First patient enters real-world data study in Germany
Oncopeptides recently announced entry of the first patient in a new study evaluating the real-world effectiveness and safety of Pepaxti in German patients. The study, which will include 100 patients across around 50 sites in Germany, aims at gathering evidence on Pepaxti’s effectiveness and safety in a real-world clinical practice and is the first Pepaxti study engaging treating physicians at multiple German sites.
The study, named HARBOUR, will assess real-life clinical outcomes of Pepaxti treatment of patients suffering from refractory, relapsed multiple myeloma (RRMM) in a patient population that mirrors the indication of Pepaxti. The study marks another step forward in Oncopeptides’ ongoing efforts to strengthen the medical understanding of Pepaxti and will support the evidence base for the Pepaxti indicated population.
“Initiating the HARBOUR study with the enrollment of the first patient is a pivotal step forward to address the unmet needs of RRMM patients,” says Dr. med. Johannes Waldschmidt, the Scientific Leader of the study from Universitätsklinikum Würzburg, Germany. “This partnership with Oncopeptides offers an opportunity for the German medical community to contribute to significant advancements in myeloma treatment and patient care.”
“Our aim is to understand the performance of Pepaxti in the real world. It is important evidence to generate, not only for the German market but for the full European commercialization,” says Sofia Heigis, CEO of Oncopeptides. “We are happy to for the first time initiate a study across Germany and also the very first study that is fully focused on our target population.”
For more information, please visit the German Clinical Trials Register or read the questions and answers below.
Questions and answers for investors
What is this?
Oncopeptides has announced that they have successfully enrolled the first patient in the OP-113 study named HARBOUR, aiming to gain further insights on the effectiveness and safety of melflufen (Pepaxti) in combination with dexamethasone for relapsed, refractory multiple myeloma (RRMM) patients.
What implications does this study have for shareholders?
This study represents a strategic investment in our product’s future and market expansion, aiming to enhance shareholder value through confirmed patient outcomes in real life.
How does this development affect the company´s relationship with healthcare professionals in Germany?
The study will highlight Oncopeptides’ growing presence and strengthens our collaboration with German healthcare professionals, fostering trust and opening avenues for future partnerships in clinical research.
How many patients do you plan to enroll, and over what timeframe?
We aim to enroll 100 adult patients across approximately 50 sites in Germany. The recruitment phase is scheduled for 24 months.
What makes the HARBOUR study design unique?
This non-interventional study is designed to observe Pepaxti’s effectiveness and safety under real-life clinical settings, providing valuable insights that go beyond controlled clinical trial environments.
What outcomes are you hoping to achieve with the study?
It aims to validate Pepaxti’s effectiveness in overall response rates, duration of response, and overall survival in RRMM patients, alongside assessing its safety profile and impact on patients’ quality of life.
How does Oncopeptides support patients during the study?
Patient safety and wellbeing are top priorities. Oncopeptides strives to ensure rigorous monitoring of health outcomes and adverse events, providing support needed through every step of the treatment journey.
How does this study contribute to the scientific community’s understanding of RRMM?
By evaluating Pepaxti in a real-world setting, we’re generating valuable data in our indicated population that could refine treatment strategies, offering new insights into managing a challenging condition with a high unmet medical need.
Will the results of the study be made public?
Yes, we are committed to transparency and plan to disseminate the study results through scientific publications and presentations, ensuring the broader medical and patient communities benefit from our findings.
How does this study affect net sales in Germany?
The study is being conducted on regular patients.