Collaboration aims to make flotufolastat F 18 available in China for prostate cancer imaging

Blue Earth Diagnostics has entered into a partnership with Sinotau Pharmaceutical Group to make its PSMA-PET imaging agent flotufolastat F 18 (US trade name, Posluma) available for use in patients with prostate cancer in China.¹

According to Blue Earth, “there are no 18F-labeled PSMA-PET diagnostic radiopharmaceuticals available” in the domestic market in China.¹ The company also noted in a news release that the 2022 Prostate Cancer Diagnosis and Treatment Guidelines from the Chinese Society of Clinical Oncology suggest that PSMA-PET imaging is appropriate to use to evaluate patients with prostate cancer receiving definitive treatment; to diagnose and locate biochemical recurrence following radical prostatectomy or radiotherapy; and to assess the efficacy of systemic treatments for prostate cancer.

The primary support for the clinical use of flotufolastat F 18 in patients with prostate cancer comes from the phase 3 SPOTLIGHT and LIGHTHOUSE trials.

“We are delighted to have this new agreement in place with Sinotau, to make innovative flotufolastat (18F) PET imaging available to the Chinese community,” David E. Gauden, DPhil, CEO of Blue Earth Diagnostics, stated in the news release.¹ “Flotufolastat (18F) represents a new class of PSMA-targeted PET radiopharmaceuticals that are based on novel radiohybrid technology. It is engineered to advance clinical decision-making by providing useful information to guide treatment planning in men with prostate cancer. We believe that the demonstrated diagnostic performance of flotufolastat (18F), with its high-affinity PSMA binding and low urinary bladder activity, make it a valuable diagnostic tool for markets around the world.”

In the United States, flotufolastat F 18 is approved by the FDA for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.² It is now included in the NCCN guideline recommendations for all the same categories as the other PSMA-PET imaging agents approved by the FDA.³

The FDA approved flotufolastat F 18 based on findings from the phase 3 SPOTLIGHT and LIGHTHOUSE trials, and much of the same data was considered by the NCCN panel that added the imaging agent to the prostate cancer guidelines.

SPOTLIGHT

The multicenter, single-arm, phase 3 SPOTLIGHT study (NCT04186845) examined the safety and diagnostic performance of flotufolastat F 18 injection as a PET imaging product in men who had suspected prostate cancer recurrence based on elevated PSA after previous therapy.⁴

The efficacy population included 389 patients with an evaluable PET scan. The mean patient age was 68 years (range, 43-86) and the median baseline PSA serum level was 1.1 ng/mL.⁴

The flotufolastat F 18 scans were evaluated independently by 3 blinded central readers. Across all 3 readers, 46% to 60% of the regions determined to be positive for prostate cancer recurrence on the flotufolastat F 18 scan were also determined to be positive based on the reference standard. According to the product labeling, the reference standard consisted of “other imaging evaluated by a separate consensus panel or histopathology.”⁴

LIGHTHOUSE

The prospective, multicenter, single-arm, phase 3 LIGHTHOUSE study (NCT04186819) examined flotufolastat F 18 injection in patients with newly diagnosed prostate cancer. Patients enrolled in the trial had unfavorable intermediate-risk (about one-third) or high-/very high-risk (about two-thirds) prostate cancer.⁴

In this study, there were 296 patients (mean age, 65 years; range, 46-82) who received standard prostatectomy and pelvic lymph node dissection. Of these patients, histopathology showed that around 24% had pelvic lymph node metastases.⁴

Flotufolastat F 18 scans were evaluated independently by 3 blinded readers. The performance of flotufolastat F 18 was compared with “histopathology after matching by hemipelvis,” according to the product labeling.⁴

The results showed that flotufolastat F 18 had a low sensitivity for predicting positive lymph nodes. The sensitivity among the 3 readers ranged from 23% to 30%. However, flotufolastat F 18 rated high for specificity with a range of 93% to 97% among the readers.⁴

Commenting on the partnership with Blue Earth in the news release, Yanmin Tang, CEO of Sinotau, stated, “Sinotau Pharmaceutical Group is dedicated to the field of new generation radiopharmaceuticals. We are pleased to form this strategic cooperation with Blue Earth Diagnostics and we look forward to making flotufolastat (18F) available to the clinical community in China. In the future, Sinotau Pharmaceutical Group will continue to make clinically valuable and excellent radiopharmaceuticals available to benefit more Chinese patients.”¹

References

1. Blue Earth Diagnostics Ltd Collaborates with Sinotau Pharmaceutical Group to Bring Prostate Cancer PET Diagnostic Imaging Agent, Flotufolastat (18F) Injection, to China. Published online and accessed October 17, 2023. https://tinyurl.com/uxxjdzr7

2. U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA® (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer. Accessed May 30, 2023. https://tinyurl.com/mpbdk5br

3. Blue Earth Diagnostics Announces Addition of POSLUMA® (Flotufolastat F 18) Injection to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. Accessed July 26, 2023. https://www.businesswire.com/news/home/20230725319846/en

4. Highlights of prescribing information. POSLUMA (flotufolastat F 18) injection, for intravenous use. Initial U.S. Approval: 2023. https://www.posluma.com/prescribing-information.pdf