Melflufen in relapsed/refractory multiple myeloma refractory to prior alkylators: A subgroup analysis from the OCEAN study

Fredrik H. Schjesvold*, Heinz Ludwig, Maria Victoria Mateos, Alessandra Larocca, Haifaa Abdulhaq, Stefan Norin, Marcus Thuresson, Nicolaas A. Bakker, Paul G. Richardson, Pieter Sonneveld

*Corresponding author for this work

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Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS), but not overall survival (OS), versus pomalidomide plus dexamethasone in relapsed/refractory multiple myeloma in the OCEAN study. Time to progression (TTP) <36 months after a prior autologous stem cell transplantation (ASCT) was a negative prognostic factor for OS with melflufen. This post hoc exploratory analysis evaluated patients refractory to prior alkylators (e.g., cyclophosphamide and melphalan) in OCEAN. In 153 patients refractory to prior alkylators (melflufen, n = 78; pomalidomide, n = 75), the melflufen and pomalidomide arms had similar median PFS (5.6 months [95% CI, 4.2–8.3] vs. 4.7 months [95% CI, 3.1–7.3]; hazard ratio [HR], 0.92 [95% CI, 0.63–1.33]) and OS (23.4 months [95% CI, 14.4–31.7] vs. 20.0 months [95% CI, 12.0–28.7]; HR, 0.92 [95% CI, 0.62–1.38]). Among alkylator-refractory patients with a TTP ≥ 36 months after a prior ASCT or no prior ASCT (melflufen, n = 54; pomalidomide, n = 53), the observed median PFS and OS were longer in the melflufen arm than the pomalidomide arm. The safety profile of melflufen was consistent with previous reports. These results suggest that melflufen is safe and effective in patients with alkylator-refractory disease, suggesting differentiated activity from other alkylators.

Original languageEnglish
Pages (from-to)402-411
Number of pages10
JournalEuropean Journal of Haematology
Issue number3
Early online date15 Nov 2023
Publication statusPublished - Mar 2024

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© 2023 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.


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