Oncopeptides have announced positive results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen versus pomalidomide in patients with relapsed refractory multiple myeloma.
The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world.
“By demonstrating that melflufen is at least as efficacious as pomalidomide, we pave the way for a potential use of melflufen in earlier lines of therapy in a substantially larger patient population.”
“Following the accelerated approval of Pepaxto in the U.S. earlier this year, the positive topline results from the OCEAN study marks another major milestone for Oncopeptides. It is very exciting news for patients and indicates that melflufen has the potential to become part of the standard of care in relapsed refractory multiple myeloma”, says Marty J Duvall, Chief Executive Officer at Oncopeptides. “By demonstrating that melflufen is at least as efficacious as pomalidomide, we pave the way for a potential use of melflufen in earlier lines of therapy in a substantially larger patient population.”
Head-to-head-comparison
Melflufen and pomalidomide had similar discontinuation rates for adverse events, and the safety profile of melflufen was in line with previous studies and consistent across age subgroups.
“This head-to-head-comparison was a bold study with an optimal design for demonstrating melflufen’s true isolated treatment effects.”
“The outcome from the phase 3 OCEAN study is very good news for patients with relapsed refractory multiple myeloma,” says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer at Oncopeptides. “This head-to-head-comparison was a bold study with an optimal design for demonstrating melflufen’s true isolated treatment effects. I am truly looking forward to sharing these data with a broader audience, as the OCEAN data clearly show that melflufen may be an important therapeutic option for the increasing number of patients who need more treatment alternatives.”
Based on these data, Oncopeptides intends to submit a supplementary New Drug Application to the US Food and Drug Administration FDA, in Q4 2021.
Photo of Klaas Bakker, CMO, Oncopeptides
