Lantheus Holdings Announces Presentations Featuring PYLARIFY® (Piflufolastat F 18), its PSMA-Targeted Prostate Cancer Imaging Agent, at Key Scientific Meetings

Rhea-AI Summary

Lantheus Holdings (NASDAQ: LNTH) announced that data from the Phase 3 CONDOR study on PYLARIFY® (piflufolastat F 18) will be presented at two significant medical conferences. The first is the RSNA meeting in Chicago from November 28 to December 2, 2021, featuring a poster discussion on diagnostic performance in prostate cancer recurrence. The second is the SUO meeting in Orlando from December 1-3, 2021, also focusing on PYLARIFY’s performance post-treatment. PYLARIFY is crucial for detecting prostate cancer and its PET imaging capabilities have garnered attention for their accuracy and efficacy.

Positive

• Presentation of PYLARIFY data at two major conferences may enhance visibility and drive interest in the product.
• The CONDOR study's focus on prostate cancer recurrence reflects Lantheus's commitment to addressing critical medical needs.

Negative

• Potential risks associated with PYLARIFY imaging, including the possibility of misinterpretation of images, which may affect diagnosis.
• Adverse reactions reported during clinical studies, such as headaches and fatigue, may deter some healthcare providers from using PYLARIFY.

NORTH BILLERICA, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- 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, announced today poster presentations featuring PYLARIFY^® (piflufolastat F 18) data from the Company’s Phase 3 CONDOR study at the upcoming Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), which will be held from November 28 - December 2, 2021 in Chicago, IL and the 22^nd Annual Meeting of the Society for Urologic Oncology (SUO), which will be held from December 1-3, 2021 in Orlando, FL.

Details for the RSNA presentation are as follows:
Date/Time: November 30, 2021 4:30 – 5:00 PM CT
Session Title: Genitourinary Tuesday Poster Discussions (Session ID: GU03-D)
Title: Assessment of Diagnostic Performance with 18F-DCF-PYL PET/CT in Men with Suspected Recurrence of Prostate Cancer: A CONDOR Study Subanalysis Comparing Central and Local Reader Results
Presenter: Kenneth L. Gage, MD, PhD, Diagnostic Imaging and Interventional Radiology
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
Abstract No: 8988

Details for the SUO presentation are as follows:
Date/Time: Friday, December 3, 2021 3:00 – 4:00 PM ET
Title: Diagnostic Performance of Piflufolastat F 18 PET/CT in Men with Biochemical Recurrence of Prostate Cancer After Definitive Treatment: A CONDOR Study Subanalysis
Presenter: Peter Carroll, MD, MPH, Professor of Urology at University of California San Francisco
Abstract No: 219

About PYLARIFY^® (piflufolastat F 18) Injection
PYLARIFY^® (piflufolastat F 18) injection (also known as ¹⁸F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.^1-6

PYLARIFY^® (piflufolastat F 18) Injection
Indication
PYLARIFY^® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• with suspected metastasis who are candidates for initial definitive therapy.
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Important Safety Information
Contraindications
None.

Warnings and Precautions
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

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; 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.

¹Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689
²Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.
³Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.
⁴Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.
⁵Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290
⁶PYLARIFY^® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

Contacts:
Mark Kinarney
Senior Director, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Director, Corporate Communications
646-975-2533
media@lantheus.com

FAQ

What is Lantheus Holdings' role in prostate cancer diagnostics?

Lantheus Holdings is a leader in providing innovative imaging diagnostics, specifically through its product PYLARIFY, which is used for detecting recurrent and metastatic prostate cancer.

When are the presentations for PYLARIFY taking place?

The presentations will occur at the RSNA from November 28 to December 2, 2021, and at the SUO from December 1-3, 2021.

What significant study data will Lantheus present at the RSNA?

Lantheus will present data from the Phase 3 CONDOR study regarding the diagnostic performance of PYLARIFY in detecting prostate cancer recurrence.

What are the potential adverse reactions of using PYLARIFY?

The most frequently reported adverse reactions include headaches, dysgeusia, and fatigue, occurring at a rate of ≤2% in clinical studies.

What is PYLARIFY used for?

PYLARIFY is used as a diagnostic agent for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.