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 immunomodulator 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 endpoint of the phase 3 study is Progression Free Survival (PFS). The results will be evaluated once 339 patients have progressed in their disease.
The study started in Q2 2017. In May 2020, the initial enrollment target of 450 patients were reached. A decision was made to continue recruitment up to 495 patients. The last patient was enrolled in September 2020. Top results from OCEAN were presented in May 2021. In conjunction with the presentation of the final PFS results Overall Survival data from the ITT-population was disclosed. Based on a HR of 1.104 favoring pomalidomide, the FDA requested a partial clinical hold, pending further investigation. On July 28, the FDA issued a safety alert to patients and health care professionals regarding an increased risk of death associated with Pepaxto® in the OCEAN study.