumab vedotin (EV)
with or without pembrolizumab (P) in patients (pts) who are
cisplatin-ineligible with previously untreated locally advanced or
metastatic urothelial cancer (la/mUC): Additional 3-month follow-up
on cohort K data
|
T. Friedlander
|
Type: Poster
Presentation
Abstract Number:
4568
Date: Sat. June
3, 8:00-11:00 am CDT
Poster Session:
Genitourinary Cancer – Kidney and Bladder
|
Real-world use, dose
intensity, and adherence to an antibody-drug conjugate (ADC) in
metastatic urothelial cancer (mUC)
|
K. Tsingas
|
Type:
Online-Only Abstract
Abstract Number:
e16567
|
KEYNOTE-905/EV-303: A
phase 3 study to evaluate the efficacy and safety of perioperative
pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for
muscle-invasive bladder cancer (MIBC)
|
A. Necchi
|
Type: Poster
Presentation
Abstract Number:
TPS4601
Date: Sat. June
3, 8:00-11:00 am CDT
Poster Session:
Genitourinary Cancer – Kidney and Bladder
|
Enzalutamide
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Longitudinal
transcriptome profiling of localized hormone-sensitive tumors in
treatment-naïve ENACT patients with prostate cancer with and
without enzalutamide (ENZA)
|
A. Ross
|
Type: Poster
Presentation
Abstract Number:
5026
Date: Sat. June
3, 8:00-11:00 am CDT
Poster Session:
Genitourinary Cancer –Prostate, Testicular, and Penile
|
Outcomes of patients
(pts) with de novo metastatic hormone-sensitive prostate cancer
(mHSPC) who progressed to metastatic castration-resistant prostate
cancer (mCRPC): a post-hoc analysis of the TRUMPET
registry
|
D. Shevrin
|
Type:
Online-Only Abstract
Abstract Number:
e17085
|
Real-world baseline
characteristics and first-line (1L) treatment (Tx) in patients
(pts) with de novo metastatic castration-sensitive prostate cancer
(mCSPC) by disease volume
|
S. Freedland
|
Type:
Online-Only Abstract
Abstract Number:
e17081
|
Zolbetuximab
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Zolbetuximab + CAPOX in
1L claudin-18.2+ (CLDN18.2+)/HER2− locally advanced (LA)
unresectable or metastatic gastric or gastroesophageal junction
(mG/GEJ) adenocarcinoma: Primary phase 3 results from GLOW (Rapid
abstract update presentation following March 22 Plenary Series
session)
|
R. Xu
|
Type: Rapid
Oral
Abstract Number:
N/A
Date: Sat. June
3, 1:06 pm CDT
Session: ASCO
Plenary Series: Rapid Abstract Updates
|
Phase 2 trial of
zolbetuximab in combination with mFOLFOX6 and nivolumab in patients
with advanced or metastatic claudin 18.2-positive, HER2-negative
gastric or gastroesophageal junction adenocarcinomas
|
K. Shitara
|
Type: Poster
Presentation
Abstract Number:
TPS4173
Date: Mon. June
5, 8:00-11:00 am CDT
Poster Session:
Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and
Hepatobiliary
|
Global prevalence of
CLDN18.2 positivity in tumor samples from patients with locally
advanced unresectable or metastatic gastric or gastroesophageal
junction adenocarcinoma: Biomarker analysis of two zolbetuximab
phase 3 studies (SPOTLIGHT and GLOW)
|
K. Shitara
|
Type: Poster
Presentation
Abstract Number:
4035
Date: Mon. June
5, 8:00-11:00 am CDT
Poster Session:
Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and
Hepatobiliary
|
Gilteritinib
Presentation
Title
|
Lead
Author
|
Presentation
Details
|
Work Absenteeism and
Disability Days after Diagnosis among Patients with AML and
Caregivers
|
T. LeBlanc
|
Type:
Online-Only Abstract
Abstract Number:
e19002
|
About 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 U.S., Seagen holds responsibility for commercialization
activities and regulatory filings. Outside of the Americas,
Astellas holds responsibility for commercialization activities and
regulatory filings.
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.
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 U.S. 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 agents discussed herein are under
investigation and have not been established. There is no guarantee
that the agents will receive regulatory approval and become
commercially available for uses 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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