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A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab

. 2021 May 12 ; 11 (5) : 89. [epub] 20210512

Language English Country United States Media electronic

Document type Clinical Trial, Phase II, Letter, Research Support, Non-U.S. Gov't

Grant support
P30 CA014236 NCI NIH HHS - United States

Links

PubMed 33980831
PubMed Central PMC8116334
DOI 10.1038/s41408-021-00478-4
PII: 10.1038/s41408-021-00478-4
Knihovny.cz E-resources

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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

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ClinicalTrials.gov
NCT02283775, NCT02514668

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