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2022-12-07| Trials & Approvals

Novartis’ Pluvicto Continues Winning Streak In Prostate Cancer Indication

by Joy Lin
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Novartis’ Pluvicto, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy has achieved its primary endpoint in a Phase 3 study in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have received androgen-receptor pathway inhibitor (ARPI) therapy. 

In the Phase 3 study called PSMAfore, Pluvicto showed statistically significant and clinically meaningful radiographic progression-free survival (rPFS) in PSMA mCRPC patients, making it the first PSMA-targeted radioligand therapy to show clinical benefit in mCRPC patients before receiving taxable-based chemotherapy. Evaluation for overall survival, a key secondary endpoint in PSMAfore, is ongoing as the data remain immature, said Novartis.  

Bolstered by the good news, Novartis will present the findings at an upcoming medical meeting with the US FDA and file for approval for Pluvicto in 2023. 

Related Article: Janssen Drops Out of Prostate Cancer Clinical Trial Due to Lack of Patients

Radioligand Therapy For Prostate Cancer

Pluvicto, previously known as 177Lu-PSMA-617, is an intravenous radioligand therapy that is composed of a seeking compound and a lutetium-177 radioisotope. The compound binds to markers expressed by the tumor to specifically deliver the DNA-damaging radioactive payload. The targeted delivery comes with the benefit of limiting damage to surrounding healthy cells. 

Pluvicto’s latest success is its second, coming a year after the Vision study that evaluated Pluvicto for patients with PSMA-positive mCRPC who had been treated with ARPI and taxane-based chemotherapy. In Vision, patients who received Pluvicto experienced a statistically significant reduction in risk of death. 

The positive topline from Vision served as the basis for Pluvicto’s FDA approval this March. The drug has since been approved in Canada, while in October Europe’s Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the drug for marketing approval. 

No unexpected safety signals were found in PSMAfore, while the data are consistent with the safety profile of Pluvicto in previous studies, said Novartis. 

The company is also evaluating Pluvicto in earlier stages of prostate cancer, which could boost sales of the drug. Since its launch, Pluvicto has surpassed analyst expectations with sales of $80 million in the third quarter of 2022, according to Novartis’ latest financial report

Pluvicto was originally developed by Endocyte before its 2018 acquisition by Novartis for $2.1 billion. 

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