Isatuximab: First Approval

  title={Isatuximab: First Approval},
  author={Sohita Dhillon},
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… 

Isatuximab, a novel anti-CD38 monoclonal antibody in the treatment of multiple myeloma: efficacy and safety

The article discusses the place of CD38 antibodies in the treatment of multiple myeloma and special emphasis is put on isatuximab, which in combination with pomalidomide and dexamethasone was approved in Russia in 2020.

Isatuximab in the Treatment of Multiple Myeloma: A Review and Comparison With Daratumumab

In this review, the structure, mechanisms of action, pharmacokinetics, pharmacogenetics, and safety profile of isatuximab in MM are summarized and it is compared with daratumumab in terms of mechanism and efficacy.

Immunotherapy of Multiple Myeloma: Promise and Challenges

This review covers the current scope of anti-myeloma immunotherapeutic agents, both those in clinical use and on the horizon, including naked mAbs, ADCs, bi- and multi-targeted m Abs, and CAR T-cells.

Emerging Monoclonal Antibodies for the Treatment of Multiple Myeloma

  • H. Abramson
  • Biology
    Monoclonal Antibodies [Working Title]
  • 2020
This review focuses on additional monoclonal antibodies currently under clinical study for MM, including several BCMAxCD3-directed bispecifics, the ADCs indatuximab ravtansine and STRO-001, and checkpoint inhibitors, although the future status of the latter is in a state of flux.

Isatuximab for the treatment of relapsed/refractory multiple myeloma

Isatuximab is approved in combination with pomalidomide/dexamethasone for the treatment of adults with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomides and a proteasome inhibitor.

Efficacy and mechanism of the anti-CD38 monoclonal antibody Daratumumab against primary effusion lymphoma

Findings provide preclinical evidence that Ab targeting of CD38 could be an effective therapeutic strategy for the treatment of PEL and clarify the antibody-dependent cell phagocytosis (ADCP).

Isatuximab: A Hopeful Drug for Multiple Myeloma

Patients with multiple myeloma may present with bone pain, pathological fracture, anemia, hypercalcemia, renal impairment and recurrent infection.

CD38 as a multifaceted immunotherapeutic target in CLL

How the enzyamtic and receptorial functions of CD38 contribute to CLL pathogenesis, the ability to exploit these functions for immunotherapeutic effect and development of novel strategies targeting CD38 are resolved.

Immune System Alterations in Multiple Myeloma: Molecular Mechanisms and Therapeutic Strategies to Reverse Immunosuppression

The alterations observed in symptomatic MM, as compared to its precursor stages and healthy subjects, in the main immune populations, especially the inhibition of effector cells and the activation of immunosuppressive populations are exposed.



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.