News|Articles|March 18, 2026

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Lutetium Lu 177 Vipivotide Tetraxetan Remains Effective After Sipuleucel-T in mCRPC

Author(s)Kyle Doherty
Fact checked by: Caroline Seymour
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Key Takeaways

  • Median OS reached 19.8 months and median PFS 15.2 months in 290 sipuleucel-T–pretreated patients receiving 177Lu-PSMA-617, aligning with VISION and PSMAfore benchmarks.
  • Biochemical activity was robust among PSA-evaluable patients, with ≥50%, ≥80%, and ≥90% PSA declines in 60.4%, 41.7%, and 32.6%, respectively.
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Lutetium Lu 177 vipivotide tetraxetan was active after treatment with sipuleucel-T in real-world mCRPC.

Patients with metastatic castration-resistant prostate cancer (mCRPC) who received lutetium Lu 177 vipivotide tetraxetan (Pluvicto) following treatment with sipuleucel-T (Provenge) responded well to the radioligand therapy, according to data from a real-world analysis presented during the 2026 Genitourinary Cancers Symposium.1

Findings from the study revealed that the median overall survival (OS) and progression-free survival (PFS) values among patients in the study population (n = 290) were 19.8 months (95% CI, 15.3-23.2) and 15.2 months (95% CI, 11.6-19.4), respectively. Patients with prostate-specific antigen (PSA) values that were available for both the baseline and follow-up periods (n = 144) achieved a PSA reduction of at least 50%, 80%, or 90% at respective rates of 60.4%, 41.7%, and 32.6%.

“In this real-world analysis, the effectiveness of [lutetium Lu 177 vipivotide tetraxetan] in patients previously treated with sipuleucel-T was broadly similar to that observed in the phase 3 VISION [NCT03511664] and PSMAfore [NCT04689828] clinical trials,” Neil D. Shore, MD, FACS, the medical director for the Carolina Urologic Research Center in Myrtle Beach, South Carolina, and his coauthors wrote in a poster presentation of the data.

In March 2025, the FDA expanded the indication of lutetium Lu 177 vipivotide tetraxetan to include adult patients with prostate-specific membrane antigen–positive mCRPC who have been treated with an androgen receptor (AR) pathway inhibitor and are considered appropriate to delay taxane-based chemotherapy.2

Real-World Treatment With Lutetium Lu 177 Vipivotide Tetraxetan After Sipuleucel-T in mCRPC

  • Patients with mCRPC responded well to lutetium Lu 177 vipivotide tetraxetan after receiving sipuleucel-T.
  • The median OS was 19.8 months (95% CI, 15.3-23.2) and the median PFS was 15.2 months (95% CI, 11.6-19.4).
  • The PSA50, PSA80, and PSA90 response rates were 60.4%, 41.7%, and 32.6%, respectively.

How was the real-world analysis conducted?

The retrospective, observational study included adult male patients with clinician-documented mCRPC who had received at least 1 dose of lutetium Lu 177 vipivotide tetraxetan from March 23, 2022, to June 27, 2025, and had a history of treatment with sipuleucel-T.1 The study authors extracted data from the PRostatE Cancer dISease observatiON (PRECISION) data platform and the index date was the date of lutetium Lu 177 vipivotide tetraxetan initiation.

At baseline, the median age was 74.0 years (IQR, 69.0-79.0). Most patients were White (71.7%), had an unknown marital status (53.8%), were treated in a community practice (83.5%), were treated by a medical oncologist (68.3%), had a Gleason score of at least 8 (57.2%), and had bone metastases (76.9%). The median prostate-specific antigen level was 35.3 ng/mL (IQR, 10-99.2).

What other treatment patterns were observed in the real-world study?

Most patients had evidence of receiving at least 1 AR pathway inhibitor (97%) and/or 1 taxane (79%) prior to lutetium Lu 177 vipivotide tetraxetan. Additionally, 89% of patients initiated lutetium Lu 177 vipivotide tetraxetan in the fourth line of therapy or later following a diagnosis of mCRPC.

During treatment with lutetium Lu 177 vipivotide tetraxetan, 14% of patients had evidence of receiving another guideline-recommended therapy for mCRPC and 86% had no concomitant therapy. Patients who did receive a concomitant therapy received an AR pathway inhibitor (65%) or a PARP inhibitor (13%); the remaining patients received other therapies.

“Overall, these results suggest that patients receiving [lutetium Lu 177 vipivotide tetraxetan] after sipuleucel-T have a relatively slow disease course, with a median time from mCRPC onset of [more than] 3 years but still responded well to [lutetium Lu 177 vipivotide tetraxetan],” Shore and his coauthors wrote in their conclusion.

Disclosures: Shore has stock and other ownership interests in Photocure. He also holds consulting or advisory roles with Accord Research, Alessa Therapeutics, Amgen, Antev, Asieris Pharmaceuticals, Astellas Pharma, AstraZeneca, Aura Biosciences, Bayer, Bioprotect, Bristol-Myers Squibb/Sanofi, CG Oncology, Clarity Pharmaceuticals, Dendreon, Exact Imaging, Ferring, Fize Medical, Glytherix, ImmunityBio, InVitae, Janssen Scientific Affairs, Lantheus Medical Imaging, Lilly, MDxHealth, Medivation/Astellas, Merck, Minomic, Myriad Genetics, Novartis, Nusano, Pfizer, Photocure, PlatformQ Health, Promaxo, Protara Therapeutics, Sanofi, Siemens, Speciality Networks, Sumitomo Pharma Oncology, Telix Pharmaceuticals, Tolmar, Tutelix, and Urogen pharma. He has received research funding from AbbVie, Advantagene, Amgen, Aragon Pharmaceuticals, Astellas Pharma, AstraZeneca, Bayer, Boston Scientific, Bristol-Myers Squibb/Pfizer, CG Oncology, Clovis Oncology, Dendreon, DisperSol, Endocyte, Exact Imaging, Exelixis, Ferring, FKD Therapies, FORMA Therapeutics, Foundation Medicine, Genentech, Guardant Health, InVitae, Istari Oncology, Janssen, Jiangsu Yahong Meditech, MDxHealth, Medivation, Merck, MT Group, Myovant Sciences, Myriad Genetics, Novartis, Nymox, OncoCellMDx, ORIC Pharmaceuticals, pacific edge, Palette Life Sciences, Pfizer, Plexxikon, POINT Biopharma, Propella Therapeutics, Propella Therapeutics, RhoVac, Sanofi, SeaGen, Sesen Bio, Steba Biotech, Theralase, Tolmar, Urogen pharma, Urotronic, US Biotest, Vaxiion, Veru, and Zenflow.

References

  1. Shore ND, George DJ, Heath EI, et al. Outcomes of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) after sipuleucel-T in patients with metastatic castration-resistant prostate cancer (mCRPC): a real-world prostate cancer disease observation (PRECISION) data platform analysis. J Clin Oncol. 2026;44(suppl 7):88. doi:10.1200/JCO.2026.44.7_suppl.88
  2. FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. FDA. March 28, 2025. Accessed March 18, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication

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