IN PATIENTS WITH HIGH-RISK PROSTATE CANCER WHO WERE CANDIDATES FOR INITIAL DEFINITIVE THERAPY,

PYLARIFY® PET/CT significantly improved specificity over conventional 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

Chart showing PYLARIFY® achieved high specificity, PPV, and NPV
  • 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 conventional imaging while maintaining comparable sensitivity2

  • PYLARIFY® PET/CT specificity was significantly higher than with conventional imaging (97.9% vs 65.1%)
  • PYLARIFY® PET/CT nearly tripled the PPV compared to conventional imaging (86.7% vs 28.3%)
  • PYLARIFY® PET/CT achieved similar sensitivity to conventional imaging
Review the clinical trial design for the OSPREY trial2

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

Clinical trial design for the Osprey trial

In Cohort A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores

Clinical trial design for the Osprey trial Clinical trial design for the Osprey trial
Clinical trial design for the Osprey trial Clinical trial design for the Osprey trial

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 CONVENTIONAL IMAGING,

allowing physicians to treat with more confidence2

REVIEW 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.

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.

References

  1. FDA approval letter for aPROMISE. Food and Drug Administration. July 27, 2021.
  2. 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
  3. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
  4. 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.
  5. 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