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 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. In the final analysis melflufen met the primary endpoint of superior Progression Free Survival (PFS) compared to pomalidomide with a Hazard Ratio (HR) of 0.792 (95% CI 0.640-0.979, p-value 0.0311) as determined by the IRC. Overall Survival (OS) was a key secondary endpoint in the OCEAN study. The OS HR was 1.104 (0.846-1.441) in favor of pomalidomide for the Intention to Treat population.
Based on the 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.
OCEAN study will continue with long-term follow-up and documentation in accordance to previous plans.