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.
Disclaimer:
This investor update may contain forward-looking statements in accordance with the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may include terms such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar expressions, indicating potential marketing approvals, new indications, or labeling for the investigational or approved products discussed in this media update, or potential future revenues from such products. It is advised not to overly rely on these statements.
Such forward-looking statements are based on current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Actual results may vary materially from those set forth in the forward-looking statements should one or more risks or uncertainties materialize, or if underlying assumptions prove incorrect. There is no guarantee that the investigational or approved products discussed in this media update will be submitted or approved for sale, additional indications, or labeling in any market, or at any particular time, nor is there a guarantee of future commercial success.
Our expectations concerning such products may be impacted by various factors, including uncertainties in research and development, regulatory actions or delays, global health care trends, economic conditions, safety concerns, intellectual property issues, prescribing preferences, and other factors detailed in Novartis AG’s current Form 20-F filed with the US Securities and Exchange Commission. The information provided in this media update is current as of the date provided and Novartis does not assume any obligation to update forward-looking statements contained herein due to new information, future events, or other reasons.
