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Benefit versus risk assessment of melflufen and dexamethasone in relapsed/refractory multiple myeloma: analyses from longer follow-up of the OCEAN and HORIZON studies

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F23%3AE0110356" target="_blank" >RIV/00843989:_____/23:E0110356 - isvavai.cz</a>

  • Alternative codes found

    RIV/61988987:17110/23:A2402NCC

  • Result on the web

    <a href="https://www.sciencedirect.com/science/article/pii/S2152265023001441?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2152265023001441?via%3Dihub</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/j.clml.2023.05.004" target="_blank" >10.1016/j.clml.2023.05.004</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Benefit versus risk assessment of melflufen and dexamethasone in relapsed/refractory multiple myeloma: analyses from longer follow-up of the OCEAN and HORIZON studies

  • Original language description

    Introduction: Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS) but directionally different overall survival (OS) favoring pomalidomide (hazard ratio [HR], 1.10) in OCEAN. Methods: These analyses further investigated prognostic subgroups impacting survival in updated data from the randomized, phase 3 OCEAN study (NCT03151811; date: February 3, 2022) and the phase 2 HORIZON study (NCT02963493; date: February 2, 2022). Results: In OCEAN, subgroups prognostic for OS were age (P = .011; <65 years favored pomalidomide) and no previous autologous stem cell transplant (ASCT) or progression >36 months after ASCT (P = .001; favored melflufen). Overall, 245 of 495 (49%) patients randomized had received a previous ASCT, of which 202 (82%) had progressed within 36 months following their ASCT. When excluding patients who had progressed <36 months post-ASCT (melflufen group, n = 145; pomalidomide group, n = 148), median OS was 23.6 months with melflufen and 19.8 months with pomalidomide (HR, 0.83 [95% CI, 0.62-1.12]; P = .22). Among patients with triple-class refractory disease in HORIZON, patients who had progressed <36 months post-ASCT (n = 58) had a lower response rate and shorter duration of response and PFS than the remaining patients (n = 52). Safety was consistent with previous reports. Conclusion: These analyses demonstrate a consistent benefit for melflufen and dexamethasone in patients with relapsed/refractory multiple myeloma who have not received an ASCT or progressed >36 months after receiving an ASCT (ClinicalTrials.gov identifier: NCT03151811).

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30205 - Hematology

Result continuities

  • Project

  • Continuities

    V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Others

  • Publication year

    2023

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Clinical Lymphoma, Myeloma & Leukemia

  • ISSN

    2152-2650

  • e-ISSN

    2152-2669

  • Volume of the periodical

    23

  • Issue of the periodical within the volume

    9

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    10

  • Pages from-to

    687-696

  • UT code for WoS article

    001141294100001

  • EID of the result in the Scopus database

    2-s2.0-85164122508