Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting

Rhea-AI Summary

Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that data from the OSPREY pivotal trial will be presented at the 2022 ASCO GU Meeting on February 17, 2022, in San Francisco, CA. The presentation will cover the performance of Piflufolastat F 18-PET/CT in prostate cancer patients, specifically analyzing standardized uptake value results based on PSA and Gleason scores. PYLARIFY is highlighted as a PSMA-targeted PET imaging agent for identifying recurrent and metastatic prostate cancer. This data presentation is a key opportunity to showcase Lantheus's advancements in oncology diagnostics.

Positive

• Data from the OSPREY trial selected for presentation at a prominent medical conference.
• PYLARIFY (piflufolastat F 18) is recognized for its efficacy in diagnosing prostate cancer.

Negative

• Potential for imaging misinterpretation with PYLARIFY, affecting diagnostic reliability.

NORTH BILLERICA, Mass., Feb. 10, 2022 (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 that data from the OSPREY pivotal trial has been selected for presentation at the upcoming 2022 American Society for Clinical Oncology Genitourinary (ASCO GU) Meeting, which will be held February 17-19, 2022 in San Francisco, CA.

Presentation details are as follows:

Date & Time: February 17, 2022, 11:30 – 1:00 PM PT and 5:45 – 6:45 PM PT
Session Title: Poster Session A: Prostate Cancer
Title: Piflufolastat F 18-PET/CT in Prostate Cancer (PCa) Patients (Pts): An Analysis of OSPREY (Cohorts A and B) Standardized Uptake Value (SUV) Results Stratified by PSA and Gleason Score (GS)
Presenter: Michael Gorin, M.D., Urology Associates & UPMC Western Maryland
Abstract No: 35

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.^4-9

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; 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.

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 the significance of the OSPREY trial data for Lantheus Holdings (LNTH)?

The OSPREY trial data is significant as it will be presented at the 2022 ASCO GU Meeting, showcasing Lantheus's advancements in prostate cancer diagnostics.

When will the OSPREY trial data be presented?

The OSPREY trial data will be presented on February 17, 2022, during the ASCO GU Meeting.

What is PYLARIFY and its role in prostate cancer diagnosis for LNTH?

PYLARIFY is a PSMA-targeted PET imaging agent developed by Lantheus for the diagnosis of recurrent and metastatic prostate cancer.

What are the potential risks associated with PYLARIFY imaging?

Potential risks include image misinterpretation and variability in performance based on PSA levels.