Racial Differences Do Not Affect PSA Response With Lutetium Lu-177 Vipivotide Tetraxetan in mCRPC

Treatment with lutetium Lu-177 vipivotide tetraxetan (Pluvicto) did not lead to a difference in prostate-specific antigen (PSA) response among Black patients with metastatic castration-resistant prostate cancer (mCRPC) compared with White patients, according to data from a retrospective cohort study presented during the 2026 Genitourinary Cancers Symposium.¹

Findings demonstrated that Black patients who received lutetium Lu-177 vipivotide tetraxetan (n = 27) experienced a 50% or more decline in PSA levels from baseline (PSA50) at a rate of 47.8% compared with 35.5% among White patients (n = 35; P = .03614). Patients with tumors harboring homologous recombination repair (HRR) mutations (n = 9) experienced a PSA50 response of 33.3% compared with 42.5% among those who did not have HRR mutations (n = 40; P = .7199). Those who received prior docetaxel (n = 47) had a PSA50 response of 40.4% compared with 50.0% among those who did not (n = 8; P = .7071).

“Although a substantial proportion of our cohort identified as Black or African American there was no significant difference in PSA response to [lutetium Lu-177 vipivotide tetraxetan] compared with White patients,” Ramyashree Nyalakonda, DO, an internal medicine resident in the Department of Hematology/Oncology at the Ochsner Clinic Foundation in New Orleans, Louisiana, and her coauthors wrote in a poster presentation of the data. “Patients with HRR mutations and prior docetaxel therapy had [a] numerically lower PSA50 response rate, but no statistically significant difference was found.”

In March 2025, the FDA expanded the indication of lutetium Lu 177 vipivotide tetraxetan to include adult patients with prostate-specific membrane antigen (PSMA)–positive mCRPC who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.² The expansion followed the March 2022 FDA approval of the agent for the treatment of adult patients with PSMA-positive mCRPC who have previously received other anticancer therapies, such as an APRI and taxane-based chemotherapy.³

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

1. 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
2. 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
3. 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