Novartis to Seek Pre-Taxane Label Expansion for Pluvicto® in Second Half of 2024 Following Latest Data from Phase III PSMAfore Trial

Updated findings on overall survival (OS) from a planned evaluation, encompassing around 75% of data, reveal an OS hazard ratio below 1.0 (HR<1.0) within the intent-to-treat (ITT) population, not adjusted for cross-over.

Consistency is observed in radiographic progression-free survival (rPFS) and other secondary efficacy endpoints, aligning with previous interim analyses from 2023.

After an additional 8 months of monitoring, the safety profile of Pluvicto® remains in line with prior interim assessments from 2023.

A comprehensive presentation of the results is scheduled for an upcoming medical congress.

Novartis confirms its intentions to file in H2 2024.


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