By VETTAPHARMA reporter – Derek Roche: Novartis announced updated real-world evidence showing that Pluvicto™ (lutetium (¹⁷⁷Lu) vipivotide tetraxetan), a PSMA-targeted radioligand therapy, delivers clinically meaningful outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) when used before chemotherapy in routine practice. The real-world findings reinforce previously reported clinical data and will be presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium later this week.
Analyses from the Novartis PRECISION platform showed a median progression-free survival (PFS) of 13.5 months (95% CI: 11.7–14.7) among men with PSMA-positive mCRPC who received Pluvicto after treatment with at least one androgen receptor pathway inhibitor (ARPI) and were taxane-naïve. When Pluvicto was administered after only one ARPI, median PFS extended to 15.8 months (95% CI: 11.7–18.6), compared with 12.7 months (95% CI: 10.7–14.0) in patients treated after multiple ARPI therapies.
In addition to longer median PFS, the real-world data showed that 62.6% of patients overall achieved a ≥50% decline in prostate-specific antigen (PSA50) levels from baseline, a commonly used marker of therapeutic response in advanced prostate cancer. Response rates were similar across subgroups whether Pluvicto was given after one or multiple ARPIs.
Novartis noted that these real-world outcomes are consistent with results from the pivotal Phase III PSMAfore study, which supported regulatory approval of Pluvicto for use in PSMA-positive mCRPC before the need for taxane-based chemotherapy. Pluvicto’s performance in both datasets highlights its potential to provide meaningful clinical benefit and supports its earlier use in the treatment sequence for eligible patients.
