Oncopeptides has announced updated results and safety measures based on the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma who have received 2 – 4 prior lines of therapy.
The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The results were announced on May 25th.
Updated OCEAN results
The updated OCEAN results follow a blinded reassessment by the Independent Review Committee (IRC). During the preparations of the clinical study report and regulatory documents it became apparent that the IRC was not provided with all the information available in the clinical database during the time of their initial assessment. This led to a thorough investigation of all 495 patients where a comparison was made between the data provided to the IRC and what data was available in the clinical database. Consequently, data from 29 patients had to be reassessed. 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.
“During the preparations of the clinical study report and regulatory documents it became apparent that the IRC was not provided with all the information available in the clinical database during the time of their initial assessment. This led to a thorough investigation of all 495 patients where a comparison was made between the data provided to the IRC and what data was available in the clinical database.”
Overall Survival (OS) was a key secondary endpoint in the OCEAN study. The OS HR was 1.104 in favor of pomalidomide for the Intention to Treat population. Oncopeptides has performed analyses of the OS data and the company believes that the OS results are primarily explained by substantial HR differences between pre-specified subgroups in both directions.
“Based on the observed large differences in overall survival in pre-specified subgroups, the FDA has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation.”
Based on the observed large differences in overall survival in pre-specified subgroups, the FDA has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation. Oncopeptides will co-operate closely with the FDA to expeditiously perform necessary analysis to fully understand the benefit/risk profile of melflufen and to identify what patients do benefit from treatment with melflufen in earlier lines of therapy in relapsed refractory multiple myeloma.
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