Bayer Reports Positive Results from ECR Late-Breaking Trial for Investigational MRI Contrast
Bayer announced positive results from the Phase III study QUANTI CNS, which evaluated the investigational gadolinium-based contrast agent (GBCA) gadoquatrane in adults with known or suspected pathologies of the central nervous system undergoing contrast-enhanced MRI. QUANTI CNS is part of Bayer’s pivotal QUANTI clinical development program consisting of two multinational Phase III studies in adults as well as a pediatric study. In all studies, gadoquatrane was investigated at a gadolinium dose of 0.04 mmol Gd/kg body weight which represents a gadolinium dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. The detailed results of QUANTI CNS were revealed as late-breaking clinical trial data at this year’s annual European Congress of Radiology (ECR).
“Contrast-enhanced magnetic resonance imaging is one of the most powerful diagnostic tools in contemporary clinical medicine, offering unparalleled insight into the human body,” said principal investigator Dr Benjamin P. Liu, Associate Professor of Radiology and Radiation Oncology, Northwestern University Feinberg School of Medicine. “A reduced gadolinium dose could be particularly valuable for patients suffering from central nervous system pathologies, as many of them undergo multiple MRI examinations along their diagnostic and treatment pathway and it is always advisable to administer the lowest efficacious dose of any drug. The results of the QUANTI CNS study highlight the potential of a reduced gadolinium dose demonstrating non-inferiority to the other comparator gadolinium-based contrast agents in the clinical trial. This has the potential to benefit both current and future generations of patients and healthcare professionals.”
Detailed study results of QUANTI CNS evaluating the efficacy and safety of gadoquatrane in adults with known or suspected pathologies of the central nervous system undergoing a contrast-enhanced MRI show that gadoquatrane met all primary and secondary study objectives. Non-inferior diagnostic efficacy to comparator macrocyclic GBCAs (gadobutrol, gadoterate meglumine/gadoteric acid, gadoteridol) dosed at 0.1 mmol Gd/kg body weight was demonstrated by a blinded central independent read using the three established visualization parameters – contrast enhancement, delineation, and morphology. Gadoquatrane also achieved non-inferior diagnostic performance to the trial comparators based on the sensitivity and specificity for the detection or exclusion of lesions. When compared to MRIs without contrast injection, gadoquatrane demonstrated superiority based on the visualization parameters. In total, QUANTI CNS included 305 patients from 16 countries in Europe, Asia, and America.
The safety events observed with gadoquatrane were similar to those observed for the comparator macrocyclic GBCAs with a low incidence of intervention related treatment emergent adverse events and generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs.
“The burden of neurological disorders impacts millions of patients around the world and is set to rise during the next decades,” said Dr Konstanze Diefenbach, Head of Radiology Research & Development, Bayer. “We are very pleased about the positive results shown in QUANTI CNS. We look forward to working with regulatory authorities worldwide, aiming to make gadoquatrane available for patients and their treating physicians as a new low dose option in contrast-enhanced MRI.”
In January 2025, Bayer announced positive topline data for the QUANTI study program, showing that gadoquatrane met the primary and main secondary endpoints of all studies. The results from QUANTI CNS were presented for the first time at ECR. The results of QUANTI OBR, which investigated the safety and efficacy of gadoquatrane in contrast-enhanced MRI of all other body regions, and QUANTI Pediatric assessing the pharmacokinetics and safety of gadoquatrane in children from birth to < 18 years of age are planned to be presented at upcoming scientific congresses. Bayer plans to submit a comprehensive data package which will include the study results to health authorities worldwide to secure marketing authorization for gadoquatrane.