John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis explained, “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 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, 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.”
What is Radioligand Therapy?
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 treatment 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 pursuing four different cancer treatment platforms including:
- Radioligand therapy,
- Cell and Gene therapy,
- Targeted therapy and
With an opportunity to combine these platforms for the best outcomes for each cancer patient.
About Advanced Prostate Cancer
Prostate cancer 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 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 mCRPC. 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 mCRPC. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). 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.
For more information please visit the Novartis website.
This is, indeed, a great achievement by Novartis; saving the lives of the many patients suffering with mCRPC as no other, existing treatment can.
To read more about Novartis please click here.
Novartis Announced Positive Results of Phase 3 Study Using 177Lu-PSMA-617 in Advanced Prostate Cancer Patients
Novartis Positive Results for Radioligand Therapy, 177Lu-PSMA-617, for mCRPC
Novartis (NVS) reported the first interpretable results of 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 the best standard of care alone.
The good news is that the trial has met both primary endpoints of overall survival (OS) and radiographic progression-free survival (PFS). These results are expected to move 177Lu-PSMA-617 closer to becoming the targeted treatment for >80% of patients with advanced prostate cancer.
The safety profile was consistent with data reported in previous clinical studies.
The results from the VISION trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.