Jan. 10, 2025 – Bayer has announced positive topline results of the Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane, an investigational gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI).
All QUANTI studies investigated gadoquatrane 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. Gadoquatrane successfully met the primary and main secondary endpoints of all QUANTI studies.
The QUANTI clinical development program encompassed two multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions) in adult patients, as well as QUANTI Pediatric, a study investigating pharmacokinetics and safety in pediatric patients from birth to <18 years of age in all body regions.
In QUANTI CNS and QUANTI OBR, researchers investigated the ability to visualize and detect known or suspected disease on MRI scans using gadoquatrane (0.04 mmol Gd/kg body weight) compared to scans without contrast injection and compared to scans using macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. Topline results show that gadoquatrane met the primary and main secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults.
The observed safety profile in adults as well as pediatric patients from birth to <18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.
“Contrast-enhanced MRI is a key diagnostic tool and particularly important to help define the treatment pathway for patients potentially suffering from severe illnesses such as cancer, cardiovascular disease or CNS-related disorders,” said principal investigator Prof. Julian A. Luetkens, University Hospital Bonn, Germany. “The QUANTI clinical development program is a key step in exploring a reduced gadolinium dose for patients in clinical practice while demonstrating similar efficacy to the trial comparators. This is especially important for patients in need for repeat contrast-enhanced MRI examinations as well as vulnerable populations such as pediatric patients.”
“As a leader in radiology, we are committed to bringing forward innovations for the benefit of patients, including potential options to reduce the gadolinium dose”, said Dr. Konstanze Diefenbach, Head of Radiology Research & Development, Bayer. “We are very pleased with the positive topline results of the QUANTI studies and are looking forward to sharing the data with the scientific community.”
Bayer plans to submit a comprehensive data package which will include the QUANTI study results to health authorities worldwide to secure marketing authorization.
For more information, go to www.bayer.com.
July 09, 2024 
