Key Takeaways From the Retrospective Analysis
- PSA50 outcomes with lutetium Lu-177 vipivotide tetraxetan did not differ by race in patients with mCRPC.
- Patients with disease harboring HRR mutations (n = 9) experienced a PSA50 rate of 33.3% compared with 42.5% among those who did not have HRR mutations (n = 40; P = .7199).
- The collection of data for survival and safety end points is ongoing.
How was the retrospective study designed?
The study authors conducted a retrospective, institutional review board–approved cohort study of patients treated with lutetium Lu 177 vipivotide tetraxetan at Ochsner Medical Center.1 The study included patients treated after October 10, 2023, with a follow-up duration of up to 1 year. It was design to evaluate the real-world effectiveness and safety outcomes of patients treated with lutetium Lu 177 vipivotide tetraxetan, with a focus on potential racial differences.
Demographic, clinical, and treatment data were gathered from institutional databases, including efficacy and safety outcomes. Patient characteristics were summarized via descriptive statistics. Group comparisons were performed using chi-square or Fisher’s exact tests and relative risk estimates were calculated in order to evaluate associations between clinical characteristics and outcomes.
At baseline, most patients were White (57.4%), had HRR-mutated disease (81.6%), and received prior treatment with docetaxel (85.5%). Of note, racial data were missing for 1 patient, and HRR data were missing for 6 patients.
What were the safety data from the retrospective study?
In terms of safety, patients treated with lutetium Lu 177 vipivotide tetraxetan (n = 55) experienced dry mouth (n = 19), required transfusions (n = 4), and were hospitalized (n = 20). Throughout treatment, hemoglobin levels fell from 11.1 g/dL at baseline to 9.6 g/dL; platelet counts fell from 248 to 152; white blood cell counts fell from 6.8 to 4.4; creatinine levels rose slightly from 1.2 to 1.3; and glomerular filtration rate fell from 56.5 to 53.
“These findings underscore the need for continued research into how patient characteristics and prior treatments influence outcomes with [lutetium Lu 177 vipivotide tetraxetan] in advanced prostate cancer. Collection of survival and safety end points is ongoing,” Nyalakonda and her coauthors wrote in conclusion.
Disclosures: Dr Nyalakonda had no relevant financial relationships to disclose.
References
- Nyalakonda R, Halbert B, Arcot, et al. Impact of lutetium Lu 177 vipivotide tetraxetan on prostate cancer outcomes by race. J Clin Oncol. 2026;44(suppl 7):155. doi:10.1200/JCO.2026.44.7_suppl.155
- FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. FDA. March 28, 2025. Accessed March 12, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
- FDA approves Pluvicto for metastatic castration-resistant prostate cancer. News release. FDA. March 23, 2022. Accessed March 12, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer?utm_medium=email&utm_source=govdelivery