Fredrik Schjesvold, MD, PhD, discusses key takeaways from the phase 3 OCEAN trial that was done in patients with relapsed/refractory multiple myeloma.
Fredrik Schjesvold, MD, PhD, founder and leader, Oslo Myeloma Center at Oslo University Hospital, member, International Myeloma Working Group, International Myeloma Society, European Hematology Association, and American Society of Hematology, discusses key takeaways from the phase 3 OCEAN trial (NCT03151811) that was done in patients with relapsed/refractory multiple myeloma.
The study, which examined melphalan flufenamide (Pepaxto; melflufen) plus dexamethasone vs pomalidomide plus dexamethasone in patients with relapsed/refractory myeloma who were refractory to lenalidomide (Revlimid), showed that melflufen increased progression-free survival by 3 months, according to Schjesvold.
Notably, pomalidomide/dexamethasone showed a non-statistically significant improvement in survival, with a hazard ratio of 1.1, which led to the FDA pausing enrollment to studies evaluating melflufen until more data could be collected, Schjesvold adds. The study showed that melflufen and pomalidomide did not provide benefit to the same subsets of patients. Specifically, those who had not undergone transplant, or who had received it long ago, derived a clear benefit from melflufen, Schjesvold explains.
As such, melflufen/dexamethasone seems to be most beneficial for patients who have not been treated with transplant, whereas patients who have received a recent transplant derive better outcomes from pomalidomide/dexamethasone, Schjesvold concludes.