New PSMA PET Research Shows Merits of Pluvicto in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Pluvicto in combination with the standard of care led to a 28 percent reduction in the risk of radiographic progression or death in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to results from the phase III PSMAddition trial presented at the European Society for Medical Oncology (ESMO) conference.
New PSMA PET research presented at the European Society for Medical Oncology (ESMO) conference revealed that the combination of Pluvicto (lutetium(177Lu) vipvotide tetraxetan) and standard of care led to significantly reduced risk for radiographic progression and death in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
For the randomized study, researchers compared the standard of care (SoC) combination of an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT) to the use of Pluvicto and SoC in a cohort of 1,144 patients. All patients in the cohort had mHSPC, were treatment-naïve or had minimal treatment for < 45 days, and had > 1 PSMA-positive metastatic lesion, according to the study.
In comparison to the SoC combination of an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT) for mHSPC, researchers found that the use of Pluvicto and SoC:
• led to a 28 percent reduction in the risk of radiographic progression or death;
• delayed time of progression to metastatic castration-resistant prostate cancer (mCRPC) by 30 percent; and
• led to a 16 percent improvement in overall survival (OS) rates in preliminary findings.
The study authors noted a higher percentage of grade > 3 adverse events in the Pluvicto/SoC arm of the study (50.7 percent vs. 43 percent with SoC). The researchers also pointed out that the most common all-grade adverse events ranged from dry mouth and nausea to fatigue and anemia.
“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,” noted lead study author Scott T. Tagawa, M.D., a professor of medicine at Weill Cornell Medicine and a medical oncologist at New York-Presbyterian/Weill Cornell Medical Center.
The combination of Pluvicto and SoC also facilitated a 14.8 percent higher complete response rate in patients with mHSPC (57.1 percent vs. 42.3 percent) and a 4.5 percent higher overall response rate (85.3 percent vs. 80.8 percent) in contrast to SoC alone, according to the study authors.
References
- Tagawa ST, Sartor O, Piulats JM, et al. Phase III trial of (177Lu)Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). Presented at the European Society for Medical Oncology (ESMO) Congress 2025, Oct.17-21, 2025, Berlin, Germany. Available at: https://www.esmo.org/meeting-calendar/esmo-congress-2025 . Accessed October 20, 2025.
- Novartis. PSMAddition data show Novartis Pluvicto delays progression to end-stage prostate cancer. Available at: https://www.novartis.com/us-en/news/media-releases/psmaddition-data-show-novartis-pluvictotm-delays-progression-end-stage-prostate-cancer . Published October 19, 2025. Accessed October 20, 2025.
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