Oncopeptides AB (publ), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, announces that data from the phase 3 OCEAN study has been accepted as an oral presentation at the upcoming 18th International Myeloma Workshop (IMW), and the abstract is now available online. More comprehensive data will be presented at the IMW-meeting in Vienna on September 11, at 10:00 (CET).
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The phase 3 OCEAN study is a head-to-head comparison evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone. Melflufen met its primary endpoint and demonstrated superior Progression Free Survival (PFS) as assessed by the Independent Review Committee (IRC) versus pomalidomide, in patients with relapsed refractory multiple myeloma (RRMM) who are refractory to lenalidomide and have received 2-4 prior lines of therapy, with a Hazard Ratio* (HR) of 0.79, and p-value of 0.03. Overall Survival (OS) was a key secondary endpoint. The HR for OS was 1.10 in favor of pomalidomide in the Intention to Treat (ITT) population. An analysis of factors impacting overall survival is ongoing.
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“I am very pleased that the IMW has accepted our late breaker abstract on the OCEAN study, and I am looking forward to get our data presented to leading multiple myeloma experts”, says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer at Oncopeptides.
At the IMW Oncopeptides will also present data from the phase 2 PORT study, an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with RRMM. The study demonstrates that exposure to melphalan is similar after periferal and central intravenous administration, and that the differences in administration has no clinical consequences.
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