NORTH BILLERICA, Mass., Sept. 10, 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 that data from the OSPREY pivotal trial on the utility of piflufolastat F 18 (previously referred to as 18F-DCFPyL or PyL) during initial assessment on men with high risk prostate cancer were presented at the 2021 American Urological Association (AUA) Virtual Annual Meeting. Piflufolastat F 18 is Lantheus’ prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent.
The OSPREY study evaluated the diagnostic performance of piflufolastat F 18 PET/CT using a histopathology truth standard in men with newly diagnosed prostate cancer. A single dose of 9 mCi (333 MBq) of piflufolastat F 18 was administered via intravenous injection, followed by PET/CT acquisition 1 to 2 hours thereafter. 268 men with a median PSA 9.7 (range 1.2-125.3, n=267) underwent a piflufolastat F 18 PET/CT scan. After a piflufolastat F 18 PET/CT scan, 72 (26.9%) patients had regional lymph node and/or distant metastases identified and were radiographically staged with 39 (14.6%) as N1/M0 and 33 (12.3%) as N0/M1 or N1/M1 disease.
In addition, the Company also presented at the meeting the results of an independent, retrospective review to assess the impact of piflufolastat F 18 imaging on the planned management of the patients in the trial. A multidisciplinary panel, consisting of an independent urologist, medical oncologist and radiation oncologist, assessed the patients’ clinical profiles and conventional imaging data before reviewing the patients’ piflufolastat F 18 imaging data. Incorporation of the piflufolastat F 18 results led to a potential change in planned management for 43.6% (115/264) of patients. In 39.0% (103/264), a change in surgery or type of surgery was recommended and in 25.8% (68/264), a change in planned radiation therapy was recommended.1
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“In the OSPREY trial, in patients selected for radical prostatectomy, piflufolastat F 18 was able to detect disease outside of the prostate in nearly one-third of the cases,” said Peter Carroll, MD, MPH, Professor of Urology at University of California San Francisco. “These results suggest that PSMA imaging may have a substantial impact on management decisions at the time of initial assessment in men at risk for metastasis.”