Oncopeptides presents phase 3 OCEAN study results at the IMW meeting
STOCKHOLM, Sept. 11, 2021 /PRNewswire/ -- 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.
"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, Oslo, Norway. "These patients represent a highly underserved population".
For more information, please contact:
Linda Holmström, Director of Investor Relations, Oncopeptides AB (publ)
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About phase 3 OCEAN study
About melphalan flufenamide
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.
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