Novartis Seeks Label Expansion for Pluvicto Following Positive Phase III Results

Novartis is preparing to seek an expansion of its radioligand therapy Pluvicto's application, aiming to make it available to prostate cancer patients before they receive chemotherapy. This move comes in the wake of positive overall survival data from the Phase III PSMAfore study, which favored the treatment.

Although specific data were not disclosed, Novartis indicated an overall survival hazard ratio less than 1.0 for Pluvicto in the study's intent-to-treat group. The interim safety profile of Pluvicto was found to be in line with earlier findings, and full results will be presented at a future medical conference.

Pluvicto is an intravenously administered treatment designed to target the PSMA protein, commonly found on prostate cancer cells. The active component, lutetium-177, emits beta radiation that damages and destroys PSMA-positive cancer cells.

Initially approved by the FDA in March 2022 for adult patients with metastatic castration-resistant prostate cancer who test positive for the PSMA protein, Pluvicto is currently restricted to those who have had prior exposure to an androgen receptor pathway inhibitor and taxane-based chemotherapy.

Novartis is leveraging the PSMAfore study to advocate for Pluvicto's use in an earlier stage of treatment. Despite the trial's overall survival data being influenced by a significant cross-over effect, where 84% of patients shifted to Pluvicto after discontinuing ARPI treatment, the study still achieved its primary endpoint. It showed a 59% reduction in the risk of radiographic progression-free survival compared to switching to another ARPI therapy, along with improvements in quality of life and other benefits.

Should the label expansion be granted, Pluvicto could become an earlier treatment option for prostate cancer patients, potentially sparing them the harsh side effects of chemotherapy and expanding the market for this targeted therapy.