On May 17, 2026 Novartis reported new data from PSMAddition demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) in PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC). Data were presented as a rapid oral presentation at the American Urological Association Annual Meeting 2026.
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Results show that patients treated with Pluvicto experienced a higher frequency and depth of PSA response when combined with SoC (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) compared to SoC alone. Risk of PSA progression was 58% lower (HR 0.42; 95% CI: 0.30-0.59) in patients treated with Pluvicto plus SoC compared to SoC alone.
"Our goal in hormone-sensitive prostate cancer is to attack and delay the cancer before it develops resistance," said Fred Saad, Professor and Chairman, Department of Surgery, University of Montreal. "The deep and durable PSA response observed by combining 177Lu-PSMA-617 with today’s standard of care, together with earlier reported rPFS data, suggest that treatment intensification with radioligand therapy may help patients delay disease progression."
Nearly all patients (>98%) in both arms had substantial declines in PSA levels. However, more patients treated with Pluvicto plus SoC achieved a deep PSA reduction than those treated with SoC alone, as measured by PSA nadir of <0.2 ng/mL.
Time from randomization Patients with PSA <0.2 ng/mL
Pluvicto + ARPI + ADT ARPI + ADT
Week 12 47.6% (235/494) 37.7% (169/448)
Week 24 73.7% (334/453) 59.7% (250/419)
Week 48 87.4% (320/366) 74.9% (295/394)
These results were observed at the second interim analysis for PSMAddition. The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION. Grade ≥3 adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia.
"These data show that combining Pluvicto with today’s standard of care resulted in deeper PSA responses than ADT plus ARPI alone," said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. "As the field moves toward more precision-based approaches and earlier treatment intensification in mHSPC, we are encouraged by the potential for Pluvicto to redefine the standard of care across metastatic prostate cancer."
Novartis has filed regulatory submissions in the United States, China and Japan, with first decisions expected in H2 2026.
PSA progression signals disease resistance
PSA progression can be an early indicator of emerging disease resistance, and approximately one-third of patients do not achieve undetectable PSA levels with SOC alone3. Progression to mCRPC, which typically happens within 20 months of diagnosis, is associated with significantly worse outcomes and a life expectancy less than two years4-7. Approximately 186,000 men are diagnosed with mHSPC each year across the US, China, Japan, France, Germany, Italy, Spain and the United Kingdom1.
About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.
Pluvicto is the only PSMA-targeted agent approved for PSMA+ mCRPC and is the first RLT to demonstrate a clinical benefit for patients with PSMA+ mHSPC in a Phase III trial. Novartis is investigating Pluvicto in oligometastatic prostate cancer, an earlier stage of disease, in the PSMA-DC trial (NCT05939414).
Educational Resources for RLT
To support the integration and safe administration of Novartis RLT products across urology and oncology, Novartis created the RLT Institute. The Institute provides educational resources on theranostics, safety and licensing, facilities and equipment, and clinical workflows to support urologists, oncologists and multidisciplinary teams as they prepare for and integrate RLT into patient care.
(Press release, Novartis, MAY 17, 2026, View Source [SID1234665811])