Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F24%3A10475680" target="_blank" >RIV/00179906:_____/24:10475680 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/24:00136422 RIV/61988987:17110/24:A25039NF RIV/00216208:11110/24:10475680 RIV/00216208:11150/24:10475680 a 3 dalších

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=FqxxJcahQW" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=FqxxJcahQW</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3324/haematol.2023.283509" target="_blank" >10.3324/haematol.2023.283509</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study

Popis výsledku v původním jazyce

Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone was approved in Europe for use in patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) with &gt;=3 prior lines of therapy and without prior autologous stem cell transplantation (ASCT) or with a time to progression &gt;36 months after prior ASCT. The randomized LIGHTHOUSE study (NCT04649060) assessed melflufen plus daratumumab and dexamethasone (melflufen group) versus daratumumab in patients with RRMM with disease refractory to an immunomodulatory agent and a proteasome inhibitor or who had received &gt;=3 prior lines of therapy including an immunomodulatory agent and a proteasome inhibitor. A partial clinical hold issued by the US Food and Drug Administration for all melflufen studies led to financial constraints and premature study closure on February 23, 2022 (data cutoff date). In total, 54 of 240 planned patients were randomized (melflufen group, n=27; daratumumab group, n=27). Median progression-free survival (PFS) was not reached in the melflufen group versus 4.9 months in the daratumumab group (hazard ratio, 0.18 [95% confidence interval, 0.05-0.65]; P=0.0032) at a median follow-up time of 7.1 and 6.6 months, respectively. Overall response rate (ORR) was 59% in the melflufen group versus 30% in the daratumumab group (P=0.0300). The most common grade &gt;=3 treatment-emergent adverse events in the melflufen group versus daratumumab group were neutropenia (50% versus 12%), thrombocytopenia (50% versus 8%), and anemia (32% versus 19%). Melflufen plus daratumumab and dexamethasone demonstrated superior PFS and ORR versus daratumumab in RRMM and a safety profile comparable to previously published melflufen studies.

Název v anglickém jazyce

Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study

Popis výsledku anglicky

Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone was approved in Europe for use in patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) with &gt;=3 prior lines of therapy and without prior autologous stem cell transplantation (ASCT) or with a time to progression &gt;36 months after prior ASCT. The randomized LIGHTHOUSE study (NCT04649060) assessed melflufen plus daratumumab and dexamethasone (melflufen group) versus daratumumab in patients with RRMM with disease refractory to an immunomodulatory agent and a proteasome inhibitor or who had received &gt;=3 prior lines of therapy including an immunomodulatory agent and a proteasome inhibitor. A partial clinical hold issued by the US Food and Drug Administration for all melflufen studies led to financial constraints and premature study closure on February 23, 2022 (data cutoff date). In total, 54 of 240 planned patients were randomized (melflufen group, n=27; daratumumab group, n=27). Median progression-free survival (PFS) was not reached in the melflufen group versus 4.9 months in the daratumumab group (hazard ratio, 0.18 [95% confidence interval, 0.05-0.65]; P=0.0032) at a median follow-up time of 7.1 and 6.6 months, respectively. Overall response rate (ORR) was 59% in the melflufen group versus 30% in the daratumumab group (P=0.0300). The most common grade &gt;=3 treatment-emergent adverse events in the melflufen group versus daratumumab group were neutropenia (50% versus 12%), thrombocytopenia (50% versus 8%), and anemia (32% versus 19%). Melflufen plus daratumumab and dexamethasone demonstrated superior PFS and ORR versus daratumumab in RRMM and a safety profile comparable to previously published melflufen studies.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

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

Název periodika

Haematologica

ISSN

0390-6078

e-ISSN

1592-8721

Svazek periodika

109

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

IT - Italská republika

Počet stran výsledku

11

Strana od-do

895-905

Kód UT WoS článku

001182209400032

EID výsledku v databázi Scopus

2-s2.0-85186504971