New CD38 Monoclonal Antibody Sarclisa® (isatuximab) Receives FDA Approval for Relapsed Multiple Myeloma
The FDA today approved a new monoclonal antibody targeting CD38 for the treatment of relapsed and refractory multiple myeloma patients. Sarclisa® (isatuximab) was approved in combination with pomalidomide and dexamethasone for patients who have already received at least two prior treatments that include lenalidomide (Revlimid) and a proteasome inhibitor.
The approval was made based on results from the ICARA-MM study, a Phase III study of 307 patients. Over 70% of the patients had received at least 3 prior lines of therapy and 71-74% of them were double refractory (meaning their myeloma was growing even while on a proteasome inhibitor and immunomodulatory drug).
There were two groups of patients in the study - 154 patients were treated with isatuximab/pomalidomide/dex and 153 patients were treated with pomalidomide and dex alone.
The study showed:
|Progression Free Survival||11.53 months||6.4 months|
|Overall Response Rate||60.4%||35.3%|
|Partial Response Rate||31.8%||8.5%|
|Near Complete Response Rate||15.6%||3.3%|
The depth of responses mattered - after 11.6 months of follow up, all of the patients who were MRD negative (MRD-) were still progression-free and alive.
Most common side effects (for 20% or more patients) was neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%) and diarrhea (26%).
Myeloma specialist Dr. Paul Richardson of Dana Farber Cancer Institute said:
"Most patients with multiple myeloma unfortunately relapse and become refractory to currently available therapies. Sarclisa used in combination with pomalidomide and dexamethasone offers an important new treatment option for patients in the United States living with this incurable disease. The pivotal ICARIA-MM trial was the first Phase 3 study of a CD38 antibody in combination with pom-dex to present results demonstrating significant clinical benefit in this setting. The study enrolled a broad population of patients with relapsed and refractory multiple myeloma that is particularly difficult to treat and with poor prognosis, which is reflective of real-world practice."
Sarclisa is given by IV. Similarly to daratumumab, the first infusion is longer (200 minutes) and the infusion time decreases after the third cycle (75 minutes). It is given at 10 mg/kg with pom/dex once a week for 4 weeks and then every 2 weeks after that.
For help with paying for Sarclisa, Sanofi has the CareASSIST Patient Support Program, which provides reimbursement support and financial assistance to eligible patients. For more information, please call 1-833-WE+CARE (1-833-930-2273) or visit SanofiCareAssist.com/Sarclisa.
It's great news to have yet another treatment option for relapsed or refractory myeloma patients and we look forward to seeing how myeloma specialists use it in the clinic.