Paul Hudson, CEO of Sanofi.
According to Marivi Mateosdirector of the Myeloma Unit of the University Hospital of Salamanca, “the treatment of patients with myeloma is changing due to the great advance both in research basic as in appearance of new drugs, which translates into a prolongation of survival. Access in our country to the combinations of Sarclisa with carfilzomib and dexamethasone, as well as with pomalidomide and dexamethasone, means that patients with myeloma in Spain who are in relapse can receive the combinations that are currently higher efficiency have shown and, therefore, that innovation reaches our patients”.
Approval for the IsaPd indication is based on the data from Phase III ICARIA-MM trial in which isatuximab, in combination with pom-dex (pomalidomide and dexamethasone), reduced the risk of progression or death by 40 percent compared to pom-dex.
In the case of IsaKd, the approval is based on the IKEMA phase III trial in which isatuximab, in combination with standard of care carfilzomib and dexamethasone, reduced the risk of disease progression or death in a 42 percent. Combination therapy with isatuximab was associated with a remarkable depth of response, with undetectable levels of multiple myeloma observed in more than one-third of patients (34 percent) with relapsed multiple myeloma.
“The fact that health professionals in Spain can count on isatuximab is very relevant since it represents an important therapeutic option for patients refractory to lenalidomide. Furthermore, it is the first and only anti-CD38 that has received approval for the IsaPd and IsaKad indications. From Sanofi We continue to work to offer cancer patients access to new therapeutic options that improve their quality of life”, he states. Salvador Garciamedical manager of the Sanofi Specialized Care unit.
Safety and efficacy profile of isatuximab
Regarding the data from the phase III IKEMA study, a clinical trial open-label, multicenter, randomized phase 3 study that included 302 patients with relapsed multiple myeloma from 69 centers in 16 countries. In Spain, 24 patients from 5 hospitals participated. IKEMA’s primary endpoint is progression-free survival (PFS).
The latest results from the IKEMA phase 3 clinical trial, evaluating isatuximab in combination with carfilzomib and dexamethasone (Kd), showed a median of progression free survival (mPFS) of 35.7 months (Hazard Ratio [HR] 0.58; Confidence interval [IC] 95 percent: 25.8 to 44.0; n=179), compared to 19.2 months for patients treated with Kd alone (95% CI 15.8 to 25.1, n=123), as assessed by a Independent Review Committee. IsaKd treatment reduced the risk of disease progression or death by 42 percent (HR = 0.58; 95 percent CI 0.42-0.79) compared with standard-of-care Kd in patients with multiple myeloma.
The benefit it remained constant in all patient populations, including those with a worse prognosis, such as patients refractory to lenalidomide, with high-risk cytogenetics, compromised renal function, or elderly. Besides, the survival rate 3 and a half years after starting treatment with IsaKd is 66%.
These are the best results obtained in relapsed and/or refractory multiple myeloma (RRMM) with a proteasome inhibitor-based regimen to date in terms of depth of response and PFS.
“Patients who are refractory to lenalidomide after first-line treatment are becoming more frequent and have limited salvage options. The approval of this combination based on Isatuximab, a new anti-CD38 monoclonal antibody, finally allows us to have a alternative that induces very deep responsesincluding complete remissions with disappearance of minimal residual disease in one-third of patients, and which has shown a clear progression-free survival advantage in this poor-prognosis population.” Enrique M. Leisurehead of the Hematology Service at the Marqués de Valdecilla University Hospital (Santander).
In the ICARIA-MM phase III study, isatuximab in combination with pom-dex n = 154) demonstrated a statistically significant improvement in progression-free survival (PFS), with a median PFS, defined as time to disease progression or death, of 11.53 months compared to 6, 47 months on pom-dex alone (n = 153) (HR: 0.596, 95 percent CI: 0.44-0.81, p = 0.001).
Combined treatment with Sarclisa also demonstrated a significantly higher overall response rate compared to pom-dex alone treatment (60.4 percent vs. 35.3 percent, p < 0.0001). In additional analyses, combination treatment with isatuximab compared to pom-dex alone showed a consistent therapeutic benefit in selected subgroups reflecting actual practice, including patients refractory to lenalidomide, patients with high-risk cytogenetics, those over 75 years of age, patients with renal insufficiency, and patients refractory to lenalidomide.
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