Pluvicto™ offers survival benefits for metastatic prostate cancer
Posted: 5 December 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The PSMA-targeted radioligand is first to significantly improve radiographic progression-free survival for PSMA–positive metastatic castration-resistant prostate cancer, shows study.
Novartis has announced its Phase III PSMAfore study with Pluvicto™, lutetium (177Lu) vipivotide tetraxetan, demonstrated improved radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) after androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI.
“With the announcement of these positive topline Phase III results, 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,” declared Dr Shreeram Aradhye, President, Global Drug Development and Chief Medical Officer at Novartis.
The PSMAfore study
PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto™ to a change in ARPI in 469 patients with PSMA–positive mCRPC. No unexpected safety findings were observed in PSMAfore. The data is consistent with the safety profile of Pluvicto™. The key secondary endpoint, evaluation of overall survival, is ongoing.
The PSMAfore results are the second positive set of data for Pluvicto™ in a Phase III trial, after the VISION clinical trial, where PSMA–positive mCRPC patients who received Pluvicto™ plus standard of care (SoC) after ARPI and taxane-based chemotherapy, showed statistically significant reduction in risk of death.
Pluvicto™ is already approved for treatment in adults with PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy including the US and UK. Novartis is evaluating opportunities to investigate Pluvicto™ in earlier stages of prostate cancer.
Pluvicto™ for PSMA–positive metastatic castration-resistant prostate cancer
Pluvicto™ is an intravenous radioligand therapy that combines a ligand, a targeting compound with lutetium-177, a therapeutic radionuclide. After entering the bloodstream, Pluvicto™ binds to target cells, including PSMA-expressing prostate cancer cells, a transmembrane protein. After binding to the cells, the radioisotope damages the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.
The Phase III data will be presented at an upcoming medical meeting. Regulatory approval will be discussed with the US Food and Drug Administration (FDA) in 2023.