VISION study with 177Lu-PSMA-617 has met both primary endpoints, significantly improving overall survival and radiographic progression-free survival in patients with PSMA-positive metastatic castration-resistant prostate cancer
The first interpretable results of the phase III VISION study evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer ( mCRPC ) compared to best standard of care alone, were reported.
The trial met both primary endpoints of overall survival and radiographic progression-free survival.
The safety profile was consistent with data reported in previous clinical studies.
Radioligand therapy combines a targeting compound that binds to markers expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication.
This therapeutic approach enables targeted delivery of radiation to the tumor, while limiting damage to the surrounding normal tissue.
More than 80% of prostate cancer tumors highly express a phenotypic biomarker called Prostate Specific Membrane Antigen ( PSMA ), making it a promising diagnostic ( through positron emission tomography [ PET ] scan imaging ) and therapeutic target for radioligand therapy.
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer.
After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA, a transmembrane protein, with high tumor-to-normal tissue uptake. Once bound, emissions from the radioisotope damage tumor cells, disrupting their ability to replicate and/or triggering cell death.
The radiation from the radioisotope works over very short distances to limit damage to surrounding cells.
VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of 177Lu-PSMA-617 ( 7.4 GBq administered by i.v. infusion every 6 weeks for a maximum of 6 cycles ) plus investigator-chosen best standard of care in the investigational arm, versus best standard of care in the control arm.
Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor-directed therapy ( ARDT ), were randomized in a 2:1 ratio in favor of the investigational arm.
The alternate primary endpoints were radiographic progression-free survival ( rPFS ) and overall survival ( OS ).
The study enrolled 831 patients. ( Xagena )
Source: Novartis, 2021