A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab
Jazyk angličtina Země Spojené státy americké Médium electronic
Typ dokumentu klinické zkoušky, fáze II, dopisy, práce podpořená grantem
Grantová podpora
P30 CA014236
NCI NIH HHS - United States
PubMed
33980831
PubMed Central
PMC8116334
DOI
10.1038/s41408-021-00478-4
PII: 10.1038/s41408-021-00478-4
Knihovny.cz E-zdroje
- MeSH
- chemorezistence MeSH
- humanizované monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom farmakoterapie MeSH
- monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- protinádorové látky imunologicky aktivní škodlivé účinky terapeutické užití MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- dopisy MeSH
- klinické zkoušky, fáze II MeSH
- práce podpořená grantem MeSH
- Názvy látek
- daratumumab MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- isatuximab MeSH Prohlížeč
- monoklonální protilátky MeSH
- protinádorové látky imunologicky aktivní MeSH
CHU and CIC Inserm1402 Poitiers France
CHU de Toulouse IUCT O Université de Toulouse UPS Service d'hématologie Toulouse France
Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic
Department of Oncology Karmanos Cancer Institute Wayne State University Detroit MI USA
Division of Medical Oncology Washington University St Louis MO USA
Duke Cancer Institute Duke University Durham NC USA
Gabrail Cancer Center Canton OH USA
Hematology Department Nantes University Hospital Nantes France
Sanofi Clinical Sciences and Operations Beijing China
Sanofi Global Oncology Cambridge MA USA
Sanofi Translational Medicine and Early Development Paris France
Service d'hématologie CHRU Hôpitaux de Brabois Nancy France
Takeda Pharmaceuticals Cambridge MA USA
Translational Genomics Research Institute City of Hope Cancer Center Phoenix AZ USA
Unité Hémopathies Lymphoïdes CHU Henri Mondor Créteil France
Zobrazit více v PubMed
Deckert J, et al. SAR650984, a novel humanized CD38-targeting antibody, demonstrates potent antitumor activity in models of multiple myeloma and other CD38+ hematologic malignancies. Clin. Cancer Res. 2014;20:4574–4583. doi: 10.1158/1078-0432.CCR-14-0695. PubMed DOI
Jiang H, et al. SAR650984 directly induces multiple myeloma cell death via lysosomal-associated and apoptotic pathways, which is further enhanced by pomalidomide. Leukemia. 2016;30:399–408. doi: 10.1038/leu.2015.240. PubMed DOI
van Bueren L, et al. Direct in vitro comparison of daratumumab with surrogate analogs of CD38 antibodies MOR03087, SAR650984 and Ab79. Blood. 2014;124:3474. doi: 10.1182/blood.V124.21.3474.3474. DOI
Martin, T. G. et al. Therapeutic opportunities with pharmacological inhibition of CD38 with isatuximab. Cells8, 1522 (2019). PubMed PMC
Sarclisa® (isatuximab-irfc) [package insert]. (Sanofi-Aventis U.S. LLC, 2020).
Sanofi. European Commission approves Sarclisa® (isatuximab) for adults with relapsed and refractory multiple myeloma. (2020). (Accessed 12 June 2020). https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/media-room/press-releases/2020/2020-06-02-12-47-38-2042068-en.pdf.
Sanofi Japan Press Release June 29. Sarclisa®100 mg/500 mg IV infusion approved for relapsed or refractory myeloma. (2020). (Accessed 23 July 2020). https://www.sanofi.co.jp/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-JP/Home/press-releases/PDF/2020/200629-02.pdf?la=ja.
Mikhael J. A dose-finding phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma. Leukemia. 2020;34:3298–3309. doi: 10.1038/s41375-020-0857-2. PubMed DOI PMC
Martin T, et al. Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma. Blood Cancer J. 2019;9:41. doi: 10.1038/s41408-019-0198-4. PubMed DOI PMC
Usmani, S. Z. et al. Isatuximab short-duration fixed-volume infusion combination therapy for relapsed/refractory multiple myeloma: final results of a phase 1b feasibility/safety study. Presented at the European Hematology Association Congress (EHA 25), Virtual, June 11–21 (2020).
Becnel MR, et al. Descriptive analysis of isatuximab use following prior daratumumab in patients with relapsed/refractory multiple myeloma. Blood. 2020;136:20–21. doi: 10.1182/blood-2020-140526. DOI
Nooka AK, et al. Clinical efficacy of daratumumab, pomalidomide and dexamethasone in relapsed, refractory myeloma patients: utility of retreatment with daratumumab among refractory patients. Cancer. 2019;125:2991–3000. doi: 10.1002/cncr.32178. PubMed DOI
ClinicalTrials.gov
NCT02283775, NCT02514668
