Novartis prostate cancer treatment sees positive Phase III results

pharmafile | March 23, 2021 | News story | Manufacturing and Production |  Novartis, oncology 

Novartis has today announced positive results from its Phase III VISION study with 177Lu-PSMA-617, seeing significant improvements in overall survival (OS) and radiographic progression-free survival (rPFS) in patients with advanced prostate cancer.

The Phase III VISION study used 177Lu-PSMA-617, a targeted radioligand therapy, on patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The study was to test the safety and efficacy of the treatment, and found the safety profile was consistent with data reported in previous clinical trials.

The trial met both primary endpoints of overall survival and radiographic progression-free survival, helping 177Lu-PSMA-617 move closer to becoming the targeted treatment for around 80% of patients with advanced prostate cancer.

John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis, said: “Patients with mCRPC have a less than 1 in 6 chance of surviving 5 years and need new treatment options. These ground-breaking 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.

“We would like to thank the patients who volunteered to participate in this study as well as the clinical teams at each of the trial sites. We would not be able to realise our commitment to reimagining medicine without the partnership of patients and their families.”

Radioligand therapy combines a targeting compound that binds to markers expressed by tumours and a radioactive isotope, causing DNA damage that inhibits tumour growth and replication. This therapeutic approach enables targeted delivery of radiation to the tumour, while limiting damage to the surrounding normal tissue.

The VISION trial findings are to be presented in an upcoming medical meeting, with regulatory submissions in the EU and US expected this year.

Kat Jenkins