American Urological Association Annual Meeting 2026 | News | Updates | iPharmaCenter
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Novartis’ Pluvicto Shows Deeper PSA Responses in Hormone-Sensitive Prostate Cancer
Novartis has reported new findings from the PSMAddition trial showing that Pluvicto (lutetium-177 vipivotide tetraxetan), when added to standard therapy, significantly improves prostate-specific antigen (PSA) outcomes in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).
The data indicate that combining Pluvicto with standard of care, comprising an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT), resulted in a 58% reduction in the risk of PSA progression compared with standard treatment alone.
Patients receiving the Pluvicto combination demonstrated both higher response rates and deeper reductions in PSA levels. While over 98% of patients in both treatment groups experienced notable PSA declines, a greater proportion of those treated with Pluvicto achieved very low PSA levels, defined as a nadir below 0.2 ng/mL. These deeper responses were consistently observed at 12, 24, and 48 weeks.
The findings come from the second interim analysis of the ongoing PSMAddition study. In terms of safety, Pluvicto’s profile remained consistent with previous studies, including PSMAfore and VISION. Grade 3 or higher adverse events were reported in 50.7% of patients receiving Pluvicto plus standard therapy, compared with 43% in the standard care group. Common side effects across all grades included dry mouth, fatigue, nausea, hot flushes, and anemia.
PSA progression is considered an early marker of treatment resistance in prostate cancer. Around one-third of patients treated with standard therapy alone fail to achieve undetectable PSA levels. Disease progression to metastatic castration-resistant prostate cancer (mCRPC), which often occurs within about 20 months, is linked to poorer outcomes and a median survival of less than two years.
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