First Patient Enrolled in Oncopeptides’ Real-World Evidence Study Marina in Germany

Oncopeptides AB, a biotech company specializing in difficult-to-treat cancers, today announces that the first patient has been enrolled in the new real-world evidence study in Germany, named Marina. The study, conducted by iOMEDICO, evaluates the use of Pepaxti (melflufen) in combination with dexamethasone for patients with relapsed, refractory multiple myeloma (RRMM), in routine clinical settings.

Marina is an investigator-initiated, prospective, non-interventional study (NIS) designed to include 50 adult patients across approximately 25 clinical sites in Germany. The study population focuses on patients with relapsed, refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, directly reflecting the approved European indication of the medicine.

By tracking outcomes within everyday healthcare settings, the Marina study aims to bridge the gap between controlled clinical trials and routine clinical practice. It provides a sophisticated approach to capturing the practical nuances of modern myeloma management in the real world, including critical parameters such as Disease Control Rate (DCR) and Pepaxti’s role as a bridging and sequencing option to immunotherapies like CAR-T cells and bispecific antibodies.

The initiation and first enrollment of the study align with the previously communicated timeline for the second quarter of 2026. The trial is operationally supported by the innovative SYNERGY platform, which utilizes an agile recruitment model that activates participating centers "just-in-time" once an eligible patient has been identified. Oncopeptides provides financial support for the study, while iOMEDICO serves as the formal sponsor and coordinator.

The results of the Marina study will generate essential data to further strengthen the European real-world evidence base for Pepaxti, supporting continuous engagement with healthcare providers, clinical prescribers, and regulatory bodies.