March, 23, 2021: “Novartis reported 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.
The trial met both primary endpoints of overall survival and radiographic progression-free survival, helping to move closer the ambition of becoming the targeted treatment for >80% of patients with advanced prostate cancer.
The safety profile was consistent with data reported in previous clinical studies.
Results from the VISION trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.
“Patients with metastatic castration-resistant prostate cancer have a less than 1 in 6 chance of surviving 5 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,” said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis.
“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 realize 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 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.
Novartis has established global expertise and specialized supply chain and manufacturing capabilities across its network of four radioligand therapy production sites, and is further increasing capacity to ensure delivery of radioligand therapies like 177Lu-PSMA-617 to patients in need.
Novartis is the only pharmaceutical company which is pursuing four different cancer treatment platforms.
These include radioligand therapy, cell and gene therapy, and targeted therapy and immunotherapy, with an opportunity to combine these platforms for the best outcomes for each cancer patient.
About Advanced Prostate Cancer
Prostate cancer is a form of cancer that develops in the prostate gland, a small walnut shaped gland in the pelvis of men.
In castration resistant prostate cancer (CRPC), the tumor shows signs of growth, such as rising Prostate Specific Antigen (PSA) levels, despite the use of hormone treatments that lower testosterone..
In metastatic CRPC (mCRPC), the tumor spreads to other parts of the body, such as neighboring organs or bones and remains unresponsive to hormone treatment.
The five-year survival rate for patients with mCRPC is approximately 15%.
About Phenotypic Precision Medicine in Advanced Prostate Cancer
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with metastatic castration resistant prostate cancer.
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.”
