Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023

Data include three late-breaking abstracts, underscoring Astellas' efforts to potentially redefine expectations for patients across its oncology portfolio

TOKYO, Oct. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company's focus on making a meaningful difference for people living with hard-to-treat cancers. A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas

"At Astellas, we're working to change the course of cancer care, including through scientific advancements to address pressing unmet needs. We look forward to sharing our latest investigational data at ESMO, including data from the Phase 3 EV-302 study of enfortumab vedotin, which is developed in partnership with Seagen, in combination with Merck's pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer in a late-breaking presentation. We will also present expanded data from a Phase 3 study investigating enzalutamide plus leuprolide in patients with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence."

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas

"Over the last several months, Astellas has demonstrated considerable progress in our efforts to make a purposeful impact in the care of patients with advanced gastric cancer through regulatory submissions for our investigational therapy, zolbetuximab, across the U.S., Asia, and Europe. During ESMO, we will share updated data from two Phase 3 clinical studies, highlighting important clinical data of zolbetuximab in gastric and GEJ cancer patients whose tumors are CLDN18.2-positive."

Other highlights at the ESMO Congress 2023 include:

  • Data from Cohort L of the EV-103 study evaluating enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)
  • Health-related quality of life (HRQoL) data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab as a first-line treatment in patients with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2 (CLDN18.2)-positive
  • HRQoL data in nonmetastatic hormone-sensitive prostate cancer (nmHSPC) patients with high-risk biochemical recurrence (BCR) from the EMBARK study evaluating enzalutamide plus leuprolide, leuprolide plus placebo, and enzalutamide monotherapy

Astellas Presentations at ESMO Congress 2023

Enfortumab Vedotin

Presentation Title

Speaker

Presentation Details

EV-302/KEYNOTE-A39: Open-label, randomized Phase
3 study of enfortumab vedotin in combination with
pembrolizumab (EV+P) vs chemotherapy (chemo) in
previously untreated locally advanced metastatic
urothelial carcinoma (la/mUC)

T. B. Powles

Type: Presidential 2

Abstract Number: LBA6

Date: Sunday, October 22

Study EV-103 Cohort L: Perioperative treatment w/
enfortumab vedotin (EV) monotherapy in cisplatin (cis)-
ineligible patients (pts) w/ muscle invasive bladder
cancer (MIBC)

S. Sridhar

Type: Mini Oral

Abstract Number: 2365MO

Date: Sunday, October 22


Enzalutamide

Presentation Title

Speaker

Presentation Details

Health-related quality of life in nonmetastatic hormone-
sensitive prostate cancer patients with high-risk
biochemical recurrence from the EMBARK study

S. Freedland

Type: Mini Oral

Abstract Number: 1766MO

Date: Sunday, October 22

Treatment of high-risk biochemically recurrent prostate
cancer with enzalutamide in combination with leuprolide
acetate: Secondary endpoints from EMBARK

N. Shore

Type: Poster

Abstract Number: 1778P

Date: Sunday, October 22

Enzalutamide monotherapy for the treatment of prostate
cancer with high-risk biochemical recurrence: EMBARK
secondary endpoints

U. F. De Giorgi

Type: Poster

Abstract Number: 1777P

Date: Sunday, October 22

Real-world overall survival with enzalutamide and
abiraterone acetate in patients with chemotherapy-naïve
metastatic castration-resistant prostate cancer

S. Freedland

Type: Poster

Abstract Number: 1827P

Date: Sunday, October 22

China ARCHES: a multicenter, Phase 3, randomized,
double-blind, placebo-controlled efficacy and safety trial
of enzalutamide + androgen deprivation therapy (ADT)
vs placebo + ADT in Chinese patients with metastatic
hormone-sensitive prostate cancer

G. Zeng

Type: Poster

Abstract Number: 1795P

Date: Sunday, October 22

Blood based biomarkers identify metastatic castration-
resistant prostate cancer with the greatest benefit from
continuing enzalutamide beyond progression in
combination with docetaxel: a pre-specified biomarker
study of the phase 3b PRESIDE trial

M. Ruiz Vico

Type: Poster

Abstract Number: 1836P

Date: Sunday, October 22

Zolbetuximab

Presentation Title

Speaker

Presentation Details

Updated efficacy and safety results from phase 3 GLOW
study evaluating zolbetuximab + CAPOX as first-line (1L)
treatment for patients with claudin-18 isoform 2-positive
(CLDN18.2)+, HER2−, locally advanced (LA)
unresectable or metastatic gastric or gastroesophageal
junction (mG/GEJ) adenocarcinoma

F. Lordick

Type: Mini Oral

Abstract Number: LBA81

Date: Saturday, October 21

Updated efficacy and safety results from phase 3
SPOTLIGHT study evaluating zolbetuximab +
mFOLFOX6 as first-line (1L) treatment for patients with
claudin-18 isoform 2-positive (CLDN18.2+), HER2−,
locally advanced (LA) unresectable or metastatic gastric
or gastroesophageal junction (mG/GEJ) adenocarcinoma

J. A. Ajani

Type: Mini Oral

Abstract Number: LBA82

Date: Saturday, October 21

Health-related quality of life (HRQoL) in patients with
claudin-18 isoform 2-positive (CLDN18.2+) locally
advanced (LA) unresectable or metastatic gastric or
gastroesophageal junction (mG/GEJ) adenocarcinoma:
results from SPOTLIGHT and GLOW

F. Lordick

Type: Poster

Abstract Number: 1530P

Date: Monday, October 23

Effects of antiemetics on zolbetuximab-induced gastric
injury and emesis frequency in ferrets

J. Wang

Type: Poster

Abstract Number: 38P

Date: Sunday, October 22

Real-world practices and physician perspectives on
biomarker testing and treatment patterns in patients with
locally advanced unresectable or metastatic (la/m)
gastric/gastroesophageal junction (G/GEJ)
adenocarcinoma in the US

K. Lewis

Type: Poster

Abstract Number: 160P

Date: Saturday, October 21

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.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-to-share-new-data-across-hard-to-treat-cancers-during-esmo-congress-2023-301956897.html

SOURCE Astellas Pharma Inc.


Company Codes: Tokyo:4503, OTC-PINK:ALPMY, NYSE:PFE, NEO:PFE

Back to news