Novartis has reported the first interpretable, positive results from the Phase III VISION study of investigational PSMA-targeted radioligand therapy, 177Lu-PSMA-617, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
177Lu-PSMA-617 is a kind of precision cancer therapy merging a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle).
When administered into the bloodstream, 177Lu-PSMA-617 attaches to prostate cancer cells that express PSMA. On binding, emissions from the radioisotope damage tumour cells disrupting their ability to replicate and/or trigger cell death.
The international, prospective, randomised, open-label, multi-centre study evaluated the efficacy and safety of 177Lu-PSMA-617.
The study had 831 subjects with PSMA PET-scan positive mCRPC and progression after prior taxane and androgen receptor-directed therapy (ARDT). The patients were randomised in a 2:1 ratio in favour of the investigational arm.
They received 7.4 GBq 177Lu-PSMA-617 administered intravenously every six weeks for a maximum of six cycles, along with the investigator-chosen best standard of care (in the investigational arm) or best standard of care (in the control arm).
Data showed that the trial met both primary endpoints, significantly improving overall survival (OS) and radiographic progression-free survival (rPFS) in PSMA-positive mCRPC patients.
Novartis noted that the latest development aids in nearing the goal of 177Lu-PSMA-617 becoming the targeted treatment for over 80% of advanced prostate cancer patients.
Furthermore, the safety profile was consistent with previously reported results from prior clinical studies.
Novartis Global Drug Development head and chief medical officer John Tsai said: “Patients with metastatic castration-resistant prostate cancer have a less than one in six chance of surviving five years and need new treatment options.
“These groundbreaking data confirm our belief in the potential of 177Lu-PSMA-617 to reimagine outcomes for these patients through phenotypic precision medicine. We intend to submit these data to regulatory authorities as soon as possible.”