Isatuximab
- Generic Name
- Isatuximab
- Brand Names
- Sarclisa
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1461640-62-9
- Unique Ingredient Identifier
- R30772KCU0
- Background
Isatuximab (formerly SAR650984) is a humanized, IgG1-derived monoclonal antibody (mAb) produced from a Chinese hamster ovary (CHO) cell line. Structurally, isatuximab is comprised of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains. It is a cytolytic antibody targeted against CD38, a glycoprotein found on th...
- Indication
Isatuximab is indicated in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. It is also indicated in combination carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple ...
- Associated Conditions
- Multiple Myeloma (MM), Refractory Multiple Myeloma, Relapsed Multiple Myeloma
- Associated Therapies
- -
Isatuximab-Based Quadruplet Significantly Boosts PFS in Transplant-Eligible NDMM
Isa-RVd (isatuximab-irfc, lenalidomide, bortezomib, dexamethasone) as induction for 18 weeks, followed by autologous stem cell transplant, significantly reduced disease progression or death risk vs RVd in transplant-eligible newly diagnosed multiple myeloma patients, according to GMMG-HD7 trial data. The progression-free survival benefit was observed in most subgroups except those with WHO performance status over grade 1, high-risk cytogenetics, or R-ISS stage III disease. Isa-RVd also demonstrated deeper MRD-negative responses post-transplant compared to RVd.
Related Clinical Trials:
Isa-RVd Induction Provides Significant PFS Benefit in Newly Diagnosed Multiple Myeloma
Isa-RVd (isatuximab-irfc, lenalidomide, bortezomib, dexamethasone) improved progression-free survival (PFS) over RVd in transplant-eligible newly diagnosed multiple myeloma patients, with a 30% reduction in risk of disease progression or death. The benefit was observed in most subgroups except those with high-risk cytogenetics or advanced disease stages. Isa-RVd also showed deeper minimal residual disease (MRD) negativity post-transplant compared to RVd, translating to better PFS outcomes.
Related Clinical Trials:
FDA Roundup: Oncology Drug Alerts
In September, the FDA approved 9 new treatments for various cancers, including bortezomib for multiple myeloma and mantle cell lymphoma, ribociclib for breast cancer, biosimilar trastuzumab-strf for breast, gastric, and gastroesophageal cancers, and atezolizumab plus hyaluronidase for non-small cell lung, small cell lung, hepatocellular, melanoma, and alveolar soft part sarcoma. Other approvals included amivantamab-vmjw and osimertinib for non-small cell lung cancer, pembrolizumab for malignant pleural mesothelioma, isatuximab-irfc for multiple myeloma, and selpercatinib for thyroid cancer.
The OncFive: Top Oncology Articles for the Week of 9/29
FDA approves perioperative nivolumab for resectable NSCLC; locally produced CAR T-cell therapy shows 92% ORR in R/R multiple myeloma; FDA grants priority review to acalabrutinib for treatment-naive mantle cell lymphoma; September 2024 saw key FDA approvals in oncology; recap of September 2024 OncLive On Air episodes.
Related Clinical Trials:
September Roundup of Key FDA Approvals in Oncology
FDA approved bortezomib for multiple myeloma and mantle cell lymphoma, atezolizumab and hyaluronidase-tqjs for subcutaneous use in all IV atezolizumab indications, ribociclib plus an aromatase inhibitor for HR+/HER2- breast cancer, pembrolizumab plus chemo for malignant pleural mesothelioma, amivantamab plus chemo for EGFR+ advanced NSCLC post EGFR inhibition, isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma, osimertinib for locally advanced, unresectable EGFR+ NSCLC after chemoradiation, and selpercatinib for RET fusion+ medullary thyroid cancer.
Related Clinical Trials:
Quadruplet Therapy Shows Benefit for Newly Diagnosed Multiple Myeloma
Thomas G. Martin, MD, highlights the benefits of quadruplet therapy (Isa-VRd) for transplant-ineligible newly diagnosed multiple myeloma (NDMM) after FDA approval. The phase 3 IMROZ trial showed enhanced efficacy, higher minimal residual disease (MRD) negativity, and improved 60-month progression-free survival (PFS) with similar safety profiles. Martin emphasizes the therapy's potential to deepen and prolong remissions, making it a new standard for this patient population.
Related Clinical Trials:
Isa-KRd Induction Therapy Elicits Responses, MRD Negativity in Transplant-Eligible, Newly Diagnosed Multiple Myeloma Patients
The phase 3 IFM2020-02 MIDAS study interim analysis showed that 6 cycles of isatuximab-irfc, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) induction therapy achieved a 95% overall response rate (ORR) in newly diagnosed multiple myeloma patients eligible for transplant, with 63% MRD negativity at 10-5 and 47% at 10-6. The study also demonstrated manageable safety and successful stem cell collection. The ongoing MIDAS trial is evaluating an MRD-adapted consolidation and maintenance strategy following Isa-KRd induction.
Related Clinical Trials:
Drug Development Updates
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