Oncopeptides – Annals of Hematology: Expert consensus supports use of Pepaxti in myeloma
Stockholm – November 11, 2025 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces that a panel of leading multiple myeloma experts has published clinical recommendations for the optimal use of melflufen (branded in Europe as Pepaxti) in Annals of Hematology. The review article provides practical guidance on patient selection, dosing, and management, reinforcing Pepaxti’s role as an important treatment option for patients with relapsed, refractory multiple myeloma (RRMM).
The expert group, led by Prof. Dr. Heinz Ludwig (Wilhelminen Cancer Research Institute, Vienna), assessed available clinical trial data together with real-world experience from European practice. Their consensus highlights that melflufen is a valuable treatment alternative for heavily pretreated patients, including elderly patients and those with high-risk disease, with a well-characterized and manageable safety profile.
“Based on both trial data and our clinical experience, we conclude that melflufen offers meaningful benefit to a broad spectrum of patients with relapsed or refractory myeloma, especially those with few remaining therapeutic options,” says Prof. Dr. Heinz Ludwig, lead author of the article. “Our recommendations aim to assist treating physicians in optimizing patient outcomes with melflufen in everyday clinical practice.”
“These expert recommendations add further weight to Pepaxti’s positioning as an effective therapy in later lines of treatment,” says Stefan Norin, Chief Medical Officer at Oncopeptides. “Importantly, they confirm the drug’s utility across different patient subgroups and align with the evidence base from both the pivotal HORIZON and OCEAN studies as well as real-world use.”
The article, “Optimizing the use of melflufen in relapsed or refractory multiple myeloma: Recommendations for clinical practice”, is available online in Annals of Hematology.
For more information, please visit oncopeptides.com, where you will also find a Q&A for investors.
For more information, please contact:
David Augustsson, Director of IR and Communications, Oncopeptides AB (publ)
E-mail: ir@oncopeptides.com
Cell phone: +46 76 229 38 68
About Oncopeptides
Oncopeptides is a Swedish biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers.
The company uses its proprietary Peptide Drug Conjugate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Its flagship drug is currently being commercialized in Europe with partnership agreements for South Korea, the Middle East and Africa and elsewhere.
Oncopeptides is also developing several new compounds based on its two proprietary technology platforms PDC and SPiKE.
The company was founded in 2000, has about 80 employees with operations in Sweden, Germany, Austria, Spain and Italy. Oncopeptides is listed on Nasdaq Stockholm with the ticker ONCO.
For more information see: www.oncopeptides.com
About Pepaxti
Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.