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
The result's identifiers
Result code in 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>
Alternative codes found
RIV/61988987:17110/24:A25039NC RIV/00216208:11110/24:10483261 RIV/00843989:_____/24:E0111106 RIV/00064165:_____/24:10483261
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
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
Original language description
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<middle dot>5 mg/kg. Most common treatment-emergent adverse events were infusion-related reactions in 70<middle dot>3% (26/37) patients. Grade >= 3 thrombocytopenia was reported in 48<middle dot>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<middle dot>62 (95%CI: 2<middle dot>858; not calculable) months and 2<middle dot>79 (95%CI: 1<middle dot>150; 4<middle dot>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.
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
30205 - Hematology
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Journal of Haematology
ISSN
0902-4441
e-ISSN
1600-0609
Volume of the periodical
113
Issue of the periodical within the volume
5
Country of publishing house
US - UNITED STATES
Number of pages
13
Pages from-to
593-605
UT code for WoS article
001270208000001
EID of the result in the Scopus database
2-s2.0-85198392237