Drug Development and Manufacturing
Recently, researchers presented updated analysis results from the Phase 3 clinical trial PSMAfore of Novartis' radioligand therapy (RLT) Pluvicto (177Lu-PSMA-617) at the 2024 American Urological Association Annual Meeting (AUA 2024). The data showed,Pluvicto met the primary endpoint of the trial, more than doubling patients' radiographic progression-free survival (rPFS). Notably, the proportion of patients achieving complete response in the Pluvicto group was nearly 8 times that of the active control group.

The test results showed,Pluvicto reduced the risk of radiological disease progression by 57% (HR=0.43, 95% CI, 0.33-0.54) compared to switching ARPI medications. The median rPFS in the Pluvicto group was 12.02 months, compared to 5.59 months in the active control group.

Moreover, the objective response rate and complete response rate of Pluvicto were significantly higher than those of the active control group.The complete response rate in the Pluvicto group reached 21.1%, compared to only 2.7% in the control group.Pluvicto increased the complete response rate of patients nearly 8 times. Researchers stated,This positive outcome supports considering Pluvicto as the new standard therapy for treating this patient population.

Pluvicto is a radioligand therapy that links a small molecule compound targeting PSMA to a radioactive isotope.It can bind to prostate cancer cells expressing PSMA, and the radiation energy released by the radioactive isotope damages tumor cells, triggering cell death. Since the radiation emitted by Pluvicto only acts over a very short distance, it limits the drug's damage to surrounding healthy cells. Pluvicto was approved for marketing by the U.S. FDA in 2022 for the treatment of patients with PSMA-positive mCRPC who have already undergone taxane-based chemotherapy and androgen receptor signaling pathway inhibitor treatments.

▲Introduction to Pluvicto Therapy (Image Source: Novartis Official Website)
Radioligands are one of the key technology platforms being developed by Novartis. The company has recently been making frequent moves in this area, including spending more than$1.7 Billion AcquisitionMariana Oncology, a company dedicated to developing RLT. Novartis has also partnered with PeptiDreamExpand Polypeptide Discovery Collaboration, innovative macrocyclic peptides that can be used for conjugation with radioligands were discovered.

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