PYLARIFY® PET/CT significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV2
In a post-hoc analysis, PYLARIFY® achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm2
- In the pre-specified analysis, the specificity co-primary endpoint with PYLARIFY® (piflufolastat F 18) injection PET/CT was met (the lower limits of the 95% CIs for all readers were >80%), but the sensitivity co-primary endpoint was not met, in part due to limitations in PET/CT image resolution for tumors smaller than 5 mm2,4,5
- PYLARIFY® PET/CT achieved high PPV (range: 72%-81%) and NPV (81%-84%)3
PYLARIFY® achieved high PPV, specificity, and NPV compared to standard imaging while maintaining comparable sensitivity2
- PYLARIFY® PET/CT specificity was significantly higher than with standard imaging (97.9% vs 65.1%)
- PYLARIFY® PET/CT nearly tripled the PPV compared to standard imaging (86.7% vs 28.3%)
- PYLARIFY® PET/CT achieved similar sensitivity to standard imaging
OSPREY was a robust, prospective, multicenter phase 2/3 clinical trial including 268 men with high-risk prostate cancer prior to initial definitive therapy
OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT
In Cohort A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores†
†n=268; except for Distant Metastases (n=266) and Median PSA (n=267).
‡Stage at time of study entry or most recent prior to entry.
PYLARIFY® PET/CTs' HIGH PPV AND
NPV RATES INDICATE THAT A
POSITIVE OR NEGATIVE RESULT FOR NODAL DISEASE IS MORE INFORMATIVE THAN STANDARD IMAGING,
allowing physicians to treat with more confidence2REVIEW CASE STUDIES FROM
PYLARIFY® CLINICAL TRIALS
CI=confidence interval; PLND=pelvic lymph node dissection; CT=computed tomography; NPV=negative predictive value; PCa=prostate cancer; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; PSMA=prostate-specific membrane antigen.
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.
- FDA clearance letter for aPROMISE. Food and Drug Administration. July 27, 2021.
- Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPYL in prostate cancer patients (OSPREY) [published online ahead of print, February 26, 2021]. J Urol. doi:10.1097/JU.0000000000001698
- PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
- Crippa F, Leutner M, Belli F, et al. Which kinds of lymph node metastases can FDG PET detect? A clinical study in melanoma. J Nucl Med. 2000;41(9):1491-1494.
- Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14. doi:10.1177/1758835919876828