Lu-177 prostate-specific membrane antigen-617 (Lu-177 PSMA-617, Pluvicto) may be safely delivered in patients with impaired renal function, according to research presented February 13 at a symposium in San Francisco.
The finding provides new evidence on the safety of Pluvicto in prostate cancer patients outside what was learned in the main trials leading to U.S. approval of the drug, noted Allen Seylani, of the City of Hope in Riverside, CA, and colleagues, who presented a poster on the topic at the American Society of Clinical Oncology's 2025 Genitourinary Cancers Symposium.
“Not much is known regarding the safety of dosing of Lu-177 in patients with creatinine clearance outside the range included in the VISION trial, which was ≤ 50 mL/min,” the group wrote.
Lu-177 PSMA-617 was approved in 2022 for adult patients with metastatic castration-resistant prostate cancer who have previously received other anticancer therapies, based largely on the VISION trial, which was conducted from June 2018 to October 2019. To provide real-world evidence on its safety, in this study, the researchers analyzed whether there were increased cases of adverse events in patients with impaired renal function who received standard doses of the drug.
The researchers analyzed data on 58 patients between the ages of 40 and 86 who received treatment between 2022 and 2024 at the City of Hope Comprehensive Cancer Center. Impaired renal function was defined as an estimated glomerular filtration rate (eGFR) test ≤ 60. prior to initiation of therapy. eGFR is a test that measures how kidneys filter waste from the blood, with results below 60 mL/min indicating chronic kidney disease.
Among the group, there were six patients with low eGFR (37 to 60 mL/min) and 36 patients with normal eGFR above 60 mL/min. In terms of adverse events, the most common were anemia (41.5%), thrombocytopenia (12.3%), xerostomia (10.7%), and fatigue (10.7%).
According to a Fisher’s exact test, there was no significant difference noted in incidence of all adverse events, incidence of anemia, or incidences of grade 3 or 4 anemia between those with impaired renal function (p = 0.7119) and those with normal function (p = 0.6649), the researchers reported.
Ultimately, compared with adverse event profiles described in prior research, patients with impaired kidneys experience a similar profile, the group noted.
“Lu-177 (Pluvicto) may be safely dosed in patients with impaired renal function, eGFR <60 mL/min, without significantly increasing the risk of [adverse events] including anemia, thrombocytopenia, and xerostomia,” the researchers concluded.
