On September 11, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held in Barcelona, Spain on 13-17 September (Press release, Astellas, SEP 11, 2024, View Source [SID1234646508]). Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas’ commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts include data spanning prostate, urothelial, gastric and gastroesophageal junction (GEJ), and pancreatic cancers. Two abstracts feature Phase 1 data presented for the first time from immuno-oncology and targeted protein degradation assets.
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Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:
"The data presented at ESMO (Free ESMO Whitepaper) are an exciting demonstration of the strength of our portfolio and the transformative potential of our pipeline to help deliver outcomes that matter for patients. Astellas has made a long-term commitment to helping people living with hard-to-treat cancers by both investing in next-generation modalities like targeted protein degradation and immuno-oncology, and by maximizing the number of patients that could benefit from our approved medicines."
Highlights at the ESMO (Free ESMO Whitepaper) Congress 2024 include:
Data from the Phase 3 EV-302 study, evaluating Nectin-4 expression and response to first-line treatment of enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression.
Five-year follow-up data from the Phase 1/2b EV-103 DE/A study, analyzing durable responses and meaningful survival to enfortumab vedotin in combination with pembrolizumab in patients with first-line cis-ineligible la/mUC. These results further support the broad suitability, regardless of cis-eligibility, and long-term benefits of this regimen in la/mUC.
Final pooled overall survival data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab plus chemotherapy as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
Updates involving a Phase 2 trial in progress assessing zolbetuximab in combination with gemcitabine and nab-paclitaxel (GN) versus GN monotherapy as first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer.
Phase 3 EMBARK post-hoc analyses, evaluating enzalutamide in combination with leuprolide and as monotherapy versus leuprolide alone in patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer. These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years.
Clinical data from lead pipeline assets: Phase 1 data from ASP3082, the first protein degrader targeting KRAS G12D mutant to enter clinical trials, in patients with advanced pancreatic, colorectal, and non-small cell lung cancer; and preclinical, translational/early clinical data from ASP1570, a novel DGKζ inhibitor, in patients with advanced solid tumors. The results support continued study of these investigational therapies for the treatment of various cancer types.
Astellas Presentations at 2024 ESMO (Free ESMO Whitepaper) Congress
Enfortumab vedotin
Presentation title
Speaker
Presentation details
EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or
Metastatic Urothelial Cancer (la/mUC)
T. Powles
Type: Mini Oral Session
Abstract Number: 1966MO
Date: September 15
Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L)
Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally
Advanced Or Metastatic Urothelial Carcinoma (la/mUC)
J. Rosenberg
Type: Poster
Abstract Number: 1968P
Date: September 15
Epidemiology and treatment patterns of patients with locally advanced or metastatic
urothelial cancer in France: a non-interventional database study
F. Joly
Type: Poster
Abstract Number: 2001P
Date: September 15
Zolbetuximab
Presentation title
Speaker
Presentation details
First-line (1L) zolbetuximab + chemotherapy in patients (pts) with claudin 18.2 (CLDN18.2) +, HER2–, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: A pooled final analysis of SPOTLIGHT + GLOW
Y-K Kang
Type: Poster
Abstract Number: 1438P
Date: September 16
Zolbetuximab With Gemcitabine + 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
Abstract Number: 1532TiP
Date: September 16
Enzalutamide
Presentation title
Speaker
Presentation details
Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post-hoc analysis by age
N. D. Shore
Type: Poster
Abstract Number: 1638P
Date: September 15
Pipeline
Presentation title
Speaker
Presentation details
Phase 1/2 Trial of ASP1570, a Novel Diacylglycerol Kinase ζ Inhibitor, in Patients With Advanced Solid Tumors
D. Olsen
Type: Poster
Abstract Number: 1004P
Date: September 14
Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)
W. Park
Type: Proffered Paper Session
Abstract Number: 608O
Date: September 15