Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024

Rhea-AI Summary

Astellas (OTC:ALPMY) will present eight abstracts, including two oral presentations, at the ESMO Congress 13–17 Sept 2024 in Barcelona.

Highlights include Phase 3 EV-302 results supporting enfortumab vedotin + pembrolizumab as a potential first-line option in previously untreated la/mUC regardless of Nectin-4 expression; 5‑year follow-up data from EV-103 DE/A for cisplatin‑ineligible la/mUC; pooled overall survival data from SPOTLIGHT and GLOW for zolbetuximab in CLDN18.2+ gastric/GEJ cancer; ongoing Phase 2 zolbetuximab pancreatic trial; EMBARK post‑hoc analyses for enzalutamide in hrBCR prostate cancer by age; and early clinical data on ASP3082 (KRAS G12D degrader) and ASP1570 (DGKζ inhibitor).

Positive

• Eight abstracts across approved and investigational oncology programs
• Phase 3 EV-302 supports EV+pembrolizumab as 1L in la/mUC regardless of Nectin-4
• Five-year follow-up from EV-103 shows durable responses in cis-ineligible la/mUC
• Pooled OS data from SPOTLIGHT + GLOW for zolbetuximab in CLDN18.2+ gastric/GEJ

Negative

• Key pipeline assets ASP3082 and ASP1570 remain early-stage (Phase 1/1–2)
• Phase 2 zolbetuximab pancreatic study is ongoing with no definitive outcomes yet

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio and two lead pipeline programs across a broad range of cancer types -

TOKYO, Sept. 11, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September. 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.

Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:
"The data presented at ESMO 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 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 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

 

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.

About PADCEV and the Astellas, Pfizer and Merck Collaboration
Astellas and Pfizer have a clinical collaboration agreement with Merck to evaluate the combination of Astellas' and Pfizer's PADCEV™ (enfortumab vedotin-ejfv) 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., Rahway, NJ, USA (known as MSD outside of the United States and Canada).

About XTANDI 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 commercial agreement to jointly develop and commercialize XTANDI^® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

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SOURCE Astellas Pharma Inc.

FAQ

What did Astellas (ALPMY) announce for ESMO 2024 presentations dated September 13–17, 2024?

Astellas will present eight abstracts, including Phase 3 and long‑term Phase 1/2 data across urothelial, gastric/GEJ, pancreatic, prostate cancers and early pipeline data.

What do EV-302 results mean for Astellas' enfortumab vedotin use in la/mUC (ALPMY)?

EV-302 exploratory analysis supports enfortumab vedotin + pembrolizumab as a first-line advancement across la/mUC subgroups regardless of Nectin-4 expression.

What long-term data did Astellas present for enfortumab vedotin at ESMO 2024 (ALPMY)?

Five-year follow-up from EV-103 DE/A shows durable responses and meaningful survival for first-line EV + pembrolizumab in cisplatin‑ineligible la/mUC.

What were the zolbetuximab updates Astellas shared at ESMO 2024 (ALPMY)?

A pooled final OS analysis from SPOTLIGHT and GLOW in CLDN18.2+ gastric/GEJ was presented, plus an ongoing Phase 2 trial in CLDN18.2+ metastatic pancreatic cancer.

What early‑stage pipeline data did Astellas (ALPMY) report at ESMO 2024?

Phase 1 data for ASP3082 (KRAS G12D degrader) and preliminary preclinical/early clinical data for ASP1570 (DGKζ inhibitor) were presented.