Data about overall survival seems immature to me, it seems like there is a slight advantage for the sequential therapy, not very significant, but both arms at 36 months are far away from having reached the median. So I think we have to wait for that parameter.
The study enrolled 130 patients with de novo high-volume mHSPC who had initiated androgen deprivation therapy (ADT) within four weeks and had a PSA level greater than 10 ng/ml at diagnosis. Patients underwent PSMA and FDG PET scans to confirm high PSMA uptake and were randomized into two groups:
Experimental Arm: Two cycles of 177Lu-PSMA-617 followed by six cycles of docetaxel.
Control Arm: Six cycles of docetaxel alone.
The primary endpoint was achieving an undetectable PSA level (≤0.2 ng/ml) at 48 weeks. Results showed that 41% of patients in the experimental arm reached this endpoint, compared to 16% in the control arm (odds ratio [OR]: 3.88; p=0.002).
Additionally, the experimental arm demonstrated:
Improved PSA Progression-Free Survival: Median of 31 months versus 20 months (hazard ratio [HR]: 0.60; p=0.039).
Delayed Development of Castration Resistance: HR of 0.60 (p=0.033).