Bayer's MRI contrast agent gadoquatrane succeeds in Phase III trials

Bayer, a renowned global entity in the field of radiology, has announced promising topline outcomes from the pivotal Phase III QUANTI studies. These studies were conducted to evaluate the effectiveness and safety of gadoquatrane, a novel gadolinium-based contrast agent (GBCA) intended for use in magnetic resonance imaging (MRI). Gadoquatrane was tested at a reduced gadolinium dose of 0.04 mmol Gd/kg body weight, marking a 60% decrease compared to the usual 0.1 mmol Gd/kg body weight used in macrocyclic GBCAs. Impressively, gadoquatrane met both the primary and key secondary endpoints in all QUANTI studies.

The QUANTI clinical development initiative comprised two significant multinational Phase III studies: QUANTI CNS (targeting the central nervous system) and QUANTI OBR (focusing on other body regions) in adult patients. Additionally, the QUANTI Pediatric study explored the pharmacokinetics and safety of gadoquatrane in pediatric patients aged from birth to under 18, encompassing all body regions.

In the QUANTI CNS and QUANTI OBR studies, researchers examined the capability of gadoquatrane to visualize and identify existing or potential diseases on MRI scans. This was compared with scans without contrast and those using macrocyclic GBCAs at the higher dose. The results indicated that gadoquatrane effectively met the primary and secondary efficacy endpoints related to imaging parameters and lesion detection. The QUANTI Pediatric study found that the pharmacokinetic properties of gadoquatrane in children aligned closely with those observed in adults.

The safety profile noted in both adult and pediatric groups in the QUANTI studies was consistent with previous data on gadoquatrane and other macrocyclic GBCAs, with no new safety concerns identified.

Professor Julian A. Luetkens from the University Hospital Bonn, Germany, a principal investigator, emphasized the importance of contrast-enhanced MRI in diagnosing serious ailments like cancer, cardiovascular afflictions, and CNS disorders. He highlighted the significance of the QUANTI program in exploring a reduced gadolinium dose for patients, proving its comparable efficacy to existing contrast agents. This reduction is particularly beneficial for patients requiring frequent MRI scans and vulnerable groups such as children.

Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer, expressed satisfaction with the positive results from the QUANTI studies and the potential to offer lower gadolinium doses. Bayer intends to present a comprehensive data package, including the QUANTI results, to health authorities globally to seek marketing authorization.

The Phase III QUANTI program incorporated two large, multicenter, randomized, prospective double-blind, cross-over studies: QUANTI CNS and QUANTI OBR. Additionally, the QUANTI Pediatric study was included. Altogether, the program involved 808 patients from 15 countries. QUANTI CNS focused on evaluating gadoquatrane's safety and efficacy in adults with suspected CNS issues undergoing MRI. MRI is crucial in diagnosing CNS disorders like brain tumors and multiple sclerosis. The QUANTI OBR study assessed gadoquatrane's performance in MRI of other body regions, including head, neck, thorax, abdomen, pelvis, and extremities, as well as blood vessels through magnetic resonance angiography.

The design and dosing strategy for this program were informed by positive results from a preceding Phase II study, which evaluated the efficacy and safety of gadoquatrane at the reduced dose. This earlier study was a multicenter, single-blind, adaptive dose-finding trial involving single intravenous injections of gadoquatrane in adult patients with suspected CNS lesions.

Gadoquatrane is Bayer's investigational extracellular macrocyclic contrast agent, designed with a unique tetrameric structure that offers high stability and relaxivity for contrast enhancement in MRI. Globally, around 65 million MRI procedures are conducted annually, playing a vital role in the healthcare continuum without involving radiation. MRI provides detailed body images, helping to detect and differentiate potential abnormalities, thus aiding physicians in addressing critical medical concerns regarding disease detection and monitoring.

Bayer, with over a century of experience in radiology, is dedicated to advancing patient care through innovative products and high-quality services. The company's radiology segment offers a robust portfolio, including contrast media for various imaging modalities, devices for precise administration, informatics solutions, and an AI-enabled medical imaging platform. In 2023, Bayer's radiology products generated approximately €2 billion in sales, underscoring its commitment to research and development in medical imaging innovation.