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 - Seite 2

63.9% of patients in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The most frequent changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

“In addition to the robust diagnostic performance, the clinician’s high change in management rate based on PyL scans is a particularly significant finding of CONDOR. The subjects in this study represent a true clinical dilemma as there is residual disease present as demonstrated by the detectable PSA, but standard scans are uninformative. CONDOR demonstrates that clinicians trust the information on the PyL scan and use it,” said Michael J. Morris, M.D., Clinical Director, Genitourinary Medical Oncology Service & Prostate Cancer Section Head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the ASCO presentation. “These positive results further underscore the diagnostic potential for PSMA targeted imaging and open up future opportunities to examine how the results of PyL imaging can be used to deliver new, improved patterns of care.”

Consistent with the Phase 2 OSPREY trial results, safety results showed that PyL was well tolerated. There was one serious adverse event of hypersensitivity reported as related to the study drug in a patient with significant allergic history.

“The full positive results of our Phase 3 CONDOR trial continue to validate our beliefs in PyL to potentially alter the way physicians treat prostate cancer. The CONDOR results, together with previously presented data from OSPREY, collectively demonstrated strong diagnostic performance of PyL in multiple stages of the prostate cancer disease continuum,” said David Mims, Interim Chief Executive Officer of Progenics. “We remain on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL early in the third quarter of 2020.”

Details for the ASCO 2020 Virtual Scientific Program presentation are as follows:

Title: Impact of PSMA-targeted imaging with 18F-DCFPyL-PET/CT on clinical management of patients (pts) with biochemically recurrent (BCR) prostate cancer (PCa): Results from a phase III, prospective, multicenter study (CONDOR)
Presenter: Michael J. Morris, M.D., Clinical Director, Genitourinary Medical Oncology Service & Prostate Cancer Section Head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center