Lantheus Announces Presentation at the 2021 American Urological Association (AUA) Annual Meeting
Highlights Piflufolastat F 18’s Potential to Change Initial Risk Assessment and Intended Patient Management in High-Risk Prostate Cancer
Identified Regional Lymph Node and/or Distant Metastases in 26.9% of Patients Prior to Definitive Therapy
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
“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.”
“Proper patient selection for any therapy is critical,” said Bela Denes, MD, Vice President of Medical Affairs at Lantheus. “This analysis of the OSPREY data further supports the utility of piflufolastat F 18 in men with suspected metastasis prior to definitive therapy and its potential impact on treatment recommendations.”
OSPREY Phase 2/3 Trial
OSPREY enrolled a cohort of 268 men with biopsy-proven prostate cancer who were considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients were all considered to have high risk disease based on criteria such as Gleason score, PSA level, and tumor stage. Each patient received a single piflufolastat F 18 PET/CT scan from mid-thigh to skull vertex.
Three central readers independently interpreted each PET scan for the presence of abnormal piflufolastat F 18 uptake in pelvic lymph nodes in multiple sub-regions, including the common iliac lymph nodes. The readers were blinded to all clinical information. While readers also recorded the presence of piflufolastat F 18 PET-positive lesions in the prostate gland and outside the pelvis, those results were not included in the primary efficacy analysis.
A total of 252 patients (94%) underwent standard-of-care prostatectomy and template pelvic lymph node dissection and had sufficient histopathology data for evaluation of the pelvic lymph nodes. Surgical specimens were separated into three regions: left hemipelvis, right hemipelvis, and other. For each patient, piflufolastat F 18 PET results and histopathology results obtained from dissected pelvic lymph nodes were compared by surgical region. PET results in locations that were not dissected were excluded from analysis.
For the 252 evaluable patients, the mean age was 64 years (range 46 to 84 years), and 87% were white. The median serum PSA was 9.3 ng/mL. The total Gleason score was 7 for 19%, 8 for 46%, and 9 for 34% of the patients, with the remainder of the patients having Gleason scores of 6 or 10.
In the trial, the diagnostic performance of piflufolastat F 18 in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. When matched by lymph node location, piflufolastat F 18 showed specificty of 95-98%, sensitivity of 28-39%, and positive predictive value (PPV) of 72-81% meeting the specificity but not the pre-established sensitivity co-primary endpoint.
Safety results showed piflufolastat F 18 was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%) and fatigue (1.3%).2
About Prostate Cancer
About PYLARIFY® (piflufolastat F 18) Injection
PYLARIFY® (piflufolastat F 18) Injection
Important Safety Information
Warnings and Precautions
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.
Safe Harbor for Forward-Looking and Cautionary Statements
1Changes in treatment plan do not necessarily lead to improved patient outcomes.
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