All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.
Bookmark this article
May 12, 2020 saw the early release of results from the phase III IKEMA (NCT03275285) trial following recommendation from an Independent Data Monitoring Committee.1 The randomized, open label, multicenter study evaluated the clinical benefit of the anti-CD38 agent, isatuximab, in combination with carfilzomib and dexamethasone vs carfilzomib and dexamethasone alone in patients with relapsed and/or refractory (RR) multiple myeloma (MM; RRMM) following 1 ‒ 3 prior lines of therapy.2
In this first planned interim analysis of the IKEMA trial, the addition of isatuximab to the carfilzomib plus dexamethasone regimen was associated with significantly improved progression-free survival (PFS) rates in patients with RRMM when compared to carfilzomib and dexamethasone alone. These data fulfil the primary endpoint for this study and no new safety concerns were observed.
Sanofi. Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma Paris Stock Exchange:SAN. globenewswire. https://www.globenewswire.com/news-release/2020/05/12/2031604/0/en/Sarclisa-isatuximab-Phase-3-IKEMA-trial-meets-primary-endpoint-early-in-patients-with-relapsed-multiple-myeloma.html. Published May 12, 2020. Accessed May 12, 2020.
Clinicaltrials.gov. Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients . https://clinicaltrials.gov/ct2/show/NCT03275285. Updated March 10, 2020. Accessed May 12, 2020.
EC approves isatuximab combined with carfilzomib and dexamethasone for the treatment of relapsed MM
On April 19, 2021, it was announced that the European Commission (EC) approved the use of isatuximab (Isa) in combination with carfilzomib and...
FDA approves isatuximab combined with carfilzomib and dexamethasone for the treatment of RRMM
On March 31, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of isatuximab (Isa) in combination with carfilzomib...
Subscribe to get the best content related to multiple myeloma delivered to your inbox