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Isatuximab combination therapy for relapsed and refractory multiple myeloma | Results from the phase III IKEMA trial

May 13, 2020

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 theanti-CD38 agent, isatuximab, in combination with carfilzomib and dexamethasone vscarfilzomib and dexamethasone alone in patients with relapsed and/or refractory (RR) multiple myeloma (MM; RRMM) following 13 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.

IKEMA trial

  • Isatuximab (10 mg/kg) was administered by intravenous (IV) infusion once weekly for 4 weeks, and then biweekly in 28-day cycles in combination with
    • carfilzomib (IV, 20/56 mg/m 2) twice weekly the first three weeks of each cycle
    • dexamethasone (IV or oral, standard dose) for the entirety of treatment
  • Primary endpoint: PFS
  • Secondary endpoints: overall response rate, very good partial response or greater, minimal residual disease, complete response rate, overall survival, and safety.
  • Key exclusion criteria:
    • previously treated with carfilzomib
    • primary refractory
    • free light chain measurable disease only
    • Eastern Cooperative Oncology Group (ECOG) performance status > 2

Isatuximab recently received approval in Europe and the US for the treatment of RRMM in combination with pomalidomide and dexamethasone.

  1. 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.

  2. 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.