[177Lu]Lu-PSMA-617 Plus Standard of Care Versus Standard of Care Alone for Patients With mCRPC

By Emily Menendez - Last Updated: July 5, 2023

The phase 3 VISION trial utilized the prostate-specific membrane antigen (PSMA) radioligand therapy [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) plus protocol-permitted standard of care in patients with metastatic castration-resistant prostate cancer (mCRPC) to determine the combination’s efficacy in improving radiographic progression-free survival and overall survival.

A new analysis of the VISION trial, led by Karim Fizazi, MD, PhD, revealed additional outcomes related to health-related quality of life (HRQOL), pain, and symptomatic skeletal events.

The VISION trial included 831 patients who were enrolled between June 2018 and October 2019. Eligible patients were 18 years of age or older with progressive PSMA-positive mCRPC and an Eastern Cooperative Oncology Group performance status score of 0 to 2. Patients also must have received at least 1 androgen receptor pathway inhibitor and 1 or 2 taxane-containing regimens.

Patients were randomly assigned 2:1 to receive either [177Lu]Lu-PSMA-617 plus standard of care ([177Lu]Lu-PSMA-617 group) or standard of care alone (control group). A total of 581 patients were eligible for the trial and randomly assigned to each group for analysis of HRQOL, pain, and time to first symptomatic skeletal event.

The median time to first symptomatic skeletal event or death was 11.5 months (95% CI, 10.3-13.2) in the [177Lu]Lu-PSMA-617 group and 6.8 months (range, 5.2-8.5 months) in the control group (hazard ratio, 0.50; 95% CI, 0.40-0.62). Time to worsening in HRQOL was delayed in the [177Lu]Lu-PSMA-617 group over the control group. Grade 3 or 4 adverse events (AEs) included decreased hemoglobin, lymphocyte concentrations, and platelet counts. Treatment-related AEs leading to death occurred in 5 (1%) patients who received [177Lu]Lu-PSMA-617 plus standard of care and in no patients who received standard of care alone.

[177Lu]Lu-PSMA-617 plus standard of care was found to delay time to worsening in HRQOL and time to skeletal events compared with standard of care alone. The use of [177Lu]Lu-PSMA-617 in patients with mCRPC who received prior androgen receptor pathway inhibitor and taxane treatment is promising.