IN PATIENTS WITH RECURRENT PROSTATE CANCER BASED ON ELEVATED SERUM PSA,

PYLARIFY® PET/CT achieved the primary endpoint of correct localization rate: 85%-87% across all 3 readers (lower bound of 95% CI: 78%-80%)1

This result significantly exceeds the FDA-recommended threshold, which was defined as the lower bound of 95% CI exceeding 20% for at least 2 of the 3 readers1,2

Table showing that PYLARIFY® achieved the primary endpoint of correct localization rate across all 3 readers Table showing that PYLARIFY® achieved the primary endpoint of correct localization rate across all 3 readers
  • CLR was the location-matched positive predictive value in the Evaluable Set (true positive/[true positive + false positive])1
  • Imputed CLR was the location-matched positive predictive value in all scanned patients using an imputation approach based on patient-specific factors for patients who were PET-positive without reference standard1

CLR is a measure of positive predictive value enhanced with precise anatomic location of site of disease2

  • CLR is based on anatomic lesion matching, or co-localization, of lesions identified by PYLARIFY® and lesions identified by the standard of truth (SOT)
  • The correct localization rate was defined as the percentage of patients with a 1:1 correspondence between at least 1 lesion identified on PYLARIFY® and on the standard of truth
Diagram explaining how correct localization rate improves on PPV as an endpoint

*SOT is hierarchically defined either as:

  • Evaluable local histopathology findings for prostate cancer from surgery/biopsy, or
  • Informative conventional imaging (eg, 18F fluciclovine PET [preferred if not performed at baseline] or choline PET; targeted MRI/CT), or
  • PSA response per central lab analysis in subjects treated with RT only (no concomitant ADT) following PYLARIFY® PET/CT imaging
  • PYLARIFY® (piflufolastat F 18) injection CLR remained high regardless of which imaging modality was used as the standard of truth2:
    • 18F fluciclovine PET/CT (n=71): 86.8%-90.9% across the 3 readers
    • MRI (n=23): 80.0%-86.7% across the 3 readers
    • CT (n=6): 80.0%-100% across the 3 readers

PYLARIFY® PET/CT demonstrated high CLR independent of baseline PSA levels2

PYLARIFY® PET/CT demonstrated high CLR independent of baseline PSA levels

Detection rates for PYLARIFY® PET/CT rose with increasing PSA levels (36.2% at <0.5 ng/mL to 96.7% at ≥5 ng/mL)2

Detection rates for PYLARIFY® PET/CT rose with increasing PSA levels
Review the clinical trial design for the CONDOR trial2

CONDOR was a robust, multicenter, phase 3 trial of 208 patients with suspected recurrent or metastatic prostate cancer with negative or equivocal results using conventional imaging

CONDOR assessed correct localization rate (CLR)—an improved metric for evaluating diagnostic performance compared to PPV—in men with biochemically recurrent prostate cancer

Clinical trial design for the Condor Trial

REFERENCE STANDARDS OF TRUTH IN CONDOR

Because most patients were not expected to have an amenable lesion for histological verification, a composite standard of truth was discussed with the FDA based on these reference standards (in order of priority):

  1. Evaluable histopathology results from prostatectomy, salvage pelvic lymph node dissection, or targeted biopsy
  2. Correlative follow-up imaging findings using 18F-fluciclovine or 11C-choline PET, or focused MRI or CT
  3. If neither of the above was available or informative, confirmed PSA response up to 9 months post-radiation initiation (without concomitant ADT) of all PET-positive foci

PSA response was defined as PSA decline by ≥50% from baseline that was confirmed on repeat measurement within 4 weeks, based on central laboratory results.


CONDOR included patients with a broad range of PSA levels and Gleason scores

Clinical trial design for the Condor Trial Clinical trial design for the Condor Trial
Clinical trial design for the Condor Trial Clinical trial design for the Condor Trial

REVIEW CASE STUDIES FROM PYLARIFY® CLINICAL TRIALS

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CI=confidence interval; CLR=correct localization rate; CT=computed tomography; PCa=prostate cancer; PET=positron emission tomography; PSA=prostate-specific antigen; RP=radical prostatectomy; BCR=biochemical recurrence; RT=radiation therapy.

IMPORTANT SAFETY
INFORMATION

Contraindications

None.

Warnings and Precautions

References

  1. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company
  2. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPYL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study [published online ahead of print, February 23, 2021]. Clin Cancer Res. doi:10.1158/1078-0432.CCR-20-4573