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
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
"The oral presentation of OCEAN study results at the IMW meeting represents an important milestone for
"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
"Results from the OCEAN study suggests that melflufen plus dexamethasone may become a potential treatment for patients with lenalidomide-refractory RRMM who have received 2-4 previous lines of therapy and who have not received a prior autologous stem cell transplant, says Fredrik Schjesvold, Head of Oslo Myeloma Center,
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E-mail: rolf.gulliksen@oncopeptides.com
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About phase 3 OCEAN study
The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies. The patients have previously all been treated with at least an immunomodulator agent (IMiD), and a proteasome inhibitor (PI). They have developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide. The study was initiated in 2017 and includes 495 patients from more than 100 hospitals around the world. The primary efficacy endpoint was superior PFS as measured by the IRC.
About
About melphalan flufenamide
Melphalan flufenamide, also known as melflufen, is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agents inside cancer cells. Aminopeptidases are overexpressed in multiple myeloma cells and are associated with advanced disease and tumor mutational burden. Targeting aminopeptidases causes selective activity in cancer cells, sparing healthy cells.
In the US, Pepaxto® (melphalan flufenamide) is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
https://news.cision.com/oncopeptides-ab/r/oncopeptides-presents-phase-3-ocean-study-results-at-the-imw-meeting,c3413441
https://mb.cision.com/Main/15404/3413441/1466947.pdf
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