- 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® 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
“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 |
Source: Novartis. (2025). Novartis to Showcase Transformative Data in Advanced Prostate and Early Breast Cancer at ESMO 2025 [Press release]. https://www.novartis.com/news/media-releases/novartis-showcase-transformative-data-advanced-prostate-and-early-breast-cancer-esmo-2025.