On October 15, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will share new research results during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20-24, showcasing the company’s focus on making a meaningful difference for people living with hard-to-treat cancers (Press release, Astellas, OCT 15, 2023, View Source [SID1234635967]). 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.
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"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 (Free ESMO Whitepaper), 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 (Free ESMO Whitepaper), 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 (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) Congress 2023
Enfortumab Vedotin
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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