Novartis to showcase transformative data in advanced prostate and early breast cancer at ESMO 2025

• Key data from PSMAddition has been selected for a Presidential session; data to showcase the efficacy and safety of Pluvicto^TM plus standard of care (SoC) versus SoC alone in PSMA+ mHSPC
  
  
• NATALEE five-year analysis of Kisqali^® to provide further long-term insights into risk of recurrence reduction in a broad EBC patient population
  
  
• New data for Pluvicto in prostate cancer and Kisqali in breast cancer strengthen the profiles of both medicines, with promise for new SoC in earlier disease settings
  
  

Basel, September 26, 2025 – Novartis will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin (October 17-21, 2025).

“We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients,” said Dushen Chetty, PhD, Global Head of Oncology Development, Novartis, Ad Interim. “Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy.”

Key highlights of data accepted by ESMO include:

Medicine	Abstract title	Abstract Number/ Presentation Details
Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan)	Phase 3 trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition)	#LBA6 Presidential Symposium 2 (Proffered Paper session) October 19, 2025 16:30 – 18:15 CEST
Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan)	Associations between quantitative baseline 68Ga-PSMA-11 PET parameters and 177Lu-PSMA-617 efficacy in the PSMAfore Study	#2390P Poster Presentation October 18, 2025 09:00 – 17:00 CEST
Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan)	Final analysis of patients treated with [177Lu]Lu-PSMA-617 in early access program in metastatic castration-resistant prostate cancer (mCRPC) in France	#2389P Poster Presentation October 18, 2025 09:00 – 17:00 CEST
[225Ac]-PSMA-617	PSMAcTION trial-in-progress: a phase 2/3 randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy	#2516TiP Poster Presentation October 18, 2025 09:00 – 17:00 CEST
Kisqali® (ribociclib)	Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes	#LBA14 Proffered Paper session October 17, 2025 14:00 – 15:30 CEST
Kisqali® (ribociclib)	Impact of neoadjuvant chemotherapy (NACT) response on clinical outcomes with ribociclib (RIB) in HR+/HER2− EBC: a subgroup analysis from the phase 3 NATALEE trial	#366P Poster Presentation October 20, 2025 09:00 – 17:00 CEST
Kisqali® (ribociclib)	A NATALEE data–based machine learning (ML) model to predict distant recurrence (DR) and treatment (tx) effect in real-world (RW) patients (pts) with HR+/HER2– early breast cancer (EBC) without CDK4/6 inhibitor (CDK4/6i) tx	#372P Poster Presentation October 20, 2025 09:00 – 17:00 CEST
Kisqali® (ribociclib)	Real-world characteristics, treatments and outcomes of NATALEE and monarchE-eligible HR+/HER2- early breast cancer patients in the hospital district of Helsinki and Uusimaa (HUS), Finland	#360P Poster Presentation October 20, 2025 09:00 – 17:00 CEST
Kisqali® (ribociclib)	Risk of Recurrence (ROR) After Neoadjuvant Ribociclib Plus ET in Clinically High-Risk ER+/HER2− BC: Preliminary Analysis of the SOLTI-RIBOLARIS Trial	#296O Proffered Paper session October 17, 2025 14:00 – 15:30 CEST

Novartis in oncology
The Novartis oncology strategy focuses on people living with cancer and those who care for them, from loved ones to clinical care teams, including their providers. For the past 30+ years, the aim has been to extend and improve lives by discovering differentiated, innovative and practice-changing medicines for patients.

As Novartis reimagines medicine, it collaborates with a wide range of patient advocacy groups and supports education, early cancer screening and diagnosis. With approximately 35 research and development projects across solid tumors, hematology and radioligand therapy (RLT), Novartis is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need.

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