Oncopeptides launches new real-world evidence study of Pepaxti in Spain, first patient enrolled
Oncopeptides AB today announces that the first patient has been enrolled in its new real-world evidence study, evaluating the use of Pepaxti in routine clinical settings across Spain.
The non-interventional study OP-115, named LAGOON, will include approximately 50 adult patients at approximately 20 participating sites. Its objective is to collect real-world clinical data on the effectiveness and safety of Pepaxti in patients with relapsed, refractory multiple myeloma (RRMM), reflecting the approved indication. This marks the first study of its kind for Pepaxti in Spain and is expected to generate important insights to support clinical decision-making and future market development.
“Beginning the LAGOON study with our first enrolled patient, from Hospital Universitario de Cabueñes in Asturias, is an important milestone in understanding how Pepaxti performs in real-world conditions,” says Enrique Ocio, Head of the Hematology Department at Marqués de Valdecilla University Hospital in Santander and principal investigator of the study. “We’re proud to contribute to the advancement of care for patients with RRMM through this collaboration with Oncopeptides.”
“This is a crucial step in building the real-world evidence base for Pepaxti,” says Sofia Heigis, CEO of Oncopeptides. “Spain represents an important market for Oncopeptides, and we are excited to work alongside clinicians to broaden our understanding of how Pepaxti benefits patients outside of the clinical trial setting.”
The results of the LAGOON study will support Oncopeptides’ efforts to provide relevant real-world data to healthcare providers, payers, and regulators across Europe.
In July 2024, Oncopeptides communicated the first patient in a similar real-world study in Germany, named HARBOUR.
Investor Q&A
What is the LAGOON study?
LAGOON (OP-115) is a non-interventional real-world evidence study initiated by Oncopeptides to evaluate the effectiveness and safety of Pepaxti in Spanish patients with relapsed, refractory multiple myeloma (RRMM). It reflects routine clinical use in a population aligned with the approved indication.
Why is this study important?
Real-world evidence complements clinical trial data by providing insights into how medicines perform in everyday healthcare settings. The LAGOON study is designed to support clinical decision-making and inform market access efforts by generating robust, locally relevant data from Spain.
How many patients will be included and where?
The study aims to enroll approximately 50 adult patients across ~20 clinical sites in Spain.
What outcomes are being assessed?
The study will observe clinical endpoints such as overall response rate, duration of response, overall survival, and safety profile, along with health-related quality of life indicators.
What is the study timeline?
Recruitment began in Q1 2025. Results will be analyzed and disseminated after completion of patient follow-up, in line with standard real-world data protocols.
How does this support Oncopeptides’ growth?
LAGOON strengthens Oncopeptides’ value proposition to healthcare providers and payers by generating local evidence in a commercial setting, which can support reimbursement discussions and physician engagement.
Will the results be made public?
Yes, Oncopeptides is committed to transparency. The data will be published in scientific journals or presented at conferences, and relevant updates will be shared on the company’s website.