NEW YORK – Novartis said on Tuesday that its investigational targeted radioligand therapy 177Lu-PSMA-617 has demonstrated a significant survival benefit as a treatment for prostate-specific membrane-antigen (PSMA)-positive, metastatic castration-resistant prostate cancer (mCRPC), and that the company plans to file for regulatory approval for the treatment in the US and EU this year.
In the Phase III VISION trial, 177Lu-PSMA-617 combined with the best available standard-of-care treatment improved both overall survival and radiographic progression-free survival versus standard-of-care treatments alone. The trial enrolled 831 patients with mCRPC whose cancers were determined to be PSMA-positive by PET imaging.
The investigational therapy, 177Lu-PSMA-617, is designed to deliver a radioisotope selectively to PSMA-expressing cancer cells by way of a bound ligand. PSMA was selected as a biomarker for the treatment because of its differential expression on prostate cancer cells relative to normal cells, and Novartis says that the radiation emitted from 177Lu-PSMA-617 has been shown to cause minimal damage to healthy surrounding tissue. The safety profile of the treatment in the VISION study was comparable to previously reported data.
Novartis said it plans to present the VISION trial data at an upcoming medical meeting.