On Monday, Novartis (NYSE:NVS) announced positive topline results from the Phase III PSMAddition trial, which showed that its targeted radioligand therapy/RLT, Pluvicto (lutetium (177Lu) vipivotide tetraxetan), significantly slowed prostate cancer progression in an earlier disease setting.
A doctor holding a microscope in front of a laboratory sample of healthcare products.
The study evaluated Pluvicto combined with standard of care (SoC – androgen receptor pathway inhibitor/ARPI therapy and androgen deprivation therapy/ADT) versus SoC alone. The study met its primary endpoint by showing a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The trial also indicated a positive trend in overall survival. This marks the third positive Phase III readout for Pluvicto, which follows the VISION and PSMAfore studies.
Pluvicto is currently approved for metastatic castration-resistant prostate cancer (mCRPC). Given that nearly all mHSPC patients eventually progress to mCRPC, these new data suggest its potential for use in an earlier disease stage, which would address a significant unmet medical need. Novartis plans to present the detailed results at an upcoming medical meeting. Based on FDA feedback, the company will then submit for regulatory review for wider use in H2 2025.
Novartis researches, develops, manufactures, distributes, markets, and sells pharmaceutical medicines in Switzerland and internationally. The company focuses on therapeutic areas like cardiovascular, renal & metabolic, immunology, neuroscience, oncology, and hematology.
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This article is originally published at Insider Monkey.
