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March 30, 2021

LoA Update: Novartis’ Lu-PSMA FDA approval shot in castration-resistant prostate cancer increases 8 points after Phase III efficacy signal

Novartis’ 177Lu-PSMA-617 (Lu-PSMA) for metastatic castration-resistant prostate cancer patients had its likelihood of approval (LoA) rising by 8 points as of 25 March.

By Reynald Castañeda

Novartis’ 177Lu-PSMA-617 (Lu-PSMA) for metastatic castration-resistant prostate cancer patients had its likelihood of approval (LoA) rising by 8 points as of 25 March. The increase was due to an announcement on 23 March that the Phase III VISION trial which investigated the targeted radioligand therapy met its coprimary endpoints.

Lu-PSMA previously had an LoA of 23%, according to GlobalData analysis that uses a combination of machine learning and a proprietary algorithm. Lu-PSMA targets prostate-specific membrane antigen (PSMA) in prostate cancer, and the linked therapeutic radioisotope damages tumour cells. VISION recruited progressive PSMA-positive patients and compared Lu-PSMA with best standard of care alone. While a company media release shows trial coprimary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) were met, details will be made public in an undisclosed medical meeting. The company plans to submit regulatory filings for the therapy in the US and EU this year.

On August 2019, this news service reported VISION’s rPFS coprimary endpoint drew mixed investigator response about its clinical significance in castration-resistant prostate cancer. rPFS allows for a quicker measure of a therapy’s potential efficacy versus the OS coprimary endpoint, and that OS is influenced by nontreatment-related deaths. However, OS is still the most objective way to measure treatment progress, and rPFS does not predict a therapy’s potential for OS. 177Lu-PSMA-617 was initially developed at Endocyte, which was acquired by Novartis in December 2018 for $2.1bn.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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