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Pre-ESMO 2025 Highlights
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Zachary Klaassen, MD, MSc, and Rashid Sayyid, MD, MSc
Rashid Sayyid and Zachary Klaassen preview six high-impact GU oncology abstracts upcoming at ESMO 2025 that could redefine treatment standards. Highlights include the KEYNOTE-905/EV-303 trial offering a potential non-chemotherapy perioperative option for cisplatin-ineligible MIBC, ENZARAD and EMBARK expanding enzalutamide’s role in prostate cancer, and PSMAddition testing early use of lutetium-617 in mHSPC.
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| Novartis to Showcase Transformative Data in Advanced Prostate and Early Breast Cancer at ESMO 2025
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| PRESS RELEASE
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| Novartis will present 34 abstracts at ESMO 2025, featuring key data from Pluvicto™ (lutetium-177 PSMA-617) and Kisqali® (ribociclib) that may redefine standards of care in prostate and breast cancer. The PSMAddition trial, selected for a Presidential Session, highlights Pluvicto plus standard therapy in PSMA-positive mHSPC, while the NATALEE 5-year analysis provides long-term insights into Kisqali’s benefit in early HR+/HER2− breast cancer. Together, these data underscore Novartis’ efforts to advance personalized, life-extending therapies and move transformative treatments into earlier disease settings.
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What To Expect at the Upcoming ESMO 2025 Meeting |
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| Friday, October 17th, 2025 |
| Proffered Paper Session 1: GU Tumours, Renal & Urothelial
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LBA108 – Durvalumab (D) in Combination With Bacillus Calmette-Guérin (BCG) for BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): Final Analysis of the Phase 3, Open-Label, Randomised POTOMAC Trial
Presented By: Maria De Santis, MD, PhD
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| Mini Oral Session: GU Tumours, Prostate, Penile and Testis
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LBA91 – Patient-Reported Outcomes From AMPLITUDE, a Randomized Placebo-Controlled Phase 3 Trial of Niraparib and Abiraterone Acetate Plus Prednisone in mHSPC With Homologous Recombination Repair Mutations
Presented By: Dana E. Rathkopf, M
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2385MO – Translational Analyses of T-Cell Phenotypes and Their Association With Clinical Efficacy in the First-in-Human (FIH) Trial of JNJ-78278343 (Pasritamig) in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Presented By: Karen A. Autio, MD, MSc
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LBA37 – a Phase 2 Study of Avelumab in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-Based Chemotherapy or Progressed on or After Platinum-Based Chemotherapy (ALPACA)
Presented By: Srikala Sridhar, MD, MSc, FRCPC
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| Mini Oral Session 1: GU Tumours, Renal & Urothelial
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3069MO – Health-Related Quality of Life Outcomes From the NIAGARA Trial of Perioperative Durvalumab Plus Neoadjuvant Chemotherapy in Muscle-Invasive Bladder Cancer (MIBC)
Presented By: Michiel S. Van der Heijden, MD, PhD
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LBA112 – Neoadjuvant Gemcitabine Intravesical System (TAR-200) + Cetrelimab (CET) or CET Alone in Patients With Muscle-Invasive Bladder Cancer (MIBC): SunRISe-4 (SR-4) Primary Analysis and Biomarker Results
Presented By: Andrea Necchi, MD
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| Saturday, October 18th, 2025 |
| Proffered Paper Session 2: GU Tumours, Renal & Urothelial
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LBA96 – First-Line Pembrolizumab-Based Regimens for Advanced Clear Cell Renal Cell Carcinoma: KEYMAKER-U03 Substudy 03A
Presented By: Cristina Suarez Rodriguez, MD, PhD
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LBA94 – LenCabo: A Randomized Phase II Multicenter Trial of Lenvatinib Plus Everolimus Versus Cabozantinib in Patients With Metastatic Clear Cell RCC That Progressed on PD-1 Immune Checkpoint Inhibition
Presented By: Andrew W. Hahn, MD
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LBA2 – Perioperative Enfortumab Vedotin Plus Pembrolizumab (Pembro) in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin-Ineligible: The Phase 3 KEYNOTE-905 Study
Presented By: Christof Vulsteke, MD, PhD
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| Sunday, October 19th, 2025 |
| Mini Oral Session 2: GU Tumours, Renal & Urothelial
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2594MO – Association of Circulating Kidney Injury Molecule-1 (KIM-1) Levels With Clinical Outcomes in Advanced Renal Cell Carcinoma (aRCC): Retrospective Analysis of COSMIC-313
Presented By: Wenxin Xu, MD
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| Proffered Paper Session: GU Tumours, Prostate, Penile and Testis
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LBA86 – Randomised Phase 3 Trial of Androgen Deprivation Therapy (ADT) With Radiation Therapy With or Without Enzalutamide for High Risk, Clinically Localised Prostate Cancer: ENZARAD (ANZUP 1303)
Presented By: Paul L. Nguyen, MD, MBA
LBA88 – Final Results From PRESTO: A Phase 3 Open-Label Study of Combined Androgen Blockade in Patients (Pts) With High-Risk Biochemically Relapsed Prostate Cancer (BRPC) (AFT-19)
Presented By: Rahul Aggarwal, MD
LBA87 – Overall Survival With Enzalutamide in Biochemically Recurrent Prostate Cancer
Presented By: Neal Shore, MD, FACS
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2383O – a Phase 3 Study of Capivasertib (Capi) + Abiraterone (Abi) vs Placebo (Pbo) + Abi in Patients (Pts) With PTEN Deficient De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): CAPItello-281
Presented By: Karim Fizazi, MD
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LBA6 – Phase 3 Trial of [177Lu]Lu-PSMA-617 Combined With ADT + ARPI in Patients With PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer (PSMAddition)
Presented By: Scott T. Tagawa, M.D., MS, FACP, FASCO
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| Monday, October 20th, 2025 |
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LBA8 – IMvigor011: A Phase 3 Trial of Circulating Tumour (ct)DNA-Guided Adjuvant Atezolizumab vs Placebo in Muscle-Invasive Bladder Cancer
Presented By: Thomas Powles, MBBS, MRCP, MD
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