Novartis Shares Positive Topline Results from Pluvicto Trial for Prostate Cancer

Novartis has announced topline results from the Phase III PSMAddition trial, where Pluvicto (lutetium-177 vipivotide tetraxetan) combined with standard of care (SoC) significantly improved radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). A positive trend in overall survival (OS) was also noted. The SoC included androgen receptor pathway inhibitors and androgen deprivation therapy. This marks the third successful Phase III trial for Pluvicto, following VISION and PSMAfore. Patients in the SoC group may receive Pluvicto upon disease progression. Detailed findings will be presented at an upcoming medical meeting and submitted for regulatory review later this year. The U.S. FDA recently approved Pluvicto for earlier use in metastatic castration-resistant prostate cancer (mCRPC), based on PSMAfore data. Novartis also recently reported positive results from a Phase III trial of OAV101, an investigational therapy for spinal muscular atrophy in children aged two to under 18 years.

10-06-2025