Novartis announces Phase III PSMAddition trial met primary endpoint

Novartis (NVS) announced topline results from a pre-specified interim analysis of the Phase III PSMAddition trial. The trial met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival with a positive trend in overall survival, OS, in patients with prostate-specific membrane antigen-positive metastatic hormone-sensitive prostate cancer, mHSPC, treated with radioligand therapy, Pluvicto, in combination with standard of care versus SoC alone1. In PSMAddition, the SoC is a combination of androgen receptor pathway inhibitor therapy and androgen deprivation therapy. Almost all mHSPC patients ultimately progress to metastatic castration-resistant prostate cancer. There is a need for additional treatment options with novel mechanisms of action that further delay progression, prolong OS and improve disease control compared to the current SoC, while showing a favorable safety and tolerability profile.