Progenics Pharmaceuticals Announces Phase 3 CONDOR Trial of PyL™ in Prostate Cancer Achieved Primary Endpoint
23 Dicembre 2019 - 1:00PM
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company
developing innovative targeted medicines and artificial
intelligence to find, fight and follow cancer, today announced
positive top line results from the Phase 3 CONDOR trial evaluating
the diagnostic performance and clinical impact of
PyL™ (18F-DCFPyL) in men with biochemical recurrence of
prostate cancer. PyL is the Company’s PSMA-targeted small molecule
positron emission tomography (PET) imaging agent designed to
visualize prostate cancer.
“There is a need for improved diagnostics for
prostate cancer to replace conventional imaging tests that have
limited performance characteristics, especially in men with
biochemical recurrence of their disease,” said Barry Siegel, MD,
Professor of Radiology at Washington University School of Medicine
in St. Louis. “The high positive predictive value demonstrated in
this study 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.”
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 (i.e. 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 CONDOR 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, defined as
the percentage of patients with a one-to-one correspondence between
localization of at least one lesion identified on 18F-DCFPyL PET/CT
and a composite truth standard comprised of histopathology,
conventional imaging and/or changes in PSA levels following
radiation therapy.
Safety results showed PyL was well tolerated,
consistent with the Phase 2 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 (1.9% of
the trial population).
“The positive results of our Phase 3 CONDOR
trial reinforce our belief in the potential of PyL to enable better
physician treatment decisions and, ultimately, 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,” said David Mims, Interim CEO. “Based on these positive
results, we plan to submit a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for PyL in the second half of
2020.”
Additional results from the CONDOR trial are
expected to be presented at an upcoming medical meeting.
Investor Conference CallProgenics
will host a conference call today at 8:00 AM Eastern Time to
discuss the results. The live and replayed webcast of the call will
be available through the Company's website at www.progenics.com. To
participate in the live call by phone, dial (877) 250-8889 (USA) or
(720) 545-0001 (international) and enter the passcode 9165086. The
replay of the call will be available for 90 days.
About PyL™ for PET Imaging of Prostate
CancerPyL (also known as 18F-DCFPyL) is a fluorinated
PSMA-targeted positron emission tomography (“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.
About Prostate CancerProstate
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 agents for prostate cancer (PyL™ and 1404); and
imaging analysis technology (aBSI and PSMA AI). Progenics has three
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 oral and subcutaneous
formulations of RELISTOR® (methylnaltrexone bromide) for the
treatment of opioid-induced constipation, which are partnered with
Bausch Health Companies Inc.
Forward Looking StatementsThis
press release contains projections and other “forward-looking
statements” regarding future events. Statements contained in this
communication that refer to Progenics’ estimated or anticipated
future results or other non-historical facts are forward-looking
statements that reflect Progenics’ current perspective of existing
trends and information as of the date of this communication and
include statements regarding Progenics’ strategic and operational
plans and delivering value for shareholders. Forward looking
statements generally will be accompanied by words such as
“anticipate,” “believe,” “plan,” “could,” “should,” “estimate,”
“expect,” “forecast,” “outlook,” “guidance,” “intend,” “may,”
“might,” “will,” “possible,” “potential,” “predict,” “project,” or
other similar words, phrases or expressions. Such statements are
predictions only and are subject to risks and uncertainties that
could cause actual events or results to differ materially. These
risks and uncertainties include, among others: risks associated
with the proposed merger transaction with Lantheus Holdings, Inc.;
market acceptance for approved products; the risk that the
commercial launch of AZEDRA may not meet revenue and income
expectations; the cost, timing and unpredictability of results of
clinical trials and other development activities and
collaborations; the unpredictability of the duration and results of
regulatory review of New Drug Applications (NDA) and
Investigational NDAs; the inherent uncertainty of outcomes in the
intellectual property disputes such as the dispute with the
University of Heidelberg regarding PSMA-617; our ability to
successfully develop and commercialize products that incorporate
licensed intellectual property; the effectiveness of the efforts of
our partners to market and sell products on which we collaborate
and the royalty revenue generated thereby; generic and other
competition; the possible impairment of, inability to obtain and
costs of obtaining intellectual property rights; possible product
safety or efficacy concerns, general business, financial,
regulatory and accounting matters, litigation and other risks; and
risks related to changes in the composition of our Board of
Directors following the delivery of shareholder consents in
response to the recent consent solicitation conducted by one of our
shareholders. More information concerning Progenics and such risks
and uncertainties is available on its website, and in its press
releases and reports it files with the Securities and Exchange
Commission (the “SEC”), including those risk factors included in
its Annual Report on Form 10-K for the year ended December 31,
2018, as updated in its subsequent Quarterly Reports on Form 10-Q.
Progenics is providing the information in this press release as of
its date and, except as expressly required by law, Progenics
disclaims any intent or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or circumstances or otherwise.
Additional information concerning Progenics and
its business may be available in press releases or other public
announcements and public filings made after this press release. For
more information, please visit www.progenics.com. Information on or
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ContactMelissa DownsInvestor
Relations(646) 975-2533mdowns@progenics.com
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