- 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.