Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting
May 16 2022 - 8:00AM
Lantheus Holdings, Inc. (“the Company”) (NASDAQ: LNTH), an
established leader and fully integrated provider committed to
innovative imaging diagnostics, targeted therapeutics and
artificial intelligence solutions to Find, Fight and Follow serious
medical conditions, presented results from a retrospective analysis
of quantitative PYLARIFY® (piflufolastat F18) PSMA scan indices as
a response imaging-biomarker to androgen deprivation therapy in
veterans with newly diagnosed metastatic prostate cancer.
Using PYLARIFY AI™ to locate PSMA-avid lesions and
track changes over time, investigators were able to determine that
the change in the automated PSMA scan indices for total lesion
volume, and also separately in bone and lymph node were all
significantly consistent with PSA response following therapy. The
findings support further exploration of PYLARIFY AI as a tool to
quantify treatment response not only in at the overall disease
burden but also at the lesion level.
“PSMA imaging is quickly becoming an essential tool
in our management of prostate cancer and PYLARIFY AI has the
ability to reproducibly and rapidly quantify disease burden. I
think it can be used to address many limitations of conventional
imaging including in the assessments of response to therapy,” said
Nicholas G. Nickols, MD, PhD, Associate Professor in Radiation
Oncology at UCLA, who led the study and presented the findings. “Of
particular interest, this study reveals a method for measuring
treatment response in bone using PSMA PET imaging, which may
ultimately lead to improving patient outcomes.”
The study included a retrospective analysis of 30
treatment naïve prostate cancer patients who had undergone androgen
deprivation therapy with and without radiation. PSMA scans were
performed prior to treatment and at least six months after
initiation of treatment. The images of all patients were analyzed
by PYLARIFY AI which was used to locate PSMA-avid lesions and track
changes over time. The continuous change in quantitative PSMA
indices was compared with the change in PSA. At treatment
follow-up, patients had an average PSA decline of 97% (median PSA
0.02). Concurrently, the changes in total PSMA indices in lymph
node (average decline 80%; IQR: 62% to 100%) and in bone (average
decline: 51%; IQR: 14% to 87%) were found to be significantly
associated with PSA decline (r=0.74; p=0.0001).
“As the use of PSMA PET imaging becomes more
widespread and used to guide treatment decisions, capturing the
data to produce quantifiable and reproducible insights across the
treatment spectrum will be essential,” said Jean-Claude Provost,
MD, Interim Chief Medical Officer, Lantheus. “This study
demonstrates the power of PYLARIFY AI in augmenting the value of
each scan and highlights the role PYLARIFY AI may play in assisting
clinicians in determining the best path forward for treating
individual patients.”
About Prostate CancerProstate
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 2022, almost 268,500 new cases of
prostate cancer will be diagnosed, and about 34,500 men will die of
the disease. Approximately 3.1 million men in the United States
currently count themselves as prostate cancer survivors.1
About PYLARIFY AI™PYLARIFY AI™
employs a deep learning algorithm that has been trained and
validated across more than 3,000 images to allow healthcare
professionals and researchers to perform standardized quantitative
assessment of PSMA PET/CT images in prostate cancer. Through
rigorous analytical and clinical studies, PYLARIFY AI has
demonstrated improved consistency, accuracy and efficiency in
quantitative assessment of PSMA PET/CT. An FDA-cleared medical
device software, PYLARIFY AI V1.0 is commercially available in the
United States.
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 committed to 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; PYLARIFY®, a PSMA PET imaging agent for the detection
of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™,
an artificial intelligence platform that assists in the evaluation
of PSMA PET images; 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 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 “believe,” “can,” “could,” “estimate,”
“intend,” “may,” “target,” “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) the Company’s ability to
successfully launch PYLARIFY AI as a commercial product; (ii) the
market receptivity to PYLARIFY AI as a new digital application for
quantitative assessment of PSMA PET/CT images in prostate cancer;
(iii) the intellectual property protection of PYLARIFY AI; (iv)
interruptions or performance problems associated with our digital
application, including a service outage; (v) a network or data
security incident that allows unauthorized access to our network or
data or our customers’ data; and (vi) the risks 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), including, but not limited to those related to
PYLARIFY.
1American Cancer Society. Facts & Figures 2022.
American Cancer Society. Atlanta, GA. 2022.
Contacts:Mark KinarneySenior
Director, Investor Relations978-671-8842ir@lantheus.com
Melissa Downs Senior Director, Corporate
Communications646-975-2533media@lantheus.com
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