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Astellas Highlights Continued Delivery of Strong Cancer Portfolio and Pipeline at 2023 ASCO Annual Meeting

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PR Newswire

TOKYO, May 25, 2023

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

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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

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