Phase 3 OCEAN study demonstrates that melphalan flufenamide is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma

Excerpt from the Press Release:

Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melphalan flufenamide versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world.

“Following the accelerated approval of Pepaxto^® in the U.S. earlier this year, the positive topline results from the OCEAN study marks another major milestone for Oncopeptides. It is very exciting news for patients and indicates that melphalan flufenamide has the potential to become part of the standard of care in relapsed refractory multiple myeloma”, says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. “By demonstrating that melphalan flufenamide is at least as efficacious as pomalidomide, we are now able to begin the preparation of a sNDA which could pave the way for a potential use of melphalan flufenamide in earlier lines of therapy in a substantially larger patient population.”

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