Gadoquatrane Excels in Phase III Trials

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. In total, 808 patients in 15 countries were included in the program.

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. QUANTI CNS evaluated the efficacy and safety of gadoquatrane in adults with known or highly suspected pathologies of the central nervous system undergoing a contrast-enhanced MRI. In common CNS disorders, such as brain tumors, brain metastasis and multiple sclerosis, MRI plays a key role in diagnosis and treatment decisions.  QUANTI OBR investigated the safety and efficacy of gadoquatrane in contrast-enhanced MRI of all other body regions, including head and neck, thorax including the breast and the heart, abdomen, pelvis, and extremities, as well as blood vessels with magnetic resonance angiography (MRA).  Topline results show that gadoquatrane met the primary and main secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection.   QUANTI Pediatric assessed the pharmacokinetics and safety of gadoquatrane in children from birth to < 18 years of age undergoing contrast-enhanced MRI. Results demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults.

“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.”

Bayer plans to submit a comprehensive data package which will include the QUANTI study results to health authorities worldwide to secure marketing authorization.