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Astellas To Present Pioneering Advances Across Its Portfolio and Pipeline at ESMO 2025

On October 1, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will present ten abstracts from our portfolio and advancing pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress taking place from 17-21 October 2025, including new data for PADCEV (enfortumab vedotin) plus pembrolizumab in muscle-invasive bladder cancer (MIBC) which will be presented in an ESMO (Free ESMO Whitepaper) Presidential Symposium on 18 October (Press release, Astellas, OCT 1, 2025, View Source [SID1234656373]). In prostate cancer, we are sharing final best-in-class overall survival data for XTANDI (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone sensitive disease, plus encouraging data for our next-generation bispecific T cell engager ASP2138 in solid tumors, demonstrating continued leadership in CLDN18.2-targeted precision medicine.

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Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"Astellas focuses on some of the most complex and devastating cancers. These ESMO (Free ESMO Whitepaper) data demonstrate our ‘bench to bedside’ approach in action – from deep disease biology to measurable improvements in patient outcomes. We’re proud to share breakthrough new survival data in muscle-invasive bladder cancer and overall survival data in hormone sensitive prostate cancer, which reflect potentially practice-changing advances that could transform outcomes for patients who need them most. We also continue to advance innovation in gastric and gastroesophageal junction cancer with new clinical data for our next-generation investigational bispecific T cell engager."

Highlights from Astellas at ESMO (Free ESMO Whitepaper) 2025 will include:

Data from the Phase 3 EV-303 (also known as KEYNOTE-905) clinical trial which will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium, evaluating enfortumab vedotin in combination with pembrolizumab as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy.
Long-term follow-up data from the EV-302 clinical trial exploring the utility of enfortumab vedotin in combination with pembrolizumab for patients with challenging baseline characteristics, including older patients with locally advanced or metastatic urothelial cancer and those with comorbidities such as diabetes and chronic kidney disease.
Final data from the Phase 3 EMBARK trial assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence.
First clinical data from Astellas’ investigational CLDN18.2-targeted, next-generation bispecific CD3 T cell engager ASP2138, both as a monotherapy and in combination with standard of care therapy.
Astellas Presentations at ESMO (Free ESMO Whitepaper) Congress 2025

Enfortumab vedotin

Presentation Title

Presenter

Presentation Details

Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study

C. Vulsteke

Type: Presidential Symposium 1

Abstract Number: LBA2

Date: October 18,
16:52 – 17:04 CEST

Enfortumab vedotin and pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer: An exploratory analysis in older patients and those with comorbidities from EV-302

N. Mar

Type: Poster

Abstract Number: 3073P

Date: October 18,
12:00-12:45 CEST

Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: Results from a cohort of the EV-202 trial

P.L. Swiecicki

Type: Mini oral

Abstract Number: 1329 MO

Date: October 19,
17:38-17:43 CEST

EV-103 Cohort K: Efficacy and safety of enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible pts with previously untreated locally advanced or metastatic urothelial cancer with a median follow-up of ≈3.5 y

T.W. Friedlander

Type: Poster

Abstract Number: 3074P

Date: October 18,
12:00-12:45 CEST

Real-world use of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy in France

A. Fléchon

Type: ePoster

Abstract Number: 3111eP

Date: October 18, 12:00-12:45 CEST

Enzalutamide

Presentation Title

Presenter

Presentation Details

Overall survival in EMBARK, a phase 3 randomised trial of enzalutamide or placebo plus leuprolide and enzalutamide monotherapy in patients with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis

S.J. Freedland

Type: Proffered Paper

Abstract Number: LBA87

Date: October 19,
10:55-11:05 CEST

Baseline features and metastasis-free survival by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis

N.D. Shore

Type: Poster

Abstract Number: 2461P

Date: October 18,
12:00-12:45 CEST

Pipeline

Presentation Title

Presenter

Presentation Details

ASP2138 monotherapy in patients with (CLDN18.2)+, advanced solid tumors: Phase 1/1b trial

K. Shitara

Type: Poster

Abstract Number: 2137P

Date: October 19,
12:00-12:45 CEST

ASP2138 monotherapy or in combination with pembrolizumab and mFOLFOX6 or with ramucirumab and paclitaxel in (CLDN18.2)+ locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: Phase 1/1b trial

F. Dayyani

Type: Poster

Abstract Number: 2136P

Date: October 19,
12:00-12:45 CEST

Phase 1 trial of ASP5541 (PRL-02), a long-acting intramuscular depot injection of abiraterone decanoate, in patients with advanced prostate cancer

J. Avitia

Type: Poster

Abstract Number: 2443P

Date: October 18,
12:00-12:45 CEST

NUCLIDIUM Receives Notice of Allowance for Composition-of-Matter Patent Covering FAP inhibitor-based Radiodiagnostics and Therapeutics in the United States

On October 1, 2025 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent covering the company’s KaliosTM-program (Press release, NUCLIDIUM, OCT 1, 2025, https://nuclidium.com/nuclidium-receives-notice-of-allowance-for-composition-of-matter-patent-covering-fap-inhibitor-based-radiodiagnostics-and-therapeutics-in-the-united-states/ [SID1234656372]). Once issued, the composition-of-matter patent will protect a variety of small molecule inhibitors of the fibroblast activation protein (FAP) that can be used in combination with a range of radionuclides bound with a variety of chelating moieties for the diagnosis and treatment of diseases, including solid tumors. The KaliosTM-program consists of a tumor-targeting FAP inhibitor labelled with a pre-selected copper radioisotope: Copper-61 for diagnostics and Copper-67 for therapeutics. The program is currently in development for the diagnosis and treatment of certain breast and lung cancer indications.

"The Notice of Allowance from the U.S. Patent and Trademark Office is an important milestone for NUCLIDIUM as we continue to advance our best-in-class copper-based radiotheranostics. This initial action from the U.S. Patent office strengthens our intellectual property position in a highly competitive field. It also recognizes the innovation inherent in our approach and supports our long-term goal of addressing unmet needs in oncology, especially in women’s health, through innovative copper-based radiopharmaceuticals. We are committed to building a robust patent portfolio that protects our discoveries and to advancing our copper-based theranostics into clinical evaluation," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.

The expected patent covers a diverse range of inhibitors that target FAP, representing broad protection for Nuclidium’s current and future radiopharmaceuticals and theranostics in its KaliosTM-program. FAP is a membrane-bound serine protease (dipeptidyl peptidase) present in epithelial tumors that make up 80-90% of all cancer cases. It is highly expressed on cancer-associated fibroblasts in the tumor stroma as well as in degenerative tissues or inflamed tissues such as bursitis and fibrosis. These characteristics render FAP an attractive target for cancer diagnosis and treatment. Currently approved FAP-targeted radioligands, labelled with either 68Ga or 18F, have a short half-life, which restricts their ability for delayed imaging to identify and treat smaller metastases and, in addition, limits their possible distribution range after production.

Nuclidium and its collaborators recently published a preclinical study in the European Journal of Nuclear Medicine and Molecular Imaging – Radiopharmacy and Chemistry, highlighting the unique potential of copper-based FAP-targeting PET radiotracers. In the study, [61Cu]Cu-Kalios PET radioligands showed favorable pharmacokinetics, high tumor uptake, and strong tumor-to-background ratios with delayed 4h imaging when compared to established FAP-targeting radiotracers. These findings underscore the clinical potential of 61-copper-based radiopharmaceuticals to improve the temporal imaging range for precise detection of FAP-expressing tumors.

CatalYm Announces First Patient Dosed in Phase 2b Trial Evaluating Visugromab in Combination with Chemoimmunotherapy as First-Line Treatment in Metastatic Non-squamous NSCLC

On September 30, 2025 CatalYm reported that the first patient has been dosed in the randomized Phase 2b GDFATHER-NSCLC-01 trial (NCT07098988) (Press release, Catalym, SEP 30, 2025, View Source [SID1234656364]). The trial investigates the efficacy and safety of the company’s anti-GDF-15 antibody visugromab, in combination with standard-of-care chemoimmunotherapy, compared to placebo plus chemoimmunotherapy, as a first-line treatment for patients with newly diagnosed metastatic non-squamous non-small cell lung cancer (NSQ mNSCLC).

Visugromab is a humanized, monoclonal antibody designed to neutralize Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine that plays a central role in immune suppression and anti-PD-(L)-1 resistance. CatalYm demonstrated visugromab’s therapeutic potential in the exploratory Phase 1/2a GDFATHER trial (NCT04725474), where the combination of visugromab and an anti-PD-1 inhibitor led to deep and durable responses across multiple solid tumor types while maintaining a favorable safety profile. Visugromab also showed potential to mitigate cancer cachexia, enhancing patients’ quality of life and treatment tolerability, which could extend therapy duration. Results from an additional blinded, exploratory phase 2 trial of nivolumab and visugromab or placebo as neoadjuvant treatment in patients with muscle-invasive bladder cancer will be announced at ESMO (Free ESMO Whitepaper) 2025.

"Our clinical trials have clearly shown visugromab’s impact for solid tumor patients in multiple settings," said Scott Clarke, Chief Executive Officer at CatalYm. "Given the strong anti-tumor effect with long durability, we believe that visugromab is uniquely positioned to demonstrate compelling efficacy as part of a first-line treatment regimen. We will explore the full potential of GDF-15 neutralization through our targeted Phase 2b development program across different tumor types, treatment settings and associated conditions like cancer cachexia."

The randomized, blinded, placebo-controlled Phase 2b GDFATHER-NSCLC-01 (GDF-15 Antibody-mediaTed Human Effector Cell Relocation) trial will enroll approximately 107 patients across multiple sites in the US, EU and Switzerland. The trial consists of an initial non-randomized safety run-in, followed by a randomized part. The primary endpoint of the trial is objective response rate (ORR). Key secondary endpoints include duration of response (DOR), complete and partial response rates (CR and PR), progression-free survival (PFS), overall survival (OS), body weight trends as well as safety and tolerability parameters.

"Joining CatalYm at this pivotal stage, I am encouraged by the clear scientific rationale supporting visugromab’s mechanism of action. GDF-15 plays a critical role in shielding tumors from immune attack, limiting the effectiveness of current immunotherapies. This mechanism is particularly relevant in first-line metastatic NCSLC, where many patients fail to respond or relapse early on immunotherapy. This trial marks an important step in evaluating visugromab’s potential to overcome this resistance and improve outcomes in a setting with limited options," said Sujata Rao, MD, Chief Medical Officer at CatalYm.

About NSCLC

Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US1. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma2. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy3, emphasizing the need for innovative approaches to overcome immunotherapy resistance.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

Toragen, Inc. Announces $12 Million Convertible Note Financing and Expansion of Board of Directors

On September 30, 2025 Toragen, Inc., a clinical-stage biotechnology company developing a first-in-class, oral small molecule HPV E5 protein inhibitor targeting cancers caused by the human papillomavirus ("HPV"), reported the successful completion of a $12 million convertible note financing (Press release, Toragen, SEP 30, 2025, View Source [SID1234656363]).

The financing was led by Steven Lebow, who will join Toragen’s Board of Directors along with his designee, Dr. Scott Rasgon. GenHenn Capital also participated with a significant investment and will be represented on the Board by Bill Hagaman, COO of GenHenn Capital. In addition, Cathleen May, PhD, will assume the Board seat of the late Paul Engler, representing the Paul F. and Virginia J. Engler Foundation.

"This financing enables us to advance the next critical steps in developing TGN-S15, our lead candidate, and prepare for our upcoming clinical trial," said Sandra Coufal, MD, CEO of Toragen. "We are grateful for the support of our investors and are excited to welcome four distinguished new members to our Board who bring deep expertise and commitment to our mission of developing an effective treatment for HPV-driven cancers."

The majority of proceeds from this financing will support CMC and IND-enabling studies for TGN-S15.

About Steven E. Lebow

Steven Lebow is widely recognized in the investment banking community for his 21-year tenure as Managing Director at Donaldson, Lufkin & Jenrette (DLJ), where he led the Retail Investment Banking Group and advised clients across the U.S., Europe, and Latin America.

He has been an early investor in companies including Costco, Starbucks, PetSmart, Dick’s Sporting Goods, and Ulta Beauty, generating returns between 100x and 600x and helping drive their combined market capitalization above $600 billion. In recognition of his achievements, Steven was inducted into the DLJ "Hall of Fame" in 1995.

He later co-founded Global Retail Partners, a venture capital firm that became GRP Partners, and has continued to be a prominent figure in finance and investment. Steven earned his BA in Economics and Political Science, magna cum laude and Phi Beta Kappa, from UCLA and an MBA from the Wharton School at the University of Pennsylvania, where he was awarded the Exxon Fellowship.

Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI™ (taletrectinib) for the Adjuvant Treatment of ROS1-Positive Early-Stage Non-Small Cell Lung Cancer

On September 30, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZI (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC) (Press release, Nuvation Bio, SEP 30, 2025, View Source [SID1234656362]).

"While surgical resection is a standard treatment for early-stage non-small cell lung cancer, many patients will unfortunately have a recurrence of their cancer after surgery. Patients with ROS1 fusion-positive cancers need new options in the adjuvant setting beyond chemotherapy, especially as we have seen improved outcomes with targeted therapies in other driver-positive cancers," said Alexander Drilon, M.D., Chief, Early Drug Development, Memorial Sloan Kettering Cancer Center and trial investigator. "With its well-characterized, manageable safety profile and demonstrated efficacy in advanced disease, taletrectinib, I believe, holds promise to help prevent disease recurrence following resection of ROS1 fusion-positive tumors. I look forward to learning more about the potential of taletrectinib in this setting as the trial advances."

Following alignment with the U.S. Food and Drug Administration on study design, TRUST-IV will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China with ROS1+ stage IB, II or IIIA NSCLC who have received surgery for their disease. Patients must not have received adjuvant anticancer therapy except standard postoperative platinum-based doublet chemotherapy. Patients will be randomized 2:1 to receive either taletrectinib or placebo daily. The primary endpoint is disease-free survival as determined by investigator. Primary completion date is estimated to be in 2033.

"Based on the proven efficacy and safety data supporting IBTROZI’s use and approval in advanced ROS1-positive non-small cell lung cancer, we are excited to explore its potential in earlier-stage disease, where targeted therapies are lacking," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "The initiation of this trial, with our first patient in the U.S. now enrolled, marks important momentum with our pipeline as we aim to help more patients with lung cancer stay ahead of their disease."

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 20-30% of patients newly diagnosed with ROS1+ NSCLC have early-stage disease amenable to surgical resection.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, following Priority Review and Breakthrough Therapy Designations for both first- and second-line treatment, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com.

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZITM (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.