Dr Dorff on the Safety of Lutetium Lu 177 Vipivotide Tetraxetan in mCRPC With Renal Impairment

“Essentially, the results were negative. There was no difference [in safety compared with patients without impaired renal function], so that's very reassuring. The VISION trial enrolled patients with an eGFR of 50 mL/min or higher, and we had some patients with eGFRs in the 30s and 40s.”

Tanya B. Dorff, MD, section chief of the Genitourinary Disease Program and professor in the Department of Medical Oncology and Therapeutics Research at City of Hope, highlighted the safety profile of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in patients with metastatic castration-resistant prostate cancer (mCRPC) with impaired renal function.

Findings from a retrospective analysis, which were presented at the 2025 Genitourinary Cancers Symposium, demonstrated that patients treated with lutetium Lu 177 vipivotide tetraxetan had an estimated glomerular filtration rate (eGFR) of less than 60 mL/min did not identify an increased incidence of adverse effects (AEs), which included anemia.

The results did not differ from safety outcomes for patients with mCRPC who did not have renal function impairment, which was a positive finding, Dorff began. The phase 3 VISION trial (NCT03511664) included patients with an eGFR of 50 mL/min or greater, whereas the retrospective analysis evaluated patients whose eGFRs were less than 60 mL/min, she explained. However, she noted that the analysis provided a small sample size, and more data are needed, which suggested that an extended application of the VISION trial regimen could benefit a larger patient population.

Looking ahead, Dorff added that it would be of interest to include a larger and more diverse patient population. She explained that other City of Hope centers in the United States, including Georgia, Arizona, and Illinois, could help provide a more geographically diverse outcomes when those data are included. Assessing these broader data may also open the door for additional questions and help identify whether the results will change because of a larger and more geographically diverse patient population treated with lutetium Lu 177 vipivotide tetraxetan, Dorff concluded.