Isatuximab: First Approval

@article{Dhillon2020IsatuximabFA,
  title={Isatuximab: First Approval},
  author={Sohita Dhillon},
  journal={Drugs},
  year={2020},
  volume={80},
  pages={905-912}
}
Isatuximab (isatuximab-irfc; Sarclisa ® ) is an IgG1 monoclonal antibody that binds to the glycoprotein CD38 expressed on the surface of haematopoietic and tumour cells. It is being developed by Sanofi, under a license from Immunogen, for the treatment of haematological malignancies. In March 2020, intravenous isatuximab (in combination with pomalidomide and dexamethasone) was approved in the USA for the treatment of adult patients with multiple myeloma who have received ≥ 2 prior therapies… 

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References

SHOWING 1-10 OF 49 REFERENCES

In vivo vaccination effect in multiple myeloma patients treated with the monoclonal antibody isatuximab

This pilot study hypothesized that treatment with isatuximab would lead to the induction of novel endogenous tumor-specific antibody and T cell responses and performed immunomonitoring on all four patients who were consecutively enrolled at the University of Utah/Huntsman Cancer Institute.

Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design.

The design of a Phase III study (NCT03275285, IKEMA), which is evaluating isatuximab plus carfilzomib and low-dose dexamethasone, versus carfilZomib/dexamethAsone in relapsed/refractory multiple myeloma, and the primary end point is progression-free survival is described.

Phase I-b study of isatuximab + carfilzomib in relapsed and refractory multiple myeloma (RRMM).

Isatuximab is an anti-CD38 mAb with potent anti-myeloma effects as monotherapy or together with lenalidomide (Len) + dexamethasone (d) in RRMM.

Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma

Isatuximab demonstrated a manageable safety profile and clinical activity in patients with RRMM and the maximum tolerated dose (MTD) was not reached; no cumulative adverse reactions were noted.

The Mechanism of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Multiple Myeloma

This study provides a framework to understand response determinants in patients treated with isatuximab based on the number of MoA triggered by CD38 levels of expression, and for the design of effective combinations aimed at capitalizing disrupted tumor–stroma cell protection, augmenting NK lymphocyte–mediated ADCC, or facilitating ADCP in CD38lo MM patients.

A Phase Ib Study of Isatuximab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (VCDI) in Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplantation

Background: Isatuximab (ISA) is an anti-CD38 monoclonal antibody with multiple modes of action for killing tumor cells through direct tumor targeting and immune cell engagement. It has demonstrated

Results from a Phase II Study of Isatuximab As a Single Agent and in Combination with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

The baseline characteristics and demographic data from stage 2 at the selected dosing scheme from stage 1 are reported, and the full efficacy and safety data will be presented at the meeting.

Updated data from a phase II dose finding trial of single agent isatuximab (SAR650984, anti-CD38 mAb) in relapsed/refractory multiple myeloma (RRMM).

Isatuximab (ISA) is a humanized anti-CD38 monoclonal antibody with multiple modes of action for killing tumor cells through direct tumor targeting and immune cell engagement.

CD38 antibodies in multiple myeloma: back to the future.

Deep responses and prolonged progression-free survival can be achieved in relapsed/refractory MM patients when CD38 antibodies are combined with immunomodulatory agents or proteasome inhibitors, and CD38-targeting antibodies are generally well tolerated and induce partial response or better in heavily pretreated MM patients as monotherapy.

Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA Phase III study design.

The design of the Phase III ICARIA-MM study is described which will evaluate isatuximab in combination with pomalidomide (Pom) and low-dose dexamethasone (dex) (Poms/Dex) versus Pom/dex alone in RRMM.