Astellas to Present Data from Expanding Oncology Portfolio During the 2021 ASCO Annual Meeting

On May 17, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it will share new data across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Astellas, MAY 17, 2021, View Source [SID1234580110]). Covering three approved treatments and one investigational therapy, the 12 Astellas-sponsored abstracts underscore the company’s commitment to advancing treatment options for difficult-to-treat cancers, including bladder, prostate and gastric/gastroesophageal junction (GEJ) cancers, as well as acute myeloid leukemia (AML).

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"While oncology has seen incredible advancements over the last decade, there are still many patients whose disease has few or no effective treatments. Astellas is determined to change that reality," said Andrew Krivoshik, M.D., Ph.D., Astellas Senior Vice President and Oncology Therapeutic Area Head. "Our data suggest that progress is possible, and we are committed to working with physicians, patients and others in the cancer community to change the course of hard-to-treat forms of cancer."

"The latest investigational research supported by Astellas reflects our commitment to understanding unmet needs in cancer care and our mission to turn innovative science into treatments that are truly valued by patients and healthcare professionals," said Erhan Berrak, M.D., Astellas Vice President of Medical Affairs, Oncology. "For example, research to be presented at ASCO (Free ASCO Whitepaper) includes a closer look at real-world treatment patterns in several clinical states of advanced prostate cancer, including the use of advanced treatments across racial groups – a topic closely aligned with the ASCO (Free ASCO Whitepaper) 2021 theme of equity."

Astellas will share data across its portfolio and investigational therapies, with highlights including:

Quality of life results from the Phase 3 EV-301 trial of enfortumab vedotin (EV) and an updated analysis of efficacy and safety data from EV-201 cohort 2 of EV; updated durability and long-term outcomes from the EV-103 clinical trial of EV and pembrolizumab – all in advanced types of urothelial cancer
Research on racial disparities in advanced prostate cancer treatment, as well as real-world treatment patterns for patients with advanced prostate cancer
Follow-up data from the Phase 3 ADMIRAL trial evaluating gilteritinib in patients with relapsed or refractory (resistant to treatment) AML with a FLT3 mutation
Data from the Phase 2 study of zolbetuximab plus mFOLFOX6 in claudin 18.2-positive (CLDN18.2+) locally advanced or metastatic gastric or GEJ adenocarcinoma
Astellas Presentations at ASCO (Free ASCO Whitepaper)21

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Enfortumab vedotin in cisplatin-ineligible
patients with locally advanced or
metastatic urothelial cancer who
received prior PD-1/PD-L1 inhibitors: An
updated analysis of EV-201 Cohort 2

B. McGregor

Type: Poster

Abstract Number: 4524

Study EV-103: Update on durability
results and long-term outcome of
enfortumab vedotin + pembrolizumab in
first line locally advanced or metastatic
urothelial carcinoma (la/mUC)

T. Friedlander

Type: Poster

Abstract Number: 4528

Quality of life, functioning, and
symptoms in patients with previously
treated locally advanced or metastatic
urothelial carcinoma from EV-301: A
randomized phase 3 trial of enfortumab
vedotin vs chemotherapy

R. Mamtani

Type: Poster

Abstract Number: 4539

KEYNOTE-B15/EV-304: Randomized
phase 3 study of perioperative
enfortumab vedotin plus pembrolizumab
versus chemotherapy in cisplatin-
eligible patients with muscle-invasive
bladder cancer (MIBC)

C. Hoimes

Type: Poster

Abstract Number: TPS4587

Opioid use in locally advanced or
metastatic urothelial carcinoma patients
and matched non-cancer controls

S. Grewal

Type: Publication Only

Abstract Number: e16517

Enzalutamide

Presentation Title

Lead Author

Presentation Details

The efficacy of enzalutamide (ENZA)
plus androgen deprivation therapy
(ADT) on bone oligometastatic
hormone-sensitive prostate cancer: A
post hoc analysis of ARCHES

A. Armstrong

Type: Poster

Abstract Number: 5071

Real world first-line (1L) treatment
patterns in patients (pts) with metastatic
castration-sensitive prostate cancer
(mCSPC) in a U.S. health insurance
database

U. Swami

Type: Poster

Abstract Number: 5072

Real-world utilization of advanced
therapies and racial disparity among
patients with metastatic castration-
sensitive prostate cancer (mCSPC): A
Medicare database analysis

S. Freedland

Type: Poster
Abstract Number: 5073

Real-world treatment patterns among
patients diagnosed with metastatic
castration-sensitive prostate cancer
(mCSPC) in community oncology
settings

D. George

Type: Poster
Abstract Number: 5074

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Follow-up of patients with FLT3-mutated
R/R AML in the phase 3 ADMIRAL trial

A. Perl

Type: Poster

Abstract Number: 7013

Zolbetuximab

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Presentation Title

Lead Author

Presentation Details

Phase 2 study of zolbetuximab plus
mFOLFOX6 in claudin 18.2-positive
locally advanced or metastatic gastric or
gastroesophageal junction adenocarcinoma (G/GEJ): ILUSTRO
cohort 2

K. Lee

Type: Publication Only

Abstract Number: e16078

The ASCO (Free ASCO Whitepaper) 2021 Annual Meeting abstracts are available at the ASCO (Free ASCO Whitepaper) Meeting Library.

Enfortumab Vedotin Collaborations
Astellas and Seagen Inc. 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 US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of enfortumab vedotin 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., Kenilworth, NJ, USA.

Enzalutamide 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 global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.