Shares of Progenics Pharmaceuticals are up more than 20% in premarket trading after the company announced positive top-line results from its Phase III prostate cancer imaging tool PyL.
Shares of Progenics Pharmaceuticals are up more than 20% in premarket trading after the company announced positive top-line results from its Phase III prostate cancer imaging tool PyL. The late-stage data sets up plans to seek regulatory approval in 2020.
This morning, New York-based Progenics said its Phase III CONDOR trial hit the mark in men with biochemical recurrence of prostate cancer. The trial was assessing the diagnostic performance and clinical impact of PyL (F-DCFPyL), its PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer. It provides physicians with a visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. 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.
In the late-stage trial, patients were dosed and imaged with PyL. The trial achieved an 84.8% to 87% correct localization rate among three blinded readers. Correct localization rate (CRL) is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy, the company said in its announcement.
Safety results showed PyL was well tolerated and remained consistent with the Phase II OSPREY trial results. There was one serious adverse event of hypersensitivity reported in one patient as related to the study drug. The most frequent adverse event reported was headache, which was reported in four patients.
As a result of the positive trial outcomes, Progenics said it intends to seek approval for PyL from the U.S. Food and Drug Administration in the second half of 2020. Additional results from the CONDOR trial are expected to be presented at an upcoming medical meeting.
David Mims, interim chief executive officer of Progeny, said the positive results of the Phase III CONDOR trial reinforces the company’s belief in the potential of PyL as an option for physicians to make better treatment decisions and improve patient outcomes.
“The rapid trial enrollment and physician support further underscore the excitement and positive reception of PyL as a new addition in the fight against prostate cancer and, together with the commercial performance of diagnostic agents in use today, reinforce our belief in the significant market opportunity for PyL,” Mims said in a statement.
Barry Siegel, a professor of radiology at Washington University School of Medicine in St. Louis, said there is a need for improved diagnostics in prostate cancer to replace conventional imaging tests that have “limited performance characteristics, especially in men with biochemical recurrence of their disease.” Of the CONDOR study, Siegel said the “high positive predictive value” that was demonstrated by the data reflects the “clinical utility of PSMA-targeted PET imaging agents providing actionable information to physicians to guide treatment plans and improve disease management of one of the most prevalent cancers in the U.S.”
