October 25, 2016 — Blue Earth Diagnostics Ltd. announced the peer-reviewed publication of results from a Phase 3 clinical trial of Axumin (fluciclovine F 18) injection. Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate-specific antigen (PSA) following prior treatment. Results of the multi-center study, conducted in Norway, Italy and the United States, demonstrated a 68 percent overall detection rate (DR) for Axumin, with the ability to detect local, as well as distant, prostate cancer recurrence across a wide range of PSA values. Axumin was well-tolerated in the study.
The manuscript, “Multi-site experience of the safety, detection rate and diagnostic performance of fluciclovine (18F) PET/CT imaging in the staging of biochemically recurrent prostate cancer,” was accepted by The Journal of Urology and is now available online. The manuscript will also appear in an upcoming print issue. Lead authors are T. Bach-Gansmo of Oslo University, Oslo, Norway; C. Nanni of the University of Bologna, Bologna, Italy and P.T. Nieh of Emory University, Atlanta, Ga.
Blue Earth Diagnostics CEO Jonathan Allis, D.Phil., said these study results, in combination with a second Phase 3 study, formed the basis for the Priority Review and approval of Axumin by the U.S. Food and Drug Administration (FDA).
“Axumin was designed and developed by Dr. Mark Goodman at Emory University to enable visualization with PET imaging of increased amino acid transport that occurs in many cancers,” said David M. Schuster, M.D., an investigator in the Axumin Phase 3 study and associate professor of radiology and imaging sciences and director of the Division of Nuclear Medicine and Molecular Imaging, Emory University. “While investigating this PET radiotracer we discovered its utility in detecting and localizing suspected biochemically recurrent prostate cancer. This study was designed to evaluate the diagnostic performance and safety of Axumin in this specific patient population.”
“Biochemically recurrent prostate cancer occurs in up to one-third of men who have been treated for prostate cancer, and is therefore a very important medical challenge,” said Judd Moul, M.D., professor of surgery, urology, at Duke University. “These patients are assumed to have disease present, and knowing the location and extent of suspected disease could profoundly impact patient management decisions. Effective detection and localization of recurrent disease is critical in order to select optimal management for these patients, yet the sensitivity of standard-of-care anatomical imaging tests is very limited for identifying sites of prostate cancer recurrence. In my opinion, information provided by Axumin PET imaging may provide information critical to developing effective patient management plans, with the potential to lead to better outcomes for men with recurrent prostate cancer.”
A total of 596 patients underwent Axumin PET/computed tomography (CT) imaging at four clinical sites in Norway, Italy and the United States to determine the detection rate (DR) stratified by PSA values. Additionally, the diagnostic performance of Axumin was assessed against histopathology (biopsy) in 143 scans. Results indicated a detection rate (DR) for Axumin of 68 percent (403/595 patients). In the prostate/bed and pelvic lymph node regions, positive findings were detected in 39 percent (232/599) and 33 percent (194/596) of scans, respectively. Metastatic involvement outside the pelvis was detected in 26 percent (155/591) of Axumin scans. The DR for Axumin in patients in the lowest quartile of baseline PSA (<0.79 ng/mL) was 41 percent (53/128 patients). Of these patients, 13 had involvement in the prostate/bed only, 16 had pelvic lymph node involvement without distant disease and 24 had distant metastases. For the 143 patient scans, the positive predictive value (PPV) of Axumin PET/CT scanning was 82 percent. For tumors in the prostate/prostate bed the PPV was 72 percent and for extraprostatic tumors it was 92 percent.
In this study population, adverse events were reported in 5.4 percent of patients, with none considered related to Axumin. The safety profile was not altered following repeat administration. The authors concluded that Axumin is well tolerated and able to detect local and distant prostate cancer recurrence across a wide range of PSA values.
For more information: www.blueearthdiagnostics.com