On May 12, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that will share new research during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress from June 9-12 (Press release, Astellas, MAY 12, 2022, View Source [SID1234614318]). A total of 13 abstracts from the company’s expanding portfolio of approved and investigational therapies will be presented across both meetings, underscoring the company’s commitment to advancing treatment options for advanced and rare cancers, including prostate, pancreatic and urothelial cancer, as well as acute myeloid leukemia (AML).
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"While a robust Phase 3 clinical trial program in gastric/gastroesophageal junction cancer for our investigational therapy zolbetuximab is well underway, the ASCO (Free ASCO Whitepaper) Annual Meeting will include the first trial-in-progress presentation from our expanded Phase 2 clinical trial in Claudin 18.2-positive pancreatic cancer," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The progress of these clinical studies reflects our enthusiasm to continue investigating the potential to benefit patients by targeting the emerging Claudin 18.2 biomarker."
"At Astellas, our mission is to not only advance innovative science, but to create value for patients and the oncology community," said Erhan Berrak, M.D., Vice President of Global Medical Affairs, Oncology, Astellas. "Our advanced prostate cancer data at ASCO (Free ASCO Whitepaper), which range from new analyses of our ARCHES pivotal trial in metastatic hormone-sensitive prostate cancer to data on patient preferences and prescriber treatment decisions, will help inform discussions between patients and providers about novel hormone therapies."
Highlights at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:
An overview of the expanded Phase 2 open-label, randomized study of zolbetuximab in combination with nab-paclitaxel and gemcitabine as an investigational first-line treatment for patients with Claudin 18.2-positive metastatic pancreatic cancer
Long-term (24-month) data from the Phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor
Four post-hoc analyses from the Phase 3 ARCHES study, which compared enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Highlights at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress include:
Encore data from the COMMODORE Phase 3 confirmatory study of gilteritinib versus salvage chemotherapy in FLT3 mutation-positive relapsed or refractory AML in China and other countries
An overview of the CLEVO non-interventional investigational study of FLT3 mutation frequency in patients with AML in Europe and the U.S.
Astellas Presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting
Enfortumab Vedotin
Presentation Title
Lead Author
Presentation Details
Long-term outcomes in EV-301: 24-month findings from the Phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma
J. Rosenberg
Type: Poster Discussion
Abstract Number: 4516
Date: Saturday, June 4, 2022
Poster Session: Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 – 4:15 p.m. CDT
Poster Discussion Session: Genitourinary Cancer – Kidney and Bladder
Presentation: 4:30 – 6 p.m. CDT
Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling
M. Galsky
Type: Poster Presentation
Abstract Number: 4575
Date: Saturday, June 4, 2022
Poster Session: Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 – 4:15 p.m. CDT
Real-world treatment patterns and clinical outcomes with first-line therapy in cisplatin-eligible and ineligible patients with advanced urothelial carcinoma
G. Sonpavde
Type: Poster Presentation
Abstract Number: 4565
Date: Saturday, June 4, 2022
Poster Session: Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 – 4:15 p.m. CDT
Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible
D. Petrylak
Type: Poster Presentation
Abstract Number: 4582
Date: Saturday, June 4, 2022
Poster Session: Genitourinary Cancer – Kidney and Bladder
Presentation: 1:15 – 4:15 p.m. CDT
Enzalutamide
Presentation Title
Lead Author
Presentation Details
Radiographic progression in the absence of prostate-specific antigen (PSA) progression in patients with metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analysis of ARCHES
A. Armstrong
Type: Poster Presentation
Abstract Number: 5072
Date: Monday, June 6, 2022
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 – 4:15 p.m. CDT
Prevalence of DNA damage repair (DDR) alterations in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide (ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT): ARCHES post hoc analysis
A. Azad
Type: Poster Presentation
Abstract Number: 5074
Date: Monday, June 6, 2022
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 – 4:15 p.m. CDT
The association of germline HSD3B1 genotype with outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without enzalutamide (ENZA) [ARCHES]
N. Sharifi
Type: Poster Presentation
Abstract Number: 5022
Date: Monday, June 6, 2022
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 – 4:15 p.m. CDT
Clinical outcomes and safety of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) in patients aged <75 and ≥75 years: ARCHES post hoc analysis
R. Szmulewitz
Type: Poster Presentation
Abstract Number: 5069
Date: Monday, June 6, 2022
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 – 4:15 p.m. CDT
Reasons for oncologist and urologist treatment choice in metastatic castration-sensitive prostate cancer (mCSPC): A physician survey linked to patient chart reviews in the United States
S. Freedland
Type: Poster presentation
Abstract Number: 5065
Date: Monday, June 6, 2022
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Presentation: 1:15 – 4:15 p.m. CDT
Patient preferences for treatment and outcomes in hormone-sensitive prostate cancer (HSPC)
D. George
Type: Abstract publication
Abstract Number: e18757
Zolbetuximab
Presentation Title
Lead Author
Presentation Details
Zolbetuximab plus gemcitabine and nab-paclitaxel (GN) in first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2, open-label, randomized study
W. Park
Type: Poster Presentation
Abstract Number: TPS4186
Date: Saturday, June 4, 2022
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presentation: 8 – 11 a.m. CDT
Astellas Presentations at EHA (Free EHA Whitepaper) 2022 Hybrid Congress
Gilteritinib
Presentation Title
Lead Author
Presentation Details
CLEVO: a non-interventional study to investigate clonal evolution of FMS-like tyrosine kinase 3 (FLT3) gene mutations during disease progression in patients with acute myeloid leukemia
P. Vyas
Type: Abstract publication
Abstract Number: PB1834
Gilteritinib versus salvage chemotherapy for relapsed/refractory FLT3-mutated acute myeloid leukemia: a Phase 3, randomized, multicenter, open-label trial in Asia
J. Wang
Type: Poster session
Abstract Number: P554
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 US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.
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.