Lophius Biosciences GmbH, Regensburg, Germany, has announced top-line results from its multicenter AlloProtect CMV clinical study.1 Results of the study show the ability of Lophius’s CE-marked T-Track CMV test to transform treatment paradigms and patient management for inpatients receiving allogeneic hematopoietic stem cell transplantation, a procedure regularly performed to treat leukemia and lymphoma. The immune system monitoring assay opens up novel approaches to risk assessment and stratification—leading to better guidance for antiviral treatment decisions—due to its reliable identification of patients with freedom from recurrent treatment-requiring CMV reactivation.
Cytomegalovirus (CMV) is highly present in the human population, with an estimated seroprevalence of approximately 30% to 90%. In healthy individuals, CMV is efficiently controlled by the immune system, primarily via cell-mediated immunity. But in immunosuppressed patients such as transplant recipients, reactivation of CMV replication may require treatment with antiviral medication, either prophylactically during the first months after transplantation or preemptively based on CMV viral load measurement.
At present, the optimal duration of virological monitoring or antiviral therapy in response to CMV infection is not well defined. Moreover, assessment of CMV-specific immunity or the ability of immunosuppressed patients to control virus replication via their immune system, is typically not taken into consideration. By measuring CMV-specific cell-mediated immunity, T-Track CMV adds an additional dimension to anti-CMV treatment decisionmaking, complementing the currently used viral load tests and empowering clinicians in their decisions to start, discontinue, or adjust antiviral treatment.
“Following positive results in a kidney transplant setting last year, today’s results once more highlight the potential of our novel approach to assess the risk of CMV-related complications after transplantation,” says Bernd Merkl, CEO and managing director of Lophius Biosciences. “Applied broadly in clinical practice, our test could guide clinicians in their decision to start, discontinue, or adjust antiviral treatment, potentially avoiding unnecessary treatments and saving costs for the healthcare system.
“Beyond the positive results of T-Track CMV as such, today’s news once more underlines Lophius’s capabilities to successfully develop and establish novel diagnostic solutions, from inception to the market, handling complex clinical studies along the way,” adds Merkl. “This expertise is essential for our running core development program addressing an unmet clinical need in a new indication, tuberculosis, with a proprietary blood-based multimarker solution.”
In the prospective, longitudinal, observational, multicenter AlloProtect CMV study, 175 intermediate- and high-risk hematopoietic stem cell transplantation recipients were followed up to 7.5 months after transplantation for the occurrence of recurrent CMV reactivation. The primary goal was to evaluate whether T-Track CMV applied following a first treatment-requiring CMV reactivation after transplantation can predict freedom from recurrence of future CMV reactivation.
Study results showed that patients with a positive T-Track?CMV test result after resolution of the first CMV reactivation, as well as at 100 days after transplantation (when patients are usually discharged from the hospital), remained free from future recurrent CMV reactivation, with a specificity in diagnostic accuracy greater than 90%. Overall, the study demonstrated that T-Track CMV provides an improved risk stratification for CMV-related clinical complications, and can support clinicians in the identification of patients free from future recurrent CMV reactivation, thus improving the management of hematopoietic stem cell transplantation patients.
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- Clinical Validation of Lophius Biosciences Kit T-Track CMV in Allo-HSCT Recipients (AlloProtectCMV) [online]. Bethesda, Md: National Library of Medicine, 2018. Available at: https://clinicaltrials.gov/ct2/show/nct02156479?term=lophius&rank=3. Accessed February 11, 2019.