Press Release: 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 PluvictoTM plus standard of

care (SoC) versus SoC alone in PSMA+ mHSPC

-- NATALEE five-year analysis of Kisqali(R) 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(TM) Phase 3 trial of [(177) Lu]Lu-PSMA-617 combined with #LBA6

(lutetium ((177) ADT + ARPI in patients with PSMA-positive metastatic Presidential Symposium 2 (Proffered Paper session)

Lu) vipivotide hormone-sensitive prostate cancer (PSMAddition) October 19, 2025

tetraxetan) 16:30 -- 18:15 CEST

------------------ --------------------------------------------------------------- -----------------------------------------------------

Pluvicto(TM) Associations between quantitative baseline (68) Ga-PSMA-11 #2390P

(lutetium ((177) PET parameters and (177) Lu-PSMA-617 efficacy in the Poster Presentation

Lu) vipivotide PSMAfore Study October 18, 2025

tetraxetan) 09:00 -- 17:00 CEST

------------------ --------------------------------------------------------------- -----------------------------------------------------

Pluvicto(TM) Final analysis of patients treated with [(177) Lu]Lu-PSMA-617 #2389P

(lutetium ((177) in early access program in metastatic castration-resistant Poster Presentation

Lu) vipivotide prostate cancer (mCRPC) in France October 18, 2025

tetraxetan) 09:00 -- 17:00 CEST

------------------ --------------------------------------------------------------- -----------------------------------------------------

[(225) PSMAcTION trial-in-progress: a phase 2/3 randomized #2516TiP

Ac]-PSMA-617 trial of [(225) Ac]Ac-PSMA-617 ((225) Ac-PSMA-617) Poster Presentation

versus standard of care in patients with PSMA-positive October 18, 2025

metastatic castration-resistant prostate cancer who 09:00 -- 17:00 CEST

progressed on or after [(177) Lu]Lu-PSMA therapy

------------------ --------------------------------------------------------------- -----------------------------------------------------

Kisqali(R) Adjuvant ribociclib (RIB) plus nonsteroidal aromatase #LBA14

(ribociclib) inhibitor (NSAI) in patients (pts) with HR+/HER2- Proffered Paper session

early breast cancer (EBC): NATALEE 5-year outcomes October 17, 2025

14:00 -- 15:30 CEST

------------------ --------------------------------------------------------------- -----------------------------------------------------

Kisqali(R) Impact of neoadjuvant chemotherapy (NACT) response #366P

(ribociclib) on clinical outcomes with ribociclib (RIB) in HR+/HER2- Poster Presentation

EBC: a subgroup analysis from the phase 3 NATALEE October 20, 2025

trial 09:00 -- 17:00 CEST

------------------ --------------------------------------------------------------- -----------------------------------------------------

Kisqali(R) A NATALEE data--based machine learning (ML) model #372P

(ribociclib) to predict distant recurrence (DR) and treatment (tx) Poster Presentation

effect in real-world (RW) patients (pts) with HR+/HER2-- October 20, 2025

early breast cancer (EBC) without CDK4/6 inhibitor 09:00 -- 17:00 CEST

(CDK4/6i) tx

------------------ --------------------------------------------------------------- -----------------------------------------------------

Kisqali(R) Real-world characteristics, treatments and outcomes #360P

(ribociclib) of NATALEE and monarchE-eligible HR+/HER2- early breast Poster Presentation

cancer patients in the hospital district of Helsinki October 20, 2025

and Uusimaa (HUS), Finland 09:00 -- 17:00 CEST

------------------ --------------------------------------------------------------- -----------------------------------------------------

Kisqali(R) Risk of Recurrence (ROR) After Neoadjuvant Ribociclib #296O

(ribociclib) Plus ET in Clinically High-Risk ER+/HER2- BC: Preliminary Proffered Paper session

Analysis of the SOLTI-RIBOLARIS Trial 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.

Disclaimer

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