Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer

• Key data from the Phase III PSMAfore trial has been selected for a Presidential session; PSMAfore is investigating Pluvicto^TM (INN: lutetium (177Lu) vipivotide tetraxetan) in the pre-chemotherapy setting for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)

• New analysis of key subgroups of clinical interest from NATALEE reinforces the potential of Kisqali^® (ribociclib) plus endocrine therapy (ET) to consistently reduce the risk of cancer recurrence across a broad population of patients with stage II and stage III HR+/HER2- early breast cancer, including those with no nodal involvement

Basel, October 5, 2023 — Novartis will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) Congress 2023, highlighting latest developments from across its oncology portfolio and addressing unmet needs of patients diagnosed with some of the most prevalent cancers, including prostate and breast.

Key data from the Phase III PSMAfore trial investigating Pluvicto^TM (INN: lutetium (177Lu) vipivotide tetraxetan) as an earlier line of treatment for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have not been exposed to a taxane-containing regimen will be presented. PSMAfore met its primary endpoint of radiographic progression-free survival (rPFS) in December 2022, and data collection for the key secondary endpoint of overall survival (OS) is ongoing. Data from the primary rPFS analysis and the second interim OS analysis will be presented at ESMO.

“Metastatic prostate cancer has a five-year survival rate of about 30 percent, and patients who progress despite taking androgen-receptor pathway inhibitor therapy need additional treatment options with reduced toxicity,” said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development at Novartis. “Pluvicto is the first and only approved, targeted radioligand therapy to significantly extend life in patients with mCRPC who have been treated with ARPI therapy and taxane-based chemotherapy. We look forward to sharing new data from the Phase III PSMAfore trial, which adds to the growing body of evidence demonstrating the potential of our radioligand therapy platform in earlier lines of therapy.”

Key highlights of data accepted by ESMO include:

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*Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.