OSPREY Phase 2/3 Results Published in the
Journal of Urology
CONDOR Phase 3 Results Published in Clinical
Cancer Research
Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an
established leader and fully integrated provider of innovative
imaging diagnostics, targeted therapeutics and artificial
intelligence solutions to Find, Fight and Follow serious medical
conditions, today announced the publication of the results of both
pivotal studies for PyL™, an investigational PET imaging agent that
targets prostate-specific membrane antigen (PSMA). The OSPREY Phase
2/3 trial results have been published online in the Journal of
Urology and the CONDOR Phase 3 trial results have been published in
the online version of Clinical Cancer Research.
“The limitations of conventional imaging modalities for prostate
cancer create a need for targeted imaging in the initial assessment
of high-risk patients as well as in men with early biochemically
relapsed disease,” said Michael J. Morris, M.D., Prostate Cancer
Section Head, Genitourinary Medical Oncology Service, Division of
Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and
lead author of the CONDOR manuscript and senior author on the
OSPREY manuscript. “The OSPREY trial data highlighted the high
positive predictive value, negative predictive value and
specificity of PyL in staging high-risk patients. The CONDOR trial
demonstrates its high positive predictive value to accurately
locate and identify recurrent cancer early and non-invasively.
Assuming FDA approval, physicians will be able to use this
clinically meaningful information to identify disease, guide
treatment plans, and improve disease management.”
Mary Anne Heino, President and Chief Executive Officer of
Lantheus added, “We believe these data demonstrate PyL’s clinical
benefit and are honored to have our studies published in such
well-respected peer-reviewed journals. The results of the OSPREY
and CONDOR trials are part of our NDA that is currently under
priority review at the FDA for marketing authorization in the
United States. We believe PyL has the potential to play an
important role in transforming the management of men with
high-risk, recurrent or metastatic prostate cancer.”
Kenneth J. Pienta, M.D., Director of Research at the James
Buchanan Brady Urological Institute and Professor of Urology at
Johns Hopkins University School of Medicine, was the lead author of
the OSPREY manuscript. The OSPREY publication in the Journal of
Urology may be found online here.
Michael J. Morris, M.D., Prostate Cancer Section Head of the
Genitourinary Medical Oncology Service and Division of Solid Tumor
Oncology at Memorial Sloan Kettering Cancer Center. Was the lead
author of the CONDOR manuscript. The CONDOR publication in Clinical
Cancer Research may be found online here.
OSPREY Phase 2/3 Trial The
OSPREY trial was designed to assess the diagnostic performance of
PyL to detect prostate cancer in pelvic lymph nodes in subjects
with high-risk prostate cancer (Cohort A) and confirm distant
metastases in subjects with metastatic or recurrent prostate cancer
(Cohort B). The primary endpoints for the trial were sensitivity
and specificity of PyL PET/CT imaging to detect metastatic prostate
cancer within the pelvic lymph nodes relative to histopathology in
Cohort A. A key secondary endpoint of the trial was the sensitivity
of PyL PET/CT imaging to detect prostate cancer within sites of
metastasis or local recurrence relative to histopathology in Cohort
B.
In the trial, the diagnostic performance of PyL in detecting
disease in pelvic lymph nodes (Cohort A) was compared with
histopathology. PyL showed specificity of 96-99%, sensitivity of
31-42%, and PPV of 78-91% meeting the specificity but not the
pre-established sensitivity co-primary endpoint. In the metastatic
or recurrent prostate cancer setting (Cohort B), PyL exhibited
sensitivity of 93-99% and PPV of 81-88% in detecting metastatic
lesions. Overall, PyL demonstrated high diagnostic performance in
reliably detecting nodal and distant metastatic prostate
cancer.
Safety results showed PyL was well tolerated. The most frequent
adverse events reported were dysgeusia (2.6%), headache (1.8%), and
fatigue (1.3%).
CONDOR Phase 3 Trial The
CONDOR trial was designed to assess the diagnostic performance and
clinical utility of PyL in men with biochemically recurrent
prostate cancer and uninformative standard imaging. The primary
endpoint in the trial was the Correct Localization Rate (CLR) of
PyL. 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 PyL PET/CT and a
composite truth standard. The composite truth is comprised of, in
descending priority, histopathology, subsequent correlative imaging
findings, or PSA response following radiation therapy. The key
secondary endpoint in the trial was the percent of subjects with a
change in intended prostate cancer treatment due to PyL imaging
results.
The CONDOR trial achieved its primary endpoint, with a 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%). In the key secondary endpoint, 63.9% of patients had a
change in intended prostate cancer treatment following review of
PyL imaging results. The most frequent changes in intended prostate
cancer treatment plans included changing salvage local therapy to
systemic therapy, observation to initiating therapy, noncurative
systemic therapy to salvage curative local therapy and planned
treatment to observation.
Safety results showed PyL was well tolerated. The most frequent
adverse event reported was headache, which was reported in four
patients (1.9% of the trial population). There was one serious
adverse event of hypersensitivity reported as related to the study
drug.
About Prostate Cancer Prostate cancer is the second most
common form of cancer affecting men in the United States -- an
estimated one in eight men will be diagnosed with prostate cancer
in their lifetimes. The American Cancer Society estimates that in
2021, 248,530 new cases of prostate cancer will be diagnosed, and
34,130 men will die of the disease. Approximately 3.1 million men
in the United States currently count themselves as prostate cancer
survivors.1
About PyL PyL (also known as 18F-DCFPyL) is an
investigational fluorinated PSMA-targeted PET imaging agent that
enables visualization of localized prostate cancer both localized
as well as metastatic to lymph nodes, bone and soft tissue to
detect and localize recurrent and/or metastatic prostate cancer. On
September 29, 2020, Lantheus submitted a new drug application (NDA)
for PyL which was accepted and granted priority review and assigned
a Prescription Drug User Fee Act (PDUFA) action date of May 28,
2021.
About Lantheus Holdings, Inc. Lantheus Holdings, Inc. is
the parent company of Lantheus Medical Imaging, Inc., Progenics
Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established
leader and fully integrated provider of innovative imaging
diagnostics, targeted therapeutics and artificial intelligence
solutions to Find, Fight and Follow™ serious medical conditions.
Lantheus provides a broad portfolio of products, including the
echocardiography agent DEFINITY® Vial for (Perflutren Lipid
Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m
Generator), a technetium-based generator that provides the
essential medical isotope used in nuclear medicine procedures;
AZEDRA® for the treatment of certain rare neuroendocrine tumors;
and RELISTOR® for the treatment of opioid-induced constipation,
which is partnered with Bausch Health Companies, Inc. The Company
is headquartered in North Billerica, Massachusetts with offices in
New York, New Jersey, Canada and Sweden. For more information,
visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, that are subject to risks and uncertainties and are made
pursuant to the safe harbor provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
statements may be identified by their use of terms such as
“expect,” “intend,” “will” and other similar terms. Such
forward-looking statements are based upon current plans, estimates
and expectations that are subject to risks and uncertainties that
could cause actual results to materially differ from those
described in the forward-looking statements. The inclusion of
forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Readers are cautioned not to place undue reliance on the
forward-looking statements contained herein, which speak only as of
the date hereof. The Company undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by law. Risks and uncertainties that could cause our
actual results to materially differ from those described in the
forward-looking statements include (i) a delay in obtaining, or
failure to obtain, a positive regulatory outcome from the FDA and
other regulatory authorities for PyL; (ii) the Company’s ability to
successfully launch PyL as a commercial product; (iii) the market
receptivity to PyL as a new diagnostic agent; (iv) the safety and
efficacy of PyL; (v) the intellectual property protection of PyL;
and (vi) the risk and uncertainties discussed in our filings with
the Securities and Exchange Commission (including those described
in the Risk Factors section in our Annual Reports on Form 10-K and
our Quarterly Reports on Form 10-Q).
1 American Cancer Society. Facts & Figures 2021. American
Cancer Society. Atlanta, GA. 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20210301005231/en/
Mark Kinarney Senior Director, Investor Relations 978-671-8842
ir@lantheus.com
Melissa Downs Director, Corporate Communications 646-975-2533
media@lantheus.com
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