By VETTAPHARMA reporter – Derek Roche: Novartis presented new data from the PSMAddition Phase III trial, showing that Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) reduced the risk of prostate-specific antigen (PSA) progression by 58% in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The PSMAaddition trial evaluated Pluvicto in combination with standard-of-care androgen receptor pathway inhibitor (ARPI) therapy, with the study designed to assess whether earlier use of radioligand therapy could improve outcomes in patients with advanced prostate cancer.
Additional findings showed improved PSA response depth and delayed disease progression, supporting the potential expansion of Pluvicto beyond its current use in metastatic castration-resistant prostate cancer (mCRPC).
Pluvicto is a targeted radioligand therapy that binds to prostate-specific membrane antigen (PSMA)-positive cells, delivering radioactive treatment directly to tumor sites while limiting exposure to surrounding healthy tissue.
The latest PSMAaddition data aligns with Novartis’ strategy of expanding its radioligand therapy platform into earlier treatment settings, while strengthening its oncology portfolio through precision medicine approaches.
For patients with metastatic hormone-sensitive prostate cancer, earlier integration of radioligand therapy could potentially provide better disease control and delayed progression, particularly in patients with PSMA-positive disease.
From a commercial perspective, positive Phase III data in mHSPC may significantly expand the eligible patient population for Pluvicto, supporting future growth in Novartis’ radioligand therapy franchise as additional regulatory and label expansion opportunities emerge.

