An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F24%3A00080272" target="_blank" >RIV/65269705:_____/24:00080272 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61988987:17110/24:A25039NC RIV/00216208:11110/24:10483261 RIV/00843989:_____/24:E0111106 RIV/00064165:_____/24:10483261

Výsledek na webu

<a href="https://onlinelibrary.wiley.com/doi/10.1111/ejh.14270" target="_blank" >https://onlinelibrary.wiley.com/doi/10.1111/ejh.14270</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/ejh.14270" target="_blank" >10.1111/ejh.14270</a>

Jazyk výsledku

angličtina

Název v původním jazyce

An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma

Popis výsledku v původním jazyce

Objectives: Cluster of differentiation 38 (CD38) is a key target on multiple myeloma (MM) cells. This multi-centre, Phase 1, single-agent study (NCT04000282) investigated SAR442085, a novel fragment crystallisable (Fc)-modified anti-CD38 monoclonal antibody (mAb), with enhanced affinity towards Fc-gamma receptor on effector cells in patients with relapsed and/or refractory (RR) MM. Methods: This study comprised two parts: Part-A (dose-escalation involving anti-CD38 mAb pre-treated and naive patients) and Part-B (dose expansion). Primary endpoints were maximum tolerated dose and recommended Phase 2 dose (RP2D). Results: Thirty-seven heavily pre-treated patients were treated in Part A. Part-B (dose-expansion) was not studied. Seven dose-limiting toxicities were reported at DL3, DL5, DL6, and DL7. RP2D was determined to be 5-7&lt;middle dot&gt;5 mg/kg. Most common treatment-emergent adverse events were infusion-related reactions in 70&lt;middle dot&gt;3% (26/37) patients. Grade &gt;= 3 thrombocytopenia was reported in 48&lt;middle dot&gt;6% (18/37). Overall response rate was 70% in anti-CD38 mAb naive and 4% in anti-CD38 pre-treated patients, with a median progression-free survival of 7&lt;middle dot&gt;62 (95%CI: 2&lt;middle dot&gt;858; not calculable) months and 2&lt;middle dot&gt;79 (95%CI: 1&lt;middle dot&gt;150; 4&lt;middle dot&gt;172) months and, respectively. Conclusions: The efficacy of SAR442085 was promising in anti-CD38 mAb naive patients but did not extend to the larger cohort of anti-CD38 mAb pre-treated patients. This observation, along with transient high-grade thrombocytopenia, could potentially limit its clinical use.

Název v anglickém jazyce

An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma

Popis výsledku anglicky

Objectives: Cluster of differentiation 38 (CD38) is a key target on multiple myeloma (MM) cells. This multi-centre, Phase 1, single-agent study (NCT04000282) investigated SAR442085, a novel fragment crystallisable (Fc)-modified anti-CD38 monoclonal antibody (mAb), with enhanced affinity towards Fc-gamma receptor on effector cells in patients with relapsed and/or refractory (RR) MM. Methods: This study comprised two parts: Part-A (dose-escalation involving anti-CD38 mAb pre-treated and naive patients) and Part-B (dose expansion). Primary endpoints were maximum tolerated dose and recommended Phase 2 dose (RP2D). Results: Thirty-seven heavily pre-treated patients were treated in Part A. Part-B (dose-expansion) was not studied. Seven dose-limiting toxicities were reported at DL3, DL5, DL6, and DL7. RP2D was determined to be 5-7&lt;middle dot&gt;5 mg/kg. Most common treatment-emergent adverse events were infusion-related reactions in 70&lt;middle dot&gt;3% (26/37) patients. Grade &gt;= 3 thrombocytopenia was reported in 48&lt;middle dot&gt;6% (18/37). Overall response rate was 70% in anti-CD38 mAb naive and 4% in anti-CD38 pre-treated patients, with a median progression-free survival of 7&lt;middle dot&gt;62 (95%CI: 2&lt;middle dot&gt;858; not calculable) months and 2&lt;middle dot&gt;79 (95%CI: 1&lt;middle dot&gt;150; 4&lt;middle dot&gt;172) months and, respectively. Conclusions: The efficacy of SAR442085 was promising in anti-CD38 mAb naive patients but did not extend to the larger cohort of anti-CD38 mAb pre-treated patients. This observation, along with transient high-grade thrombocytopenia, could potentially limit its clinical use.

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

European Journal of Haematology

ISSN

0902-4441

e-ISSN

1600-0609

Svazek periodika

113

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

13

Strana od-do

593-605

Kód UT WoS článku

001270208000001

EID výsledku v databázi Scopus

2-s2.0-85198392237