Figure showing an overview of the OCEAN study

The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.

The patients enrolled have previously been treated with at least an immunomodulatory agent (IMiD), and a proteasome inhibitor (PI). They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide (IMiD), the most used drug for the treatment of multiple myeloma.

The primary objective of the study was to compare progression free survival of melflufen+dexamethasone and pomalidomide+dexamethasone. Secondary objectives included response rates and overall survival.

The study started in Q2 2017 and included 495 patients in several countries across Europe, USA, South Korea and Taiwan. The last patient was enrolled in September 2020. OCEAN study continued with an additional 2-year long-term follow-up after the primary analysis and was completed in February 2023. Final long-term follow-up results was presented at the 65th American Society of Hematology meeting (ASH) in December 2023.