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Concopeptides Stockholm , Sweden Press release May 25 , 2021 Phase 3 OCEAN study demonstrates that melflufen is at least as efficacious as pomalidomide , the most used medicine in relapsed refractory multiple myeloma ● According to the Independent Review Committee Assessment , melflufen was non - inferior to pomalidomide on the primary endpoint of Progression Free Survival ( PFS ) with a Hazard Ratio favoring melflufen of 0.817 and the median PFS for melflufen was 41 % higher than for pomalidomide According to the Investigator Assessment , melflufen was superior to pomalidomide on PFS with a Hazard ratio favoring melflufen of 0.790 and median PFS for melflufen was 42 % higher than for pomalidomide The Overall Response Rate ( ORR ) was 32.1 % for melflufen , compared to 26.5 % for pomalidomide Melflufen and pomalidomide had similar discontinuation rates for adverse events , and the safety profile of melflufen was in line with previous studies STOCKHOLM May 25 , 2021 Oncopeptides AB ( publ ) ( Nasdaq Stockholm : ONCO ) , a global biotech company focused on the development of therapies for difficult - to - treat hematological diseases , today announces positive topline results from the head - to - head phase 3 OCEAN study evaluating the efficacy and safety of melflufen ( INN melphalan flufenamide ) versus pomalidomide in patients with relapsed refractory multiple myeloma ( RRMM ) . The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world . The topline results will be presented at a webcast on May 25 , 2021 , at 11:00 ( CET ) , log in details is available below . " 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 AB . “ 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 " . The PFS , as assessed by the independent review committee , demonstrated a Hazard Ratio * favoring melflufen of 0.817 ( 95 % CI : 0.659-1.012 , p = 0.0640 ) for the primary endpoint and shows that melflufen is non - inferior to pom domide . The Hazard Ratio for PFS as per investigator assessment was 0.790 ( 95 % CI : 0.639-0.976 ) . In both assessments , the median PFS for the melflufen arm was more than 40 % higher than for the pomalidomide arm . The Overall Response Rate for melflufen was 32.1 % vs. 26.5 % for pomalidomide . " The efficacy and safety data from the OCEAN study are very encouraging , and the results will be of importance in physicians ' treatment decisions for patients with relapsed and refractory multiple myeloma ” , says Pieter Sonneveld , MD , PhD , Professor of Hematology at the Erasmus University of Rotterdam , and Principal Investigator of the OCEAN study . " Melflufen has a unique mode of action , which in addition with its tolerability profile , makes the drug an attractive treatment option for many patients . "