Mixed results from phase III flurpiridaz PET trial

Lantheus Medical Imaging has announced preliminary phase III clinical trial results for F-18 flurpiridaz as a diagnostic PET agent for myocardial perfusion imaging indicating high sensitivity but potentially lagging specificity for the detection of CAD.

F-18 flurpiridaz PET myocardial perfusion imaging was shown to be superior in sensitivity to SPECT when compared to the standard invasive coronary angiography. The phase III clinical trial was an open-label, multi-center study focusing on two distinct endpoints of sensitivity and specificity. F-18 flurpiridaz did not perform as strongly for ruling out disease.

“While preliminary results of this trial show that F-18 flurpiridaz missed one of the two co-primary endpoints, when looking at key secondary endpoints, such as image quality and diagnostic certainty, the image quality seen with F-18 flurpiridaz in the study is impressive, both absolutely and in comparison to SPECT, leading to a statistically significant improvement in diagnostic certainty,” stated Cesare Orlandi, MD, chief medical officer for Lantheus, in the release. “Image quality is very important in nuclear cardiology, since it allows diagnosing presence or absence of disease with greater confidence, which may lead to a decreased need for patient re-testing.”

Lantheus President and CEO Jeff Bailey added that additional steps are being planned to continue image and data analysis and the company intends to meet with both clinical advisors and the FDA. “We will explore potential modifications to our clinical development plan and determine how we can use the results of this trial to advance the phase III program for this exciting diagnostic candidate.”

Phase II clinical trial results for F-18 flurpiridaz were published Jan. 29 in the Journal of the American College of Cardiology.