The drug Sarclisa (isatuximab), from the pharmaceutical company Sanofi, has been authorized in Spain as a treatment for multiple myeloma, a type of cancer that affects blood cells in the bone marrow. Since last May 1, this new therapeutic option has been available in our country for two indications, IsaPd and IsaKd.
The indication for IsaPd, in combination with pomalidomide-dexamethasone (pom-dex), is for adult patients with relapsed and refractory multiple myeloma who have undergone a minimum of two prior therapies including lenalidomide and a proteasome inhibitor and have experienced a disease progression on last therapy. And the indication for IsaKd, in combination with carfilzomib and dexamethasone (Kd), is for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy.
Multiple myeloma is the second most common blood cancer, with 130,000 new cases diagnosed worldwide each year and around 39,000 cases in Europe. It is an incurable disease and most patients suffer a relapse. Relapsed or relapsed multiple myeloma is defined as cancer that comes back after treatment or a period of remission, while refractory multiple myeloma is cancer that does not respond to treatment or stops responding to treatment over time.
Every year 130,000 new cases of multiple myeloma are diagnosed worldwide and around 39,000 cases in Europe
“The fact that healthcare professionals in Spain can rely on isatuximab is highly relevant, as it represents an important therapeutic option for patients who are refractory to lenalidomide. Furthermore, it is the first and only anti-CD38 that has received approval for the IsaPd and IsaKad indications. At Sanofi we continue to work to offer cancer patients access to new therapeutic options that improve their quality of life”, said Salvador García, medical manager of the Sanofi Specialized Care unit.
Trials have demonstrated the safety and efficacy of isatuximab
Isatuximab is a monoclonal antibody that binds to a specific epitope of the CD38 receptor on multiple myeloma cells and has several mechanisms of action, including programmed tumor cell death (via direct apoptosis), ectoenzyme inhibition, and cytotoxic and immunomodulatory activity. .
The approval for the IsaPd indication was based on the results of the phase III ICARIA-MM trial in which isatuximab, in combination with pom-dex (pomalidomide and dexamethasone), reduced the risk of disease progression or death by 40%. compared to pom-dex.
In the case of IsaKd, the approval is based on the phase III IKEMA trial in which isatuximab, in combination with the standard of care carfilzomib and dexamethasone, reduced the risk of disease progression or death by 42%. Combination therapy with isatuximab was associated with a significant response, with undetectable levels of multiple myeloma observed in more than a third of patients (34%) with relapsed multiple myeloma.
The phase III IKEMA study, whose main endpoint is progression-free survival (PFS), involved 302 patients with relapsed multiple myeloma from 69 health centers in 16 countries. In Spain, 24 patients from five hospitals participated. And the latest results from this clinical trial, evaluating isatuximab in combination with carfilzomib and dexamethasone (Kd), showed a median progression-free survival (mPFS) of 35.7 months, compared to 19.2 months of patients treated with Kd alone, as assessed by an Independent Review Committee.
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