Swiss pharmaceutical giant Novartis (NYSE: NVS) announced the interim results from its Phase III PSMAddition trial, demonstrating significant improvements in radiographic progression-free survival (rPFS) for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) treated with Pluvicto (lutetium (177Lu) vipivotide tetraxetan) plus standard of care (SoC), compared to SoC alone. The results also indicated a positive trend in overall survival (OS).
Clinical Trial Results
The pre-specified interim analysis met its primary endpoint, showing statistically significant and clinically meaningful improvements in rPFS. This marks a significant step forward in the treatment of PSMA-positive mHSPC patients.
Drug Mechanism
Pluvicto is a radioligand therapy (RLT) composed of a targeting ligand bound to the therapeutic radionuclide lutetium-177. It selectively binds to PSMA-expressing prostate cancer cells and emits radiation to damage target cells and neighboring tumor cells.
Market Position
Currently, Pluvicto is the only PSMA-targeted RLT approved outside China for treating PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). This trial further establishes its potential in addressing unmet needs in prostate cancer treatment.-Fineline Info & Tech
