Real-World Data Show Pluvicto Extends PFS in Taxane-Naive mCRPC
Real-world analyses of Novartis' Pluvicto show a median PFS of 13.5 months in taxane-naive mCRPC patients, with better outcomes when used after one ARPI. Additional data indicate subsequent therapies remain effective after Pluvicto, while a separate analysis found gaps in guideline-adherent treatment for mHSPC.
Novartis announced multiple US real-world studies delivering new insights across metastatic prostate cancer care. The analyses utilize data from Novartis' PRECISION platform to evaluate Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) effectiveness and sequencing, and will be presented at the ASCO Genitourinary Cancers Symposium on February 26, 2026.
Real-world use of Pluvicto resulted in a median progression-free survival of 13.5 months (95% CI: 11.7–14.7 months) in men with metastatic castration-resistant prostate cancer who had been treated with ≥1 androgen receptor pathway inhibitor and were taxane-naïve. Patients treated after only 1 ARPI had longer median PFS of 15.8 months (95% CI: 11.7–18.6 months) compared with those who received Pluvicto after multiple ARPIs, who had a median PFS of 12.7 months (95% CI: 10.7–14.0 months). The PSA50 response rates were 62.6% overall, 61.4% in the 1 ARPI group, and 63.8% in the >1 ARPI group.
The real-world findings are consistent with PSMAfore, which supported the approval of Pluvicto for patients with PSMA-positive mCRPC who have been treated with an ARPI and are considered appropriate to delay taxane-based chemotherapy. In PSMAfore, Pluvicto more than doubled median radiographic progression-free survival compared to a change in ARPI (11.6 months vs. 5.6 months) at an updated exploratory analysis.
A second study showed that patients with mCRPC achieved meaningful clinical responses with systemic therapies after discontinuing Pluvicto, including taxane, ARPI, or PARP inhibitor, most of whom had prior exposure to ARPI and chemotherapy. The median PFS for all patients was 8.6 months (95% CI: 7.2–10.1 months); for those receiving subsequent ARPI it was 10.7 months (95% CI: 8.1–19.3 months), and for those receiving subsequent taxane it was 7.2 months (95% CI: 5.9–9.4 months).
A separate analysis of treatment patterns in metastatic hormone-sensitive prostate cancer found that nearly four in ten men (39.2%) received androgen deprivation therapy alone, while just over half (55.5%) received combination ADT plus ARPI, based on data from 43,415 patients treated between 2020 and 2025. The findings indicate that while adoption of guideline-recommended therapy is improving, a significant opportunity remains for patients to receive optimal care.