Novartis: Positive phase 3 study with radioligand therapy in advanced prostate cancer

 Novartis today reported the first

interpretable results of the Phase III VISION study evaluating the 
efficacy and safety of (177) Lu-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(1) , 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(1) . 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(2) and need new treatment 
options. These groundbreaking data confirm our belief in the potential 
of (177) Lu-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 
(177) Lu-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. 

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