The Phase 3 trial has met the primary endpoint of radiographic progression-free survival (rPFS) in PSMA-positive mCRPC who have been treated with androgen-receptor pathway inhibitor (ARPI) therapy, compared to change in ARPI


Laboratory building (Virchow 6) on Novartis Campus. (Credit: Novartis AG)

Swiss drugmaker Novartis announced that the Phase 3 PSMAfore study of its targeted radiotherapy Pluvicto (lutetium vipivotide tetraxetan) has met its primary endpoint.

Pluvicto is an intravenous therapy that combines a ligand with a therapeutic radionuclide for the treatment of prostate-specific membrane antigen (PSMA).

The drug has been approved in the US and abroad to treat adults with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC), who are previously treated.

PSMAfore is a Phase 3, open-label, multi-centre, randomised study of Pluvicto in patients with PSMA-positive mCRPC, already treated with androgen-receptor pathway inhibitor (ARPI) therapy.

The Phase 3 study evaluated the efficacy and safety of Pluvicto in patients with PSMA-positive mCRPC, compared to change in ARPI therapy.

In the study, the drug showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), which is the primary endpoint.

Also, the treatment using Pluvicto did not cause any unexpected safety events, and the data is consistent with the already-well-established safety profile of the drug, said the Swiss firm.

Novartis global drug development president and chief medical officer Shreeram Aradhye said: “Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy.

“We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis.”

Pluvicto is a radioligand therapy that works by binding to the target cells, including prostate cancer cells that express PSMA, a transmembrane protein.

The energy emissions from the radioisotope will damage the target cells and other cells nearby, disrupting their ability to replicate or triggering cell death.

Pluvicto is already approved in the US and other countries, including the UK and Canada, and is recommended for approval in the European Union (EU).

The regulatory decisions are supported by the results from the Phase 3 VISION study.

In the Phase 3 VISION trial, patients with pre-treated PSMA–positive mCRPC were treated with Pluvicto plus standard of care, which showed a significant reduction in the risk of death.