New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic hormone-sensitive prostate cancer

• More durable, deeper PSA response in patients treated with Pluvicto plus standard of care (ARPI + ADT) vs. SoC alone
  
  
• Deep PSA reduction higher in patients receiving Pluvicto combination vs. SoC at 12, 24 and 48 weeks
  
  
• sNDA filed in US, China and Japan; decisions expected H2 2026
  

Basel, May 17, 2026 – Novartis today announced 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.

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 years^4-7. 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.

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References

1. Novartis data on file.
2. Saad F et al. Prostate-specific antigen endpoints in the phase 3 PSMAddition study of [177Lu]Lu-PSMA-617
   (177Lu-PSMA-617) combined with ADT and ARPI in patients with PSMA-positive (PSMA+) metastatic hormone-sensitive prostate cancer (mHSPC). Presented at the American Urological Association Annual Meeting 2026, May 17, 2026.
3. Armstrong AJ, et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986.
4. Verry C, Vincendeau S, Massetti M, et al. Pattern of clinical progression until metastatic castration-resistant prostate cancer: an epidemiological study from the European Prostate Cancer Registry. Target Oncol. 2022;17(4):441-451.
5. Wenzel M, Siech C, Hoeh B, et al. Contemporary treatment patterns and oncological outcomes of metastatic hormone-sensitive prostate cancer and first- to sixth- line metastatic castration-resistant prostate cancer patients. Eur Urol Open Sci. 2024;66:46-54.
6. Freedland SJ, Davis M, Epstein AJ, Arondekar B, Ivanova JI. Real-world treatment patterns and overall survival among men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in the US Medicare population. Prostate Cancer Prostatic Dis. 2024;27(2):327-333.
7. Holmstrom S, Naidoo S, Turnbull J, et al. Symptoms and impacts in metastatic castration-resistant prostate cancer: qualitative findings from patient and physician interviews. Patient. 2019;12(1):57-67.
   
   

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