Progenics to Present Results from the Phase 3 CONDOR Trial of PyL (18F-DCFPyL) in Prostate Cancer at the American Society of Clinical Oncology 2020 Virtual Scientific Program

- Met Primary Endpoint with a Correct Localization Rate of 84.8–87.0% -
- 63.9% Change in Disease Management Plan Based on PyL Imaging Results -
- Planned NDA Submission On Track for Early Third Quarter 2020 -

NEW YORK, May 18, 2020 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, today announced that the results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL^TM (¹⁸F-DCFPyL) in men with biochemical recurrence of prostate cancer will be presented in an oral session at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program. PyL is the Company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.

“The vast majority of men dying of prostate cancer, the second most common cause of cancer-related death in men, succumb to metastatic disease. Due to the limitations of conventional imaging, early detection and accurate localization of metastatic lesions in patients with biochemical recurrence of prostate cancer represents an important medical need,” said Peter R. Carroll, M.D., M.P.H., Distinguished Professor, Department of Urology, University of California, San Francisco. “New imaging agents, such as PyL, that enable early identification of metastatic disease, both at initial staging and at any point after definitive therapy, could have the potential to impact patient outcomes.” 

The Phase 3 CONDOR trial is a prospective, multi-center, open label pivotal trial in which 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities, including Axumin, Choline PET, CT/MR and/or bone scan, were dosed and imaged with PyL at 14 sites in the United States and Canada. The trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value (PPV), defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL and a composite truth standard comprised of histopathology, conventional imaging and/or a ≥ 50% decline in PSA levels following radiation therapy. Median CLR in patients with baseline PSA <0.5 ng/mL, 0.5 to <1.0 ng/mL, and 1.0 to <2.0 ng/mL were 73.3%, 75.0%, and 83.3%, respectively, which are promising results in a patient population  with non-informative baseline findings based on available approved imaging modalities.