Novartis PluvictoTM shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer - Seite 2

The vast majority of patients diagnosed with CRPC already present with metastases at time of diagnosis⁴, patients with metastatic prostate cancer have an approximate 3 in 10 chance of surviving 5 years⁵. Despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, and there is an urgent need for new targeted treatment options to help improve long-term outcomes^6,7,8,9.

Pluvicto is already approved for treatment in adult patients with PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy in the United States and several other countries^10-12.

About the PSMAfore Study
PSMAfore is a Phase III, open-label, multi-center, 1:1 randomized study comparing the efficacy and safety of Pluvicto to a change in ARPI in patients with PSMA–positive mCRPC¹³. Patients enrolled must have progressed only once after receiving a second-generation ARPI¹³. There were 469 participants enrolled in the study¹³. The primary endpoint is rPFS, defined as the time from randomization to radiographic progression by PCWG3-modified RECIST v1.1 (as assessed by blinded independent central review) or death¹³. Evaluation of overall survival, the key secondary endpoint, is ongoing as data remain immature.

About Pluvicto^TM (lutetium (¹⁷⁷Lu) vipivotide tetraxetan)
Pluvicto is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)³. After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein³. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death¹⁰.

Pluvicto is approved in the US and other countries to treat adults with a type of advanced cancer called PSMA–positive mCRPC and who have already been treated with other anticancer treatments (ARPI and taxane-based chemotherapy)^10-12. More specifically, in March 2022, the United States Food and Drug Administration (US FDA) approved Pluvicto¹⁰. In August and September 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada approved Pluvicto in Great Britain and Canada, respectively^11,12. In October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorization for Pluvicto¹⁴. These regulatory decisions are supported by the results from the pivotal Phase III VISION study, where patients with pre-treated PSMA–positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in the risk of death; both alternate primary endpoints of radiographic progression free survival and overall survival were met³.