The result updates from the randomised phase 3 IKEMA trial report an unprecedented benefit in progression-free survival (PFS) in patients treated with isatuximab-irfc plus carfilzomib and dexamethasone.
Despite available treatment options, many multiple myeloma (MM) patients experience disease relapse. Therefore, second-line treatments are needed to delay the disease progression. Towards this, a monoclonal antibody Isatuximab-irfc, directed at the CD38 (expressed on MM cells), was evaluated as a second-line treatment in the IKEMA trial.
The multicentre, open-label, randomised IKEMA trial enrolled 302 patients (median age=64 years) who were not refractory to prior anti-CD38 therapy and had received prior lines of treatment (one-three) except carfilzomib. Patients were randomly administered isatuximab-irfc plus carfilzomib and dexamethasone (n=179) or carfilzomib and dexamethasone alone (n=123) until progressive disease, unacceptable toxicity or patient request. The study’s primary endpoint was PFS assessed by an independent review committee. The secondary endpoint included overall response rate, rate of complete response or better, rate of very good partial response or better, rate of minimal residual disease negativity, OS and safety.
According to the updated results of the trial presented at the ESMO virtual plenary session, patients in the isatuximab-irfc arm had a median PFS of 35.7 months compared to 19.2 months (HR = 0.58; 95.4% CI, 0.42-0.79) in the control arm (carfilzomib-dexamethasone alone). When analysed following FDA recommendations, the PFS was even longer (41.7 vs 20.8 months). These benefits persisted across all subgroups of the patients. No new safety concerns were reported with the use of isatuximab-irfc.
The updated results of the IKEMA trial demonstrate a consistent benefit with the addition of isatuximab-irfc to carfilzomib and dexamethasone in patients with relapsed MM.