Exceptional long-term responses from OCEAN and HORIZON trials: melflufen-dexamethasone as an expansion of treatment options for relapsed/refractory multiple myeloma in the era of new immunotherapies?
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F25%3A10504822" target="_blank" >RIV/00179906:_____/25:10504822 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11150/25:10504822
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=ulhNs7U6TK" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=ulhNs7U6TK</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s00432-025-06326-3" target="_blank" >10.1007/s00432-025-06326-3</a>
Alternative languages
Result language
angličtina
Original language name
Exceptional long-term responses from OCEAN and HORIZON trials: melflufen-dexamethasone as an expansion of treatment options for relapsed/refractory multiple myeloma in the era of new immunotherapies?
Original language description
Alkylating agents have represented the first effective drug class in multiple myeloma (MM) but, since the introduction of novel effective drugs, their use has progressively decreased and is currently relegated to autologous stem cell transplant (ASCT) and few other settings. Nevertheless, the combination of melflufen (a peptide-drug conjugate pro-drug of melphalan) and dexamethasone was approved by the U.S. Food & Drug Administration (FDA) for triple-class refractory (TCR) patients after >= 4 prior lines of therapy (LOT) following results of HORIZON clinical trial (NCT02963493). This combination was subsequently withdrawn as it was not associated with improved overall survival (OS) as compared to pomalidomide-dexamethasone (OCEAN clinical trial, NCT03151811). However, since a post-hoc analysis showed a benefit in OS for patients without prior ASCT or with a time to progression (TTP) > 36 months after ASCT, the European Medicines Agency (EMA) has approved melflufen-dexamethasone for TCR patients after >= 3 LOT, including specification that TTP must be >= 3 years in patients with prior ASCT. In this paper, we report three cases of patients receiving the combination melflufen-dexamethasone in the aforementioned clinical trials in three hematologic centers across Europe and achieving exceptionally long responses as compared to the overall enrolled populations, with good tolerability. Further, we discuss the potential use of this chemotherapy-based regimen in the era of novel immunotherapies.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Cancer Research and Clinical Oncology
ISSN
0171-5216
e-ISSN
1432-1335
Volume of the periodical
151
Issue of the periodical within the volume
11
Country of publishing house
DE - GERMANY
Number of pages
10
Pages from-to
288
UT code for WoS article
001591244900001
EID of the result in the Scopus database
2-s2.0-105018295641