- New quality of life data for 177Lu-PSMA-617 plus standard of care shows delay in worsening of health-related quality of life (HRQoL) and pain in heavily pre-treated patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to standard of care alone1
- US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to 177Lu-PSMA-617; Submission to FDA and European Medicines Agency on track for 2H21
- Novartis committed to reimagining prostate cancer with targeted radioligand therapy; two Phase III studies with 177Lu-PSMA-617 in earlier lines of treatment ongoing with goal to investigate earlier stages of disease
San Francisco, CA (UroToday.com) -- Novartis announced positive health-related quality of life (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 (mCRPC) versus standard of care alone. Many patients with mCRPC live with reduced physical functioning as well as significant pain.2,3 This data from a quality of life assessment of the VISION trial, referred to as HRQoL, 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.1 These results will be presented at the European Society for Medical Oncology (ESMO) Congress, 17-21 September 2021.
HRQoL ad hoc analysis showed that the 177Lu-PSMA-617 plus standard of care arm resulted in an estimated 54% risk reduction in the worsening of HRQoL (measured by Functional Assessment of Cancer Therapy – Prostate (FACT-P) scale) from baseline (hazard ratio: 0.46 with 95% confidence interval (CI): (0.35, 0.61)) compared to the standard of care only arm.1 In addition, 177Lu-PSMA-617 plus standard of care also resulted in an estimated 55% risk reduction of worsening of pain intensity (measured by Brief Pain Inventory – Short Form (BPI-SF) scale) from baseline (hazard ratio: 0.45 with 95% (CI): (0.33, 0.60)) compared to the standard of care only arm.1
“Patients with mCRPC suffer from many complications associated with advanced disease that can impact their quality of life,"2,3 said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. “These new data emphasize the potential impact on quality of life that investigational 177Lu-PSMA-617 may provide as a potential new treatment option, beyond previously reported improvements in overall survival and radiographic progression-free survival."4Two 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 (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition). Novartis is also evaluating opportunities to investigate 177Lu-PSMA-617 radioligand therapy in earlier stages of prostate cancer.
Source: "Novartis Reports Positive Health-Related Quality Of Life Data For 177Lu-PSMA-617 Radioligand Therapy In Patients With Advanced Prostate Cancer At ESMO 2021 | Novartis". 2021. Novartis.