Sanofi's CD38 Antibody Sarclisa Receives FDA Approval in Combination Therapy, Reducing Disease Progression Risk by 45% in Relapsed/Refractory Multiple Myeloma

Today, Sanofi announced that the U.S. FDA has approved Sarclisa (isatuximab), a CD38 antibody, in combination with carfilzomib and dexamethasone (Kd) as standard therapy for patients with relapsed/refractory multiple myeloma (MM) who have received 1–3 prior lines of therapy. This marks the second FDA approval for Sarclisa.

Multiple myeloma (MM) is the second most common hematologic malignancy, with over 130,000 newly diagnosed cases globally each year. Despite available treatments, MM remains an incurable malignant disease and is associated with a significant patient burden. As there is no cure for MM, most patients experience relapse. Relapsed MM refers to the recurrence of cancer after treatment or following a period of remission.

Sarclisa is a monoclonal antibody that specifically binds to the CD38 receptor expressed on MM cells. It exerts its effects through multiple mechanisms of action, including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

The FDA approval was based on the results of IKEMA, a randomized, double-blind, open-label Phase 3 clinical trial. The trial results demonstrated that Sarclisa combination therapy reduced the risk of disease progression or death by 45% compared with standard Kd therapy (HR=0.548, p=0.0032). At the time of the interim analysis, the median progression-free survival (PFS) in the Kd treatment group was 19.15 months, whereas the median PFS had not yet been reached in patients receiving Sarclisa combination therapy.

In China, isatuximab was approved for clinical use last July, intended for the treatment of high-risk smoldering multiple myeloma. It is also undergoing two clinical trials in China:

One is a randomized, open-label, international, multicenter Phase 3 clinical trial designed to compare the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone alone in prolonging progression-free survival in patients with newly diagnosed multiple myeloma who are ineligible for transplantation;

Another study is a Phase I clinical trial aimed at evaluating the pharmacokinetics, safety, and preliminary efficacy of isatuximab in Chinese patients with relapsed and/or refractory multiple myeloma.

Note: The original text has been abridged.

References:

[1] FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Retrieved March 31, 2021, from https://www.globenewswire.com/news-release/2021/03/31/2202919/0/en/FDA-approves-Sarclisa-isatuximab-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-relapsed-or-refractory-multiple-myeloma.html

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