2. UroToday Home
  3. Transformative Evidence
  4. PSMAddition: Phase 3 Trial of [177lu]Lu-PSMA-617 Plus Standard of Care (SoC) vs. Soc Alone in Patients with Metastatic Hormone-Sensitive Prostate Cancer
  5. Articles
  6. UroToday
  7. Prostate Cancer

PSMAddition Data Show Novartis Pluvicto™ Delays Progression to End-Stage Prostate Cancer

Reno, Nevada (UroToday.com) -- Novartis presents new Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) data from the Phase III PSMAddition trial in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025.

The key findings from these data include:

  • Pluvicto™ plus standard of care (ARPI + ADT) significantly reduced risk of progression or death by 28% (HR 0.72) versus SoC alone, with positive trend in OS (HR 0.84) in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC)1
  • Most patients with mHSPC progress to metastatic castration-resistant prostate cancer, underscoring urgent need for new therapies that can reduce risk of progression in earlier disease settings2,3
  • The safety profile and tolerability of Pluvicto in this third positive Phase III study were consistent with its established profile in PSMAfore and VISION trials1,4,5
  • Novartis plans to submit to regulatory authorities by end of year; potential approval would double the number of patients eligible for Pluvicto and further establish its efficacy in metastatic prostate cancer settings

Pluvicto plus standard of care (SoC) (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), reducing the risk of radiographic progression or death by 28% (HR 0.72; 95% CI: 0.58, 0.90) versus SoC alone in patients with prostate-specific membrane antigen (PSMA)+ metastatic hormone-sensitive prostate cancer (mHSPC).1

Results also show an early positive trend in overall survival (OS) in patients treated with Pluvicto plus SoC (HR 0.84; 95% CI: 0.63, 1.13); follow-up will continue until data are mature.1 More patients achieved a complete response versus SoC alone (57.1% vs. 42.3%) and the overall response rate (ORR) was numerically higher in the Pluvicto plus SoC arm (85.3% vs. 80.8%).1 Pluvicto delayed time to progression to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.70; 95% CI: 0.58, 0.84)1. The rPFS benefit was consistent across pre-specified subgroups.1

“In metastatic prostate cancer, choosing the most efficacious treatment early is crucial, even at initial diagnosis,” said Scott T. Tagawa, MD, a professor of medicine at Weill Cornell Medicine and a medical oncologist at NewYork-Presbyterian/Weill Cornell Medical Center. “These findings suggest that combining 177Lu-PSMA-617 with standard of care hormonal therapy offers patients more time without disease progression, a safety profile with adverse events that are most often low grade and managed with supportive care, and an encouraging trend in overall survival.”
“These results reinforce the potential for Pluvicto, a radioligand therapy that delivers treatment directly to target cells, to change how we treat metastatic prostate cancer,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. “With significant benefit now shown across multiple disease stages, Pluvicto is redefining the standard of care. The strength of these results reflects our deep commitment to patients with prostate cancer and our leadership in radioligand therapy.”

The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION.1,4,5 Grade ≥3 adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone.1 The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia.1

PSMAddition marks the third positive Phase III trial with Pluvicto.1,4,5 Building on the significant benefit demonstrated in PSMAfore, which led to the US Food and Drug Administration (FDA) approval in pre-taxane mCRPC in March 2025, these new results strengthen the evidence base for Pluvicto and demonstrate its potential to improve outcomes in an even earlier stage of metastatic prostate cancer.1,4,6 Novartis plans to submit these data to regulatory authorities before end of year.

References:

  1. Novartis. Data on file.
  2. Hussain M, Fizazi K, Shore ND, et al. Metastatic hormone-sensitive prostate cancer and combination treatment outcomes. JAMA Oncol. 2024;10(6):807-820.
  3. Kulasegaran T, Oliveira N. Metastatic castration-resistant prostate cancer: advances in treatment and symptom management. Curr Treat Options Oncol. 2024;25(7):914-931.
  4. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. Lancet. 2024. doi:10.1016/S0140-6736(24)01653-2.
  5. Sartor O, de Bono J, Chi KN, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322.
  6. Pluvicto [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2025.
Source: Novartis. (2025). PSMAddition Data Show Novartis Pluvicto™ Delays Progression to End-Stage Prostate Cancer [Press release]. https://www.novartis.com/news/media-releases/psmaddition-data-show-novartis-pluvictotm-delays-progression-end-stage-prostate-cancer. 

Related Content:

ESMO 2025: Phase III Trial of [177Lu]Lu-PSMA-617 Combined with ADT + ARPI in Patients with PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer (PSMAddition)
ESMO 2025: Discussant – Phase III Trial of [177Lu]Lu-PSMA-617 Combined with ADT + ARPI in Patients with PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer (PSMAddition)