Novartis posts phase 3 data for 177Lu-PSMA-617 in hormone-sensitive prostate cancer

Novartis Pharmaceuticals posted phase 3 results for 177Lu-PSMA-617 plus standard of care in metastatic hormone-sensitive prostate cancer on ClinicalTrials.gov on Wednesday. The open-label, randomized trial, NCT04720157, compared the radiopharmaceutical plus androgen receptor-directed therapy and androgen deprivation therapy with standard of care alone, and its primary endpoint was radiographic progression-free survival.

The registry entry reports a p value of 0.002 for the primary endpoint but lists median radiographic progression-free survival as “NA” for both the 177Lu-PSMA-617 plus standard-of-care arm and the standard-of-care-alone arm. The results page provides no absolute medians, hazard ratio, or other effect-size measure, so the magnitude of any difference cannot be assessed from this posting.

The trial enrolled adult male patients with metastatic hormone-sensitive prostate cancer. Standard of care was defined as androgen receptor-directed therapy plus androgen deprivation therapy. Investigators planned to randomize approximately 1126 participants; as of 31 January 2024, 1144 participants had been enrolled in 19 countries. The study status is listed as active but not recruiting.

The registry describes radiographic progression-free survival as time from randomization to radiographic progression or death from any cause, assessed up to approximately 43 months. Because these data appear only as a ClinicalTrials.gov posting, they have not been independently peer reviewed.