BASEL, Switzerland, Sept. 26, 2025 — Novartis announced it will present 34 abstracts from its oncology pipeline at the upcoming European Society for Medical Oncology (ESMO) Congress 2025 in Berlin. Highlights include Phase 3 data for Pluvicto™ in metastatic hormone-sensitive prostate cancer (mHSPC) and a five-year analysis of Kisqali® in early breast cancer (EBC). These studies could help establish new standards of care in two of the most prevalent cancers.
Science Significance
The PSMAddition trial of Pluvicto™ plus standard of care showed promising efficacy and safety over standard care alone, reinforcing the role of radioligand therapy in prostate cancer. Meanwhile, the NATALEE trial’s five-year results for Kisqali® demonstrated durable reduction in risk of recurrence in hormone receptor-positive, HER2-negative breast cancer, offering insight into the long-term benefit of CDK4/6 inhibition. Collectively, these findings showcase the scientific potential to shift treatment paradigms.
Regulatory Significance
By presenting late-stage and confirmatory data at ESMO, Novartis positions both Pluvicto™ and Kisqali® for potential expanded regulatory approvals in earlier disease settings. The recognition of PSMAddition in a Presidential Symposium underscores the strength of the evidence regulators may consider in evaluating label expansions, while long-term Kisqali® data supports global guideline integration.
Business Significance
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Positive data for two flagship oncology drugs could reinforce Novartis’ oncology leadership. Expanding indications for Pluvicto™ and Kisqali® would extend market exclusivity and patient reach, strengthening commercial potential in prostate and breast cancer markets. These results also enhance the company’s competitive position in radioligand therapy and CDK4/6 inhibition.
Patients’ Significance
For patients, these results are highly meaningful. Pluvicto™ may offer earlier use of a targeted radioligand therapy that improves survival outcomes in advanced prostate cancer. Kisqali® provides reassurance of sustained recurrence reduction over five years in breast cancer, potentially improving both survival and quality of life for a broad group of patients.
Policy Significance
For patients, these results are highly meaningful. Pluvicto™ may offer earlier use of a targeted radioligand therapy that improves survival outcomes in advanced prostate cancer. Kisqali® provides reassurance of sustained recurrence reduction over five years in breast cancer, potentially improving both survival and quality of life for a broad group of patients.
Novartis’ upcoming ESMO 2025 presentations underscore its ambition to redefine care in prostate and breast cancer through innovative science. With promising late-stage data for Pluvicto™ and Kisqali®, the company is poised to influence regulatory decisions, strengthen its oncology portfolio, and most importantly, deliver long-term benefits for patients worldwide.
Source: Novartis Press Release
