Swiss pharmaceutical giant Novartis (NYSE: NVS) has released encouraging data from a Phase III study for its radioligand therapy (RLT) Pluvicto (177Lu vipivotide tetraxetan). The study focused on patients with prostate-specific membrane antigen (PSMA)-positive progressive metastatic castration-resistant prostate cancer (mCRPC), a challenging form of the disease.
Primary Endpoint and Risk Reduction
The trial successfully met its primary endpoint, demonstrating a significant benefit in radiographic progression-free survival (rPFS). Pluvicto showed a remarkable reduction in risk by 59% compared to an androgen receptor pathway inhibitor (ARPI) control, highlighting its potential as a transformative treatment option.
Efficacy Outcomes and Response Rates
In addition to the primary endpoint, the study reported other favorable efficacy outcomes. There was a 2.5-fold increase in the rate of patients achieving a prostate-specific antigen (PSA) decline of at least 50%. The objective response rate (ORR) and duration of response (DOR) also saw substantial improvements, increasing from 14.9% to 50.7% and from 10.1 months to 13.6 months, respectively.-Fineline Info & Tech
