Sarclisa

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:

    • Patients who received at least two prior therapies
    • Patients who were refractory to their previous treatment(s)
    • Patients who have not responded to Revlimid or a proteasome inhibitor such as Velcade (bortezomib, Takeda Oncology), Kyprolis (carfilzomib, Amgen), or Ninlaro (ixazomib, Takeda Oncology)

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:

  • Low numbers of white blood cells known as neutrophils (neutropenia)
  • Infusion-related reactions
  • Pneumonia
  • Upper respiratory tract infection
  • Diarrhea
  • Anemia
  • Low numbers of white blood cells known as lymphocytes (lymphopenia)
  • Low platelet counts (thrombocytopenia)

In this study, the most common serious side effects included:

  • Pneumonia
  • Low numbers of white blood cells known as neutrophils and fever (febrile neutropenia)

How are the side effects of Sarclisa managed?

To reduce the risk and severity of infusion-related reactions, premedication agents are administered 15 to 60 minutes prior to starting a Sarclisa infusion.


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.

  • The study included 307 patients, of whom 154 received IsaPd and 153 Pd
  • More patients in the IsaPd group achieved a partial response or better (60% in the IsaPd group vs 35% in the Pd group)
  • The median progression-free survival was significantly longer in the IsaPd group than in the Pd group (11.5 months vs 6.5 months)

How is Sarclisa currently being studied in myeloma?

Sarclisa is being evaluated in clinical trials in the U.S.

  • In combination with Bendeka (bendamustine, Teva) and prednisone in penta-refractory MM(NCT04083898)
  • In combination with Velcade, cyclophosphamide, and dexamethasone in transplant-eligible MM patients (NCT04240054)
  • In combination with Revlimid and dexamethasone in patients with high-risk smoldering myeloma (NCT04270409)

Interested in learning more about Sarclisa clinical trials? Talk to an MMRF Patient Navigator to learn more or use our clinical trials finder:

FIND CLINICAL TRIALS

Created February 2020
Please visit the sponsor’s official patient site for up-to-date information on Sarclisa.