What is Sarclisa?
Sarclisa, also known as isatuximab (SAR650984), is the newest anti-CD38 monoclonal antibody approved for use in multiple myeloma. Sarclisa is manufactured by Sanofi.
The MMRF and the Multiple Myeloma Research Consortium (MMRC) played a role in the early development of Sarclisa. The MMRC facilitated phase 1 and phase 2 clinical trials evaluating its use as a single agent and in combination with other myeloma therapies in patients with multiple myeloma.
How is Sarclisa used?
Sarclisa is used in combination with Pomalyst (pomalidomide, Celgene) and dexamethasone (IsaPd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two previous lines of treatment including Revlimid (lenalidomide, Celgene) and a proteasome inhibitor.
What types of patients can benefit from Sarclisa?
In a phase 3 clinical trial, Sarclisa (in combination with Pomalyst and dexamethasone) was shown to be effective in:
How does Sarclisa work?
Sarclisa binds to CD38, a marker protein found on the surface of myeloma cells (this protein is also found on other cells, such as red blood cells). It is thought to inhibit myeloma cell growth in several ways, including by directly affecting myeloma cells and by helping the immune system to seek and destroy myeloma cells.
How is Sarclisa administered?
Sarclisa is administered as an intravenous (IV) infusion at a dose of 10 mg/kg along with dexamethasone (40 mg orally or intravenously) every week of a 28-day cycle. In subsequent cycles, Sarclisa is only administered every 2 weeks. Pomalyst is given orally at a dose of 4 mg (on days 1 and 21). The combination of drugs is continued until the disease progresses or the patient experiences unacceptable toxicity.
What are the side effects of Sarclisa?
The most common side effects seen in a clinical study with IsaPd included:
In this study, the most common serious side effects included:
How are the side effects of Sarclisa managed?
What have Sarclisa clinical trials shown?
The approval of Sarclisa was based on results from the ICARIA-MM trial, a phase 3 trial conducted to determine the efficacy of Sarclisa combined with Pomalyst and dexamethasone (IsaPd) in patients with RRMM.
How is Sarclisa currently being studied in myeloma?
Sarclisa is being evaluated in clinical trials in the U.S.
Interested in learning more about Sarclisa clinical trials? Talk to an MMRF Patient Navigator to learn more or use our clinical trials finder:
Created February 2020
Please visit the sponsor’s official patient site for up-to-date information on Sarclisa.