Results from the phase 3 PSMAddition trial showed that adding lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to androgen-deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) improved prostate-specific antigen (PSA) responses in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The randomized phase 3 study included 1,144 men with PSMA-positive mHSPC. Patients received either Pluvicto plus ADT and ARPI or standard ADT and ARPI alone. Median follow-up was 23.6 months.
The addition of Pluvicto reduced the risk of PSA progression by 58% compared with standard therapy alone. PSA progression occurred in 8.7% of patients in the radioligand arm versus 18.7% in the control arm.
Patients receiving Pluvicto also achieved deeper PSA declines. At week 48, 87.4% of patients in the combination arm reached PSA levels below 0.2 ng/mL compared with 74.9% in the control arm. PSA levels below 0.02 ng/mL were achieved in 65.3% versus 46.7% of patients, respectively.
Researchers said the findings further support the clinical benefit of Pluvicto in first-line mHSPC, building on previously reported improvements in radiographic progression-free survival.