Flotufolastat F 18 Injection for Prostate Cancer Added to NCCN Guidelines

Flotufolastat F 18 injection (Posluma; formerly 18F-rhPSMA-7.3) has been added to The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in male patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or in men with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.¹

“The NCCN Guidelines are widely used by clinicians and health-care providers as a benchmark to assess clinical utility,” Eugene J. Teoh, MBBS, MRCP, FRCR, PhD, chief medical officer of Blue Earth Diagnostics, stated in a news release. “[Flotufolastat F 18] was developed to assist physicians in the detection and localization of prostate cancer. This update recognizes the important ability of PSMA-PET imaging procedures to detect and localize newly diagnosed and biochemically recurrent prostate cancer, which are essential to making appropriate patient management decisions.”

Flotufolastat F 18 is an optimized, high-affinity radiohybrid diagnostic imaging agent that aids in the identification of the location and extent of prostate cancer. This helps guide the management and treatment of patients with prostate cancer.

Previously in May 2023, the FDA approved flotufolastat F 18 injection for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum PSA level, based on findings from the phase 3 LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845) trials.^2,3

LIGHTHOUSE

In the multicenter, single-arm, LIGHTHOUSE trial, the use of the imaging agent was evaluated in 335 newly diagnosed patients with prostate cancer. Patients had unfavorable intermediate- to very high-risk prostate cancer and were set to undergo radical prostatectomy and pelvic lymph node dissection.

Once patients were enrolled, PET/CT was performed 50 to 70 minutes following a 296 MBq (8mCi) intravenous dose of 18F-rHPSMA-7.3.

Findings revealed that the detection of M1 lesions ranged from 16% to 28% across 3 blinded independent readers. A total of 10%-15% of patients had verified M1 lesions and by region, verified M1 lesions were most common in bone, ranging from 6.0%-11% across readers.

In LIGHTHOUSE, demonstrated that the imaging agent had high specificity for identifying pelvic lymph nodes compared with histopathology standard of truth in patients with PSMA-positive lesions before undergoing radical prostatectomy.

SPOTLIGHT

SPOTLIGHT was a multicenter, single-arm trial which sought to evaluate flotufolastat F 18 as a PET imaging agent in patients with suspected recurrence of prostate cancer based on elevated PSA levels following prior treatment.³ Male patients aged at least 18 years or older who received prior curative intent treatment for localized prostate cancer were eligible for enrollment in the study. Patients were also required to have elevated PSA and be eligible for salvage therapy.

Patients received 18F-rhPSMA-7.3 at a dose of 296 MBq/8 mCi, and PET/CT scans were given between 50 and 70 minutes after injection. Data from the study showed the agent to have high detection rates (88%) compared with a correct detection rate of 57%, even in patients with low PSA levels.

In a subset of 76 patients who received prior primary treatment and radiation for prostate cancer, the overall patient-level detection rate for PET imaging with flotufolastat F 18 was 99%. Scans were evaluated by 3 blinded central readers and across them, detection rates ranged from 93% to 100%. Looking at recurrence by region, rates were 76% for the prostate, 25% for pelvic lymph nodes, and 43% for extra-pelvic recurrences.

For safety,⁴ 4.1% of all 391 patients treated with flotufolastat F 18 had 1 or more treatment-emergent adverse event (AE) which was deemed related to or potentially related to the imaging agent. The most common AEs were hypertension (1.8%), diarrhea (1.0%), injection site reaction (0.5%), and headache (0.5%).

“The addition of [flotufolastat F 18] to the highly respected NCCN Guidelines is a major milestone for Blue Earth Diagnostics,” said David E. Gauden, PhD, chief executive officer of Blue Earth Diagnostics, in the press release. “We believe it further validates the clinical utility of [flotufolastat F 18] in patients with newly diagnosed or recurrent prostate cancer and can help expand patient access. In conjunction with our continuing efforts to increase United States commercial supply, Blue Earth is committed to make our new product widely available for patients and their physicians.”

References

1. Blue Earth Diagnostics announces addition of POSLUMA® (flotufolastat F 18) injection to NCCN clinical practice guidelines in oncology (NCCN Guidelines®) for prostate cancer. News release. Blue Earth Diagnostics. July 25, 2023. Accessed July 27, 2023. https://tinyurl.com/ywwctzbt

2. Blue Earth Diagnostics announces additional results from phase 3 LIGHTHOUSE trial of investigational PET imaging agent 18F-rhPSMA-7.3 in newly diagnosed prostate cancer. News release. Blue Earth Diagnostics. February 16, 2023. Accessed May 30, 2023. https://tinyurl.com/3dhxwb58

3. Schuster DM. Detection rate of 18F-rhPSMA-7.3 PET in patients with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). J Clin Oncol. 2022(suppl 6):9. doi:10.1200/JCO.2022.40.6_suppl.009

4. Jani AB, Ravizzini GC, Gartrell BA, et al. Diagnostic performance and safety of 18F-rhPSMA-7.3 positron emission tomography in men with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). J Urol. Published online August 1, 2023. doi:10.1097/JU.0000000000003493