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Novartis Reports Positive Data For Radioligand Therapy In Patients With Advanced Prostate Cancer

Novartis (NVS) announced positive health-related quality of life or HRQoL data from its Phase III VISION study evaluating 177Lu-PSMA-617, an investigational targeted radioligand therapy, plus standard of care for metastatic castration-resistant prostate cancer or mCRPC versus standard of care alone.

Many patients with mCRPC live with reduced physical functioning as well as significant pain.

The data from a quality of life assessment of the trial showed delayed worsening of these difficult to bear symptoms in the 177Lu-PSMA-617 plus standard of care arm compared to standard of care alone arm. No new or unexpected safety concerns, including changes in creatinine clearance, were noted, the company said in a statement.

The company will present the results at the European Society for Medical Oncology Congress, 17-21 September 2021.

The health-related quality of life analysis showed that the 177Lu-PSMA-617 plus standard of care arm resulted in an estimated 54% risk reduction in the worsening of HRQoL from baseline compared to the standard of care only arm.

In addition, 177Lu-PSMA-617 plus standard of care also resulted in an estimated 55% risk reduction of worsening of pain intensity from baseline compared to the standard of care only arm.

The company noted that two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting and in the metastatic hormone-sensitive setting.

Novartis said it is also evaluating opportunities to investigate 177Lu-PSMA-617 radioligand therapy in earlier stages of 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, the tumor shows signs of growth, such as rising Prostate Specific Antigen 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 metastatic prostate cancer is about 30%.

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