Results from Clinical Trial Show Progenics’ PyL (18F-DCFPyL) PSMA PET/CT Imaging Agent Changes Management Plans for More Than 87% of Patients

San Francisco, CA (UroToday.com) -- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, today announced that an analysis of an ongoing investigator-initiated study of PyLTM (18F-DCFPyL) in 130 men with biochemical recurrence of prostate cancer has been published in The Journal of Nuclear Medicine. PyL is Progenics’ PSMA-targeted small molecule PET/CT imaging agent designed to visualize prostate cancer. The publication is an analysis of an ongoing investigator-initiated prospective study of PyL, which is being conducted by the University of British Columbia and British Columbia Cancer Agency.

Physician post-scan assessments showed that a change in treatment intent (palliative intent to therapeutic intent or vice versa) occurred in 65.5% of patients.  Fifty percent of these patients were directed to palliative care from curative treatment and 50% of these patients were directed to curative treatment from palliative care. This change in treatment intent is a key measurement that demonstrates how increased access to disease visualization with PyL improves patient monitoring and care management. Post-scan physician assessments showed that imaging results upstaged or downstaged disease in 65.5% of patients, improved physician decision-making in 89.1% of patients, and changed management plans in 87.3% of patients.

Efficacy was measured in 130 patients who met the biochemical recurrence disease criteria and certain prostate-specific antigen (PSA) levels (reported in ng/mL). PyL detection rates of localized recurrent prostate cancer were 60% (patients with PSA of ≥0.4 to <0.5), 78% (patients with PSA of ≥0.5 to <1.0), 72% (patients with PSA of ≥1.0 to <2.0), and 92% (patients with PSA of ≥2.0). Safety data analyzed showed PyL was well tolerated with no serious adverse events and was considered safe.
“The data emerging from this ongoing study showed that the use of PyL improved decision making for referring oncologists with changed treatment intent for 65.5% of patients and changed disease management plans for 87.3% of patients in this large prospective cohort,” said Asha Das, M.D., Chief Medical Officer of Progenics.
“Due to the limitations in conventional imaging, there is an increased need for diagnostics to support the localization of disease recurrence and enable targeted treatment, which has the potential to improve patient outcomes and quality of life. The positive lesion detection and promising safety profile support continued research in PyL as an extremely valuable resource for physicians treating patients with biochemical recurrence of prostate cancer.”

Further Related Content: Journal of Nuclear Medicine: Official Publication
A Prospective Study on 18F-DCFPyL PSMA PET/CT Imaging in Biochemical Recurrence of Prostate Cancer.
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