Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 100 mg/5 mL [20 mg/mL], 500 mg/25 mL [20 mg/mL]) |
Drug Class | CD38-directed cytolytic antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
- Indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
- Indicated in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
Latest News
Summary
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- In relapsed/refractory multiple myeloma (RRMM) patients, isatuximab combined with or the immunomodulatory drugs (IMiDs) or proteasome inhibitors (PIs) plus dexamethasone significantly improved progression-free survival (PFS) (hazard ratio (HR): 0.552) and overall survival (OS) (HR: 0.737) compared to IMiDs or PIs plus dexamethasone alone.
- Isatuximab-based treatments showed higher overall response rates (ORR) compared to bortezomib/dexamethasone and lenalidomide/dexamethasone, with triple-drug regimens demonstrating the best probabilities for achieving superior ORRs.
- In specific subgroups, isatuximab significantly improved HR: 0.552, 95% confidence interval (CI) = 0.461 to 0.659, 95% prediction interval (PI) = 0.318 to 0.957 (PFS) in multiple myeloma patients with gain of chromosome 1q (+1q), and in lenalidomide-refractory multiple myeloma, isatuximab/pomalidomide/dexamethasone showed superior efficacy compared to dexamethasone alone.
- Isatuximab-based treatments were noted for producing the best treatment response quality for RRMM, with similar efficacy to daratumumab-based regimens.
- In patients treated with isatuximab-based regimens combined with IMiDs or PIs plus dexamethasone, higher rates of hematologic adverse events such as thrombocytopenia and neutropenia, and nonhematologic adverse events like upper respiratory tract infections, pneumonia, bronchitis, dyspnea, diarrhea, pyrexia, and fatigue, were observed.
- Infections, including pneumonia and upper respiratory tract infections, were more frequent in patients receiving anti-CD38 monoclonal antibodies (mAbs), including isatuximab, although there was no significant increased risk for varicella-zoster virus reactivation.
- Neutropenia (32.1%) was the most common hematologic adverse event, while cough (43.3%) was the most frequent nonhematologic event in various isatuximab-based triplet regimens. Severe adverse events were more common in regimens including isatuximab, panobinostat, and pomalidomide.
- Isatuximab demonstrated improved PFS in patients with RRMM, especially in subgroups with +1q chromosome abnormality and lenalidomide-refractory disease. These subgroups showed superior efficacy when treated with isatuximab-based regimens compared to standard therapies, highlighting its relevance in these specific populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Sarclisa (isatuximab-irfc) Prescribing Information. | 2024 | Sanofi-Aventis U.S. LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up | 2021 | Annals of Oncology |
Isatuximab: nursing considerations for use in the treatment of multiple myeloma | 2021 | Clinical Journal of Oncology Nursing |