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Patient Impact: Changes in staging OSPREY COHORT A and B

In OSPREY Cohort A,

26.9 %

(72/268) of patients at initial staging were upstaged¹*

1 out of 4 patients whose disease was shown to be localized by standard imaging were revealed to have N1 or M1 disease.

*Scans were assessed by 3 blinded, independent central readers.¹

In OSPREY Cohort B,

57.6 %

(19/33) of patients with no evidence of distance metastases on standard imaging were found to have PSMA-positive lesions and were upstaged^2†

^†Cohort B: 11 of 19 patients underwent targeted biopsy and 10/11 (91%) were confirmed to have prostate cancer on pathology.³

Study Limitation: OSPREY Cohort A was a single-arm study in high-risk, treatment-naive prostate cancer patients undergoing prostatectomy. Results may not be generalized to broader populations. Diagnostic performance was assessed using lesion-level histopathology and was not designed to evaluate clinical outcomes or infer causality. Formal hypothesis testing was not employed for Cohort B. Results are descriptive; no definitive conclusions can be made.

Patient Impact: Changes in treatment CONDOR

In CONDOR, data for change in intended treatment is based on 99% of enrolled patients in the pivotal CONDOR study (205 out of 208 patients)⁴

63.9 %

(131/205) of patients with BCR and with noninformative standard imaging had a change in intended management plan⁴

Nearly 2 out of 3 patients who underwent PSMA PET imaging after negative or uninformative standard imaging had a change in intended disease management based on findings of the scan.

Study Limitation: CONDOR was a prospective, single-arm study assessing intended management changes based on physician assessment without randomized comparators or evaluation of downstream clinical outcomes. Results were descriptive and based in a selected BCR population with limited histopathologic confirmation.

Following PSMA PET imaging results, the most frequent changes to treatment management plans in CONDOR were (N=205)⁴:

Salvage local therapy

Systemic therapy (n=58; 28.3%)

Systemic therapy

Salvage local therapy (n=43; 21.0%)

Planned treatment

Observation (n=9; 4.4%)

Observation

Initiating therapy (n=49; 23.9%)

39%

of patients with a baseline PSA of <0.5 ng/mL had a unidirectional change in planned management⁴

78.6%

(103/131) of the changes were based on positive PET/CT findings

21.4%

(28/131) of the changes were based on negative PET/CT findings

Change in management may prevent undertreatment or overtreatment

BCR=biochemically recurrent; CT=computed tomography; PET=positron emission tomography; PSA=prostate-specific antigen; PSMA=prostate-specific membrane antigen.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

INDICATION

PYLARIFY TRUVU (piflufolastat F 18) Injection is 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.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY TRUVU imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY TRUVU for imaging biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY TRUVU for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY TRUVU uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

PYLARIFY TRUVU exposes patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY TRUVU in prostate cancer. The effect of these therapies on performance of PYLARIFY TRUVU PET has not been established.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

REFERENCES

1. Carroll PR, Probst S, Rowe SP, et al. Changes to initial risk assessment and intended patient management in high-risk prostate cancer: an exploratory analysis of COHORT A from the OSPREY trial. J Urol. 2021;206(suppl3):e181-e182. 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). J Urol. 2021;206(1):52-61. 3. Durack JC, Alva AS, Preston MA, et al. A prospective phase II/III study of PSMA-targeted ¹⁸F-DCFPyL-PET/CT in patients (pts) with prostate cancer (PCa) (OSPREY): a subanalysis of disease staging changes in PCa pts with recurrence of metastases on conventional imaging. Presented at: 2021 ASCO Genitourinary Cancers Symposium: February 11-13, 2021. 4. 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. Clin Cancer Res. 2021;27(13):3674-3682.