Data from a Prospectively Designed Independent Trial of 130 Patients showed that PyL upstaged and downstaged disease in 65.5% of patients

 Progenics Pharmaceuticals, Inc. (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 PyL^TM (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.”

About PyL™ for PET Imaging of Prostate Cancer

PyL (also known as ¹⁸F-DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography (“PET”) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.  Progenics initiated patient dosing of a Phase 3 study evaluating the diagnostic performance and clinical impact of PyL in November 2018. The Phase 3 CONDOR trial is a multi-center, open label trial that will enroll approximately 200 male patients with biochemical recurrence of prostate cancer in 14 sites in the United States and Canada. The Company expects to complete enrollment in the fourth quarter of 2019 and report data in early 2020.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

About PROGENICS

Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA^®, 1095, and PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted imaging agent for prostate cancer (PyL™); and imaging analysis technology (aBSI and PSMA AI). Progenics has two commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and RELISTOR^® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies Inc.