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Concopeptides Stockholm , Sweden Pressrelease September 11 , 2021 Oncopeptides presents phase 3 OCEAN study results at the IMW meeting STOCKHOLM - September 11 , 2021 - Oncopeptides AB ( publ ) ( Nasdaq Stockholm : ONCO ) , a global biotech company focused on the development of therapies for difficult - to - treat hematological diseases , today presents data from the phase 3 OCEAN study , a direct head to head comparison of the efficacy and safety of melflufen ( INN melphalan flufenamide ) plus dexamethasone and pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma , ( RRMM ) , who are refractory to lenalidomide and have received 2-4 prior lines of therapy . The data was presented today by Fredrik Schjesvold , Head of Oslo Myeloma Center , Norway , at the 18th International Myeloma Workshop ( IMW ) in Vienna . Melflufen met the primary endpoint of superior Progression Free Survival ( PFS ) as assessed by the Independent Review Committee ( IRC ) , with a median PFS of 6.8 months , compared to 4.9 months for pomalidomide , a Hazard Ratio ( HR ) of 0.79 , and a p - value of 0.03 . The results of key secondary endpoints in the Intention to Treat ( ITT ) population were : Overall Survival ( OS ) , which favored pomalidomide with a HR of 1.10 , and Overall Response Rate ( ORR ) , where melflufen had a numerically higher ORR of 33 % compared to 27 % for pomalidomide . An extensive analysis of data in pre specified subgroups showed that the PFS benefit of melflufen mainly was driven by patients without a prior autologous stem cell transplant ( ASCT ) , with a median PFS of 9.3 months versus 4.6 months and a HR of 0.59 , compared to pomalidomide . The OS data in patients with no prior ASCT favored melflufen with a median OS of 21.6 months compared to 16.5 months for pomalidomide with a HR of 0.78 . However , the OS results in patients with a prior autologous stem cell transplant favored pomalidomide , with a median OS of 31.0 months versus 16.7 months for melflufen , and a HR of 1.61 . This benefit of pomalidomide over melflufen in the ASCT subgroup has contributed to the HR of 1.1 in the ITT population . Melflufen plus dexamethasone treatment resulted in substantially more grade 3/4 hematologic adverse events , when compared to pomalidomide . These were clinically managable and in line with previous reports but more dose modifications were needed with melflufen when compared to pomalidomide . On September 2 , the FDA announced a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee ( ODAC ) to occur on October 28 , 2021 , to discuss the safety findings including overall survival from the OCEAN study as a follow up to the FDA safety alert released on July 28 , 2021 . " The oral presentation of OCEAN study results at the IMW meeting represents an important milestone for Oncopeptides " , says Marty J Duvall , Chief Executive Officer at Oncopeptides . " We have confidence in the OCEAN data and are working closely with the FDA to address the regulatory situation for Pepaxto " . " The efficacy and safety data from the OCEAN study provide new and important insights for the multiple myeloma society " , says Pieter Sonneveld , MD , PhD , Professor of Hematology at the Erasmus University of Rotterdam , and Principal Investigator of the OCEAN study .