Lantheus Reveals Disappointing Clinical Trial Results for Ultrasound Contrast Agent

Lantheus Holdings Inc., parent company of Lantheus Medical Imaging Inc. (LMI), a developer, manufacturer, and commercializer of diagnostic imaging agents and products, has announced topline results for the BENEFIT 1 Left Ventricular Ejection Fraction (LVEF) clinical trial.
 
The BENEFIT 1 LVEF clinical trial is one of two Phase 3, open-label, multicenter studies to evaluate LVEF measurement accuracy and reproducibility of DEFINITY contrast-enhanced and unenhanced echocardiography as compared to non-contrast cardiac magnetic resonance imaging (CMRI) used as the truth standard. BENEFIT 1 enrolled 145 subjects. The primary objective of this study was to demonstrate improvement in accuracy in measuring LVEF using DEFINITY contrast-enhanced over unenhanced echocardiography as compared to LVEF measured using CMRI.
 
In BENEFIT 1, there was no statistically significant improvement in the accuracy of LVEF values for contrast-enhanced echocardiography versus unenhanced echocardiography as compared to CMRI. Analyses of the secondary endpoints revealed no improvement in inter-reader variability between the contrast-enhanced and unenhanced echocardiograms for LVEF assessments. A post-hoc analysis, however, did show statistically significant improvements in left ventricular diastolic, systolic and stroke volume measurements with contrast-enhanced versus unenhanced echocardiography when compared to CMRI.
 
“Although the endpoints for BENEFIT 1 were not met, we will continue to analyze the BENEFIT 1 data,” said Dr. Istvan Molnar, chief medical officer of Lantheus. “When the data from BENEFIT 2 are available, we will compile the data sets to analyze the full results of the trials. We are grateful to the patients, investigators, and trial sites for participating in this trial.”
 
“DEFINITY is the worldwide leading product in the ultrasound contrast market and it remains a proven and preferred imaging agent serving the echocardiography community within its current indication,” said Mary Anne Heino, president and CEO of Lantheus. “DEFINITY’s consistent year-over-year double digit percentage revenue growth demonstrates the value it continues to provide physicians in diagnosing and managing patients. We are disappointed with the outcome of the BENEFIT 1 trial but we remain fully confident in DEFINITY and the long term growth potential of our microbubble franchise. We will continue to interact with the FDA to enhance the clinical utility for DEFINITY moving forward.”
 
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms.¹ DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.¹ DEFINITY has extensive safety experience and a consistent safety profile.² Since its launch in 2001, more than 11 million echo studies have been performed with DEFINITY and it is the most prescribed contrast agent in the United States.³
 
References
¹ DEFINITY (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc., 2017.
² Data on file, Lantheus Medical Imaging, Inc.
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